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EO STERILIZATION PLANT
USER MANUAL

Rev04 04/08/2022 GP §6.2 DEC

Rev03 01/07/2022 GP Update
Rev02 30/03/2021 DS KV Update
Rev01 15/01/2020 GDV KV Creation

Version Date Author Checked by Change Description

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SUMMARY
1. INTRODUCTION................................................................................................................................................................................ 5
2. INSTALLATION DESCRIPTION AND PURPOSE ...................................................................................................................... 5
STERILIZATION CHAMBER ................................................................................................................................................................................ 5
DOORS ................................................................................................................................................................................................................. 5
WATER JACKET .................................................................................................................................................................................................. 5
RECIRCULATION ................................................................................................................................................................................................ 5
VACUUM PUMP(S) ............................................................................................................................................................................................. 6
VACUUM BREAK ................................................................................................................................................................................................. 6
VAPORIZER ......................................................................................................................................................................................................... 6
STEAM GENERATOR........................................................................................................................................................................................... 6
OPTIONAL EQUIPMENT ..................................................................................................................................................................................... 6
Pre-conditioning rooms ................................................................................................................................................................... 6
Desorption rooms ............................................................................................................................................................................... 6
Gas treatments .................................................................................................................................................................................... 7
Energy supplies ................................................................................................................................................................................... 7
Conveyors............................................................................................................................................................................................... 7
3. HANDLING & POSITIONING.......................................................................................................................................................... 8
4. SAFETY ................................................................................................................................................................................................ 9
POTENTIAL RISKS .............................................................................................................................................................................................. 9
Ethylene oxide ...................................................................................................................................................................................... 9
Electricity............................................................................................................................................................................................... 9
Heat.......................................................................................................................................................................................................... 9
Mechanic / Pressure .......................................................................................................................................................................... 9
RISKS ANALYSIS AND PROCEDURES ................................................................................................................................................................ 9
SAFETY PACK (OPTION)................................................................................................................................................................................. 10
EMERGENCY STOPS ........................................................................................................................................................................................ 10
OTHER SAFETY COMPONENTS ...................................................................................................................................................................... 11
ALARMS MANAGEMENT ................................................................................................................................................................................. 11
CYCLE CANCELLATION BEHAVIOURS ........................................................................................................................................................... 11
5. CONTROL-COMMAND SYSTEM GENERAL DESCRIPTION ................................................................................................ 12
AUTOMATIC CONTROLLER ............................................................................................................................................................................ 12
HUMAN MACHINE INTERFACE (HMI) ....................................................................................................................................................... 12
SYSTEM ARCHITECTURE................................................................................................................................................................................ 13
6. GENERAL DESCRIPTION OF CYCLE STEPS ........................................................................................................................... 14
PRECONDITIONING CYCLE ............................................................................................................................................................................. 14
STERILIZATION CYCLE ................................................................................................................................................................................... 14
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DESORPTION CYCLE ....................................................................................................................................................................................... 15

7. HUMAN MACHINE INTERFACE ................................................................................................................................................. 16
GENERAL NAVIGATION .................................................................................................................................................................................. 16
LOG IN .............................................................................................................................................................................................................. 17
PROCESS PAGES............................................................................................................................................................................................... 19
Examples ..............................................................................................................................................................................................19
HMI Process components description .......................................................................................................................................22
8. OPERATING MODES ..................................................................................................................................................................... 27
AUTOMATIC MODE ......................................................................................................................................................................................... 27
MANUAL MODE ............................................................................................................................................................................................... 27
OPERATING MODE SWITCHOVER.................................................................................................................................................................. 29
9. OTHER PAGES ................................................................................................................................................................................ 30
TOOLBAR ......................................................................................................................................................................................................... 30
CALIBRATION PAGE ........................................................................................................................................................................................ 30
MOTOR HOURS PAGE ...................................................................................................................................................................................... 30
ALARM PAGE ................................................................................................................................................................................................... 31
ALARM HISTORY PAGE ................................................................................................................................................................................... 31
CURVES PAGE .................................................................................................................................................................................................. 32
EO BOTTLES SETUP PAGE .............................................................................................................................................................................. 32
RECIPES MANAGEMENT PAGE ....................................................................................................................................................................... 33
REPORT MANAGEMENT PAGES ..................................................................................................................................................................... 33
STERILIZATION PAGE (CYCLE LAUNCHER) ................................................................................................................................................. 34
PRE-CONDITIONING / DESORPTION PAGES (CYCLE LAUNCHER)............................................................................................................ 34
10.STERILIZATION CYCLES MANAGEMENT .............................................................................................................................. 35
DAILY ROUTINE CHECKS ................................................................................................................................................................................ 35
In the control room: .........................................................................................................................................................................35
On the chamber .................................................................................................................................................................................35
On the vaporizer heating skid .....................................................................................................................................................35
On the vacuum pumps ....................................................................................................................................................................35
On the vaporizer ...............................................................................................................................................................................35
START STERILIZATION CYCLE ....................................................................................................................................................................... 36
STOP STERILIZATION CYCLE.......................................................................................................................................................................... 36
CANCEL STERILIZATION CYCLE..................................................................................................................................................................... 36
11.BASIC MAINTENANCE.................................................................................................................................................................. 37
PREVENTIVE MAINTENANCE PLAN .............................................................................................................................................................. 37
ADVISED SPARE PARTS .................................................................................................................................................................................. 39
ADDITIONAL MAINTENANCE INFORMATION .............................................................................................................................................. 40
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DOOR GASKET REPLACEMENT ...................................................................................................................................................................... 40

EO BOTTLE REPLACEMENT ........................................................................................................................................................................... 40
ANNEXES ................................................................................................................................................................................................ 41
12.ANNEX I - LIST OF ALARMS DISPLAYED ON THE HMI ..................................................................................................... 42
13.ANNEX II – CYCLE PARAMETERS FOR CYCLE RECIPE CREATION ................................................................................ 51
14.ANNEX III – CHAMBER SETUP PARAMETERS ..................................................................................................................... 56
15.ANNEX V – TROUBLESHOOTING .............................................................................................................................................. 61
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1. INTRODUCTION
This document gives to any users the necessary information to understand, control, supervise and maintain the performances
of the sterilization system.
It describes the purpose of the installation, its behaviour, its operating and shutdown modes, the safety features, the Human-
Machine Interface (HMI) and the management of alarms and messages.
Furthermore, it gives clues to perform a first level of maintenance and diagnosis/troubleshooting in case of issue.

2. INSTALLATION DESCRIPTION AND PURPOSE

The purpose of the installation is the sterilization of your products through the execution of ethylene oxide (EO) cycles under
vacuum. Usually installation includes the following equipment:

Sterilization chamber
The sterilization chamber is the main part of the sterilizer,
the vessel where the operator places the pallets of
products (also called the load).

Doors
Chamber is equipped with one or two doors (according to
your specification), called loading door and unloading
door. They usually are automatic and move by horizontal
translation using pneumatic cylinders, but they can also be
vertical, using hydraulic cylinders or completely manual.
Inflatable gaskets are placed on the chamber to seal it.

Water Jacket
The water jacket is a water loop all around the sterilization chamber heated to the sterilization
temperature (usually between 40 to 60°C) by its dedicated heating system. The heating system is
usually place on the top of the chamber. According to your specification, heating system can be
electrical or use your factory hot water loop.

Recirculation
The chamber recirculation system: it is a fan included in the chamber. Air is taken from one inlet at the top of
the chamber and blow from one or two outlets at bottom of the chamber (opposite side of the inlet). Its
purpose is to well mix the gas inside the chamber in order to have a good homogeneous temperature, humidity
and EO concentration.
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Vacuum pump(s)
The vacuum pump(s) are used to extract the air inside the chamber at the beginning of the
cycle and the gas after the sterilization gas exposure. Vacuum pumps must be placed in a
specific area because of the explosivity and toxicity hazards. Please, refer to the risk analysis
for more details.

Vacuum break
The vacuum break is a filtered air inlet to return the chamber at atmospheric pressure at the
end of the sterilization cycle. For some specific use (such as sutures), an additional line air can
be installed to inject compressed air (quick dry process).

Vaporizer
The vaporizer heats up the liquid EO from the bottles to be injected in
as a gas inside the chamber. Nitrogen is also going through the
vaporizer to be heated and to flush the EO in the equipment. Similar
to the water jacket, the vaporizer has its own heating system using
electrical element or your factory hot water loop.
The Vaporizer must be placed in a specific area because of the
explosivity and toxicity hazards. Please, refer to the risk analysis for
more details.

Steam generator
The steam is used to get a good amount of humidity during the sterilisation cycle. According to
your facilities, if a correct steam can be provided the steam generator will be optional.

Optional equipment

Pre-conditioning rooms
In order to improve the sterilisation process, pre-conditioning room can be
installed. They preheat and humidify the products before to be placed inside the
sterilizer chamber. At atmospheric pressure, the air circulation is heated by
electrical elements or hot water loop and humidification is done by steam.

Desorption rooms
After being exposed to the EO, the product can have some EO residues and degas
them during a long time after the end of the sterilisation cycle. In order to remove
those residues, products can be placed in desorption rooms. At atmospheric
pressure, air is heated up, recirculated and extracted
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Gas treatments
Every gas mixture extract from the chamber and the desorption rooms can contain EO.
There necessity and efficiency requirements might depend of the location they will be
installed (country’s laws and specifications).

Scrubber
This device is a combination of washing towers and reactors where acid water is
circulating to transform by chemical reaction the ethylene oxide into ethylene glycol. One
washing tower on top of one reactor is called a stage. Depending on the condition, every
stage reduces by 90% the amount of EO in the air. A scrubber can have 3 successive
stages in order to reduce a maximum of EO. An additional tank is used to increase the
water volume to delay the emptying period up to 6 months.

Energy supplies

Water treatment
Water treatment can be installed on the water supply of the steam generator to improve the quality of steam and to prevent
damaged caused by city water. Their design depends of your installation and quality specifications. Details about them are
described in another document.

Nitrogen generator
Nitrogen is an important supply for the EO sterilizer as it is used as an inert gas to keep a non-flammable mix of gas at any time
inside the chamber. Nitrogen supply can be done by bottles or rack of bottles purchased from a specific factory. Due to a large
and constant consumption, we recommend to have a Nitrogen generator with a sufficient buffer tank according to the sterilizer
chamber volume. It is required to have 98% purity level for the nitrogen supply.

Air compressor
Compressed air supply is used to activate pneumatic components (mostly valves and cylinders). Compressed air supply can be
done by a plant supply or a dedicated compressor to the steriliser.

Conveyors
According to the production line, conveyors can be installed to automatically load pre-conditioning rooms, sterilisation
chambers, desorption rooms, loading areas, etc. They can be electric or pneumatic. Their design depends of your installation.
Details about them are described in another document.
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3. HANDLING & POSITIONING

Sterilization chamber and its equipment (inside the chamber and separated if necessary) are shipped on site by trucks and can
heavy. Refer to the packing list of your shipment for mor details.
Handling is mostly done by a crane using specifics handling rings on the top of the chamber.

The chamber can be lifted from the ground using hydraulic jacks carefully placed on the chamber side feet on the 4 bottom
corners of the chamber.
Chamber can be moved to its final position using specific rolls to support its weight.
After emptying, it is important to level the chamber.
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4. SAFETY
Potential risks
This chapter presents the potential risks of the installation due to the energies and material used. It is important to well
understand the potential risks to make sure you are constantly safe and secure to prevent any heavy consequences on people,
goods and environment. This is NOT the Risks Assessment, for more details, please refer to it.

Ethylene oxide
Ethylene oxide is liquid pressurized to 8bar inside the bottle and gas after being heated inside the vaporizer. It is a very dangerous
material: flammable, explosive, cancerogenic, toxic, etc.

Electricity
Electricity is used on most of the equipment including some high voltage (400VAC) and high intensity (until
250A on some electrical cabinet). So, it is important to be qualified to work on those components.

Heat
Steam presents pressure danger but also heat. Steam pressure can reach 3bar and be around 140°C. Other
surfaces can be hot from 40 to 80°C such as water jacket, vaporizer and their heating systems.

Mechanic / Pressure
Under pressure or vacuum present some mechanic risks. Other mechanical risks are presents with moving
component such as recirculation, motors, fans, doors, pneumatic cylinders, etc.
An attention to the door manipulation is required. Operators must check there is nobody inside the chamber
(loading or unloading for example) before to close the doors.

Risks analysis and procedures

It remains to the client responsibility to analyse the risks and prevent them. Make sure you are always aware, trained and
qualified on those risks and well know the risks management procedures such as Personal Protective Equipment (PPE) to use,
Evacuation, etc.
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Safety pack (option)

Your installation might include a Safety pack. It is composed by:

• EO detection central
• Associated with EO detectors in critical areas: at least one on every ATEX rooms such as vacuum pumps / vaporizer /
gas treatment rooms.
• Portative EO detectors
• Personal Protective equipment for the operators (such as filtration masks)

Emergency stops
Emergency press buttons are available on the installation, at least:
• One on the door of the electrical cabinet
• One on every hazardous area such as vaporizer / vacuum pump / gas treatment rooms
• And a reset button on the door of the electrical cabinet.
If an emergency stop occurs, the 24VDC power supply to the electrical cabinet is cut off, which leads to a cut-off of all actuators
(electric and pneumatic), as well as the commands from the automatic controller (PLC). If the emergency stop happens during a
sterilization cycle, it will pause the cycle and wait the action of the user. The operator is warned by an alarm message on the HMI
and to re-start the installation. It is necessary to:
• Solve the cause of the emergency shutdown by qualified people (maintenance staffs)
• Cancel the emergency shutdown (if one of the emergency push buttons was pressed, unlatch it in order to return to its
original position).
• Reset the emergency shutdown by using the blue reset button in the electrical cabinet.
The installation goes back on:
• If the emergency stop happened off cycle, the actuators will be repowered and waiting for order.
• If the emergency stop happened during a sterilization cycle, the cycle in progress has been paused. Cycle will continue
from where it was doing before the emergency stop (alarm level 2). If the pause has been too long, it is possible to get
other alarms after an emergency stop. Qualified people will need to analyse them and find out if the cycle must be
manually cancelled.
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Other safety components

Here after the list of safety components:
PSH111: no injection is possible if the chamber pressure is not below atmospheric pressure
PSH601: stops the steam generator if the pressure is too high.
TSH201: stops the water jacket heating system if the temperature is too high.
SRE301: releases the gas pressure if too high inside the vaporizer when too high.
SRE201: releases the water pressure inside the water jacket heating system when too high.
SRE601: releases the steam pressure of the steam generator when too high.
SRE401: releases the water pressure inside the vaporizer heating system when too high.
CV161: avoids gas pressure rising above atmospheric pressure inside the sterilisation chamber.

Alarms management
There are four different types of alarm depending on their impact on the processing cycle:
Level 1: The information is displayed only as a warning for the operator. For example, when maintenance service must be
planned.
Level 2: Event pausing any actions in progress of the installation to pause: cycle is paused, and actuators are disabled. The cycle
starts again at the point where it was stopped, after the cause has been solved and the acknowledgement of the alarm. For
example, after a sensor fault (broken wire).
When the sterilizer is paused, it decreases its temperature regulation, recirculation flows etc. So it is important to solve the
problem as fast as possible.
Level 3: Events driving the installation to stop and cancellation of the cycle in progress. Example: operator cancellation. For
example, if there is a leak detected on the chamber during the gas exposure.
Level 4: Events related to the vacuum pumps driving the installation to pause and then, when problem solved and alarm
acknowledged, to the cancellation of the cycle in progress. For example, when the temperature of the vacuum pump is too high.
If one of the vacuum pumps is in fault it’s possible to isolate it for done the cycle cancellation. This function can be activate from
the configuration page. The vacuum pump alarms can be acknowledged.
All faults, alarms and events are displayed on the HMI. The operator can acknowledge faults and alarms from it.
One page of the HMI is dedicated to the occurring alarms. A history of alarms is also record and available to be displayed on the
HMI.

Cycle cancellation behaviours

If a level 3 or level 4 alarm occur, as mentioned, the cycle in progress is cancelled. However, cancelation behaviour is not the
same before or after the EO injection phases.
if the cancellation happened before the EO injection phases: the system automatically returns to atmospheric pressure.
if the cancellation happened during the EO injection phases: the system goes to the post-treatment steps (with nitrogen flushes
and then air flushes) as describes in the cycle recipe.
Finally, if the cancellation happened after the EO injection phases: the cycle continues the post treatment steps as describes in
the cycle recipe with the “cancellation in progress” indication.
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5. CONTROL-COMMAND SYSTEM GENERAL DESCRIPTION

Automatic controller
The automatic controller (or PLC, from Programmable Logic Controller) is the electronic brain of the installation. It handles the
data coming from the system (sensor’s outputs, system variables such as pressure, temperature, etc.) and processes it through
a program installed on it and gives a response by activating/deactivating the actuators in the installation. It also performs
communication tasks with other control boxes (if applicable) and can perform sequences of commands. Summarizing, it allows
the automatic control of the system but also the manual control (refer to later sections for performance mode details); except
for hard wire security features, almost every interaction between the user and the system passes through the PLC.
The CPU of the PLC includes a Profinet Ethernet port and an MPI/DP port for communication.

Human Machine Interface (HMI)

The HMI allows the user to access certain parameters of the PLC program in order to control the installation. Many devices can
be considered as HMIs. In this case, the HMI a desktop computer and/or a touch screen panel placed in the control room. Inside
it, a program developed by MDS and exclusively for the client is installed. Its purpose is to present a user-friendly interface to
ease the control and supervision of the installation. The HMI allows to establish a hierarchy of users so that different levels of
staff have different access and rights to interact with the system (for instance, a guest user doesn’t have access to the
maintenance options); it allows to visualize in one single view (or several views depending on the size of the installation) the
main parameters of the sterilization cycle, to visualize the alarms occurring in any part of the system and to store and follow
trends in the data (for instance, pressure and humidity curves) amongst other things.
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System Architecture

Please refer to the hardware and software designs specifications for more details on equipment.
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6. GENERAL DESCRIPTION OF CYCLE STEPS

Preconditioning cycle
The pre-conditioning is important to improve the sterilization process. It prepares the products to get a homogeneous
temperature and humidity of the goods. After the room is closed and cycle launched the preconditioning room heat up and
humidify to the regulation points. When the setpoints are reached, cycle counter start to the defined time. A recirculation fan is
used to get homogeneous values. The preconditioning steps can be done inside the sterilizer, but it increases a lot the cycle time
and so slow down the production flow.

Sterilization cycle
The EO sterilisation cycle uses the different steps. Each step is fully adjustable with parameters. The list of parameters is an
annexe of this document.
Find bellow the list of steps and their purpose:
Pre-conditioning: The sterilizer stays around the atmospheric pressure, it pre-heats and pre-humidifies the load to defined
setpoint. This step depends of the load and can be optional.
Initial phase: Gaskets are inflated. An integrity test is performed to verify the gaskets are good. The vacuum pump is pre-heated.
Low leak test: Vacuum is pulled until a certain setpoint. Then the pressure is stabilised and hold for a certain time.
High leak test: after the low leak test, Nitrogen is injected to the sterilizer chamber until the defined high pressure setpoint.
Similar to the low leak test, the pressure is stabilised and hold for a certain time. This phase is also used to flush the chamber
with inert gas.
If the pressure increases too much during one of the leak tests, it means the chamber is leaking (atmospheric air is going in), the
cycle will be cancelled, and the sterilizer will require maintenance actions.
Humidification: There are different humidification management. This step is used to condition the load to the defined
temperature and humidity ranges.
DEC (Dynamic Environment Conditioning) heats the load with successive injections of steam and nitrogen. Steam injection takes
place in a vacuum, which allows the charge to heat up faster than at atmospheric pressure. By injecting nitrogen, the humidity
level set in the chamber is not exceeded, and thus the load does not get wet. The use of DEC is essential if the installation does
not have a preconditioning chamber.
The steam injection after the DEC phase is used to reach the humidity set point. This injection is also performed when DEC is not
in use.
Important note: If your system vacuum pump is a lubricated vanes vacuum pump, please contact MDS to set DEC parameters.
Lubricated vane pumps can be damaged by excessive humidity. MDS is not responsible for damage to the vacuum pump when
making DEC adjustments without MDS assistance
Injections: One injection step is combined by different gas injection such as Steam, Nitrogen, EO. Those gas injections required
a study to define the correct amount of gas. They must be alternated in order to constantly stay in with a non-explosive mix
inside the chamber.
Exposure: After all injections, pressure is hold during a certain time. It is the phase where the products are sterilized. The pressure
can slightly decrease during this step because of an absorption phenomenon of the EO by the product. After the exposure, the
load can be considered as sterilized, but it is not proper to be used.
Rinsing: First rinsing step must be done with nitrogen to flush the chamber (remove the EO gas). Other flushes are done to
continue to remove a maximum of EO residues of the product. Last flushes can be done with air.
Desorption: It is a successive flush with different stabilisation time to help the EO residues to be removed from the products.
This step depends of the load and can be optional.
Extra-rinsing: After the minimum flushes are done, the sterilizer will wait the operator to unload the products. If the operator
does open the door after a certain period, the sterilizer will be re-flush to remove the few EO residues degassed.
End of cycle: after acknowledgement by the operator, the sterilizer goes back to atmospheric pressure and deflates the gaskets.
HMI allows the operator to open the unloading door.
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Desorption cycle
The desorption is important to remove a maximum of EO residues of the products. After the room is closed and cycle launched
the desorption room heat up the regulation point. When the setpoint is reached, cycle counter starts to the defined time. In
addition to the recirculation flow for homogeneous temperatures, and fan extract the polluted air to the gas treatment or outside
of the building. The desorption steps can be done inside the sterilizer, but it increases a lot the cycle time and so slow down the
production flow.
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7. HUMAN MACHINE INTERFACE

Main functions of the HMI are:
• Start / cancel / valid the end of a sterilization cycle.
• Inform the user of the cycle step.
• Display the different actuators (outputs) and sensors (inputs) of the process to visualize their status.
• Calibrate the sterilizer analogue inputs such as pressure, temperature, relative humidity, weight, gas transmitters.
• Switchover automatic / manual modes.
• Archive, display and set the recipes for the sterilization cycle.
• Display, acknowledge, archives the eventual alarms and events.
• Archive and display cycle reports and associated graphs.
• Archive and display the actions (events) recorded in an audit trail.
• Open and close user sessions and manage user accounts and passwords (to allow different access level)
Be aware that any information fulfilled on the HMI by any user must be validate by pressing “ENTER” on the keyboard.

General navigation
The HMI displays different pages types of information. The shape of the pages is always composed by an upper and lower band
which are constantly displaying main information. On the main page, you can access to every different page. Some functions or
pages are locked and required a specific login to access. There is different access level.

Most important sensors for Cycle stage / Sterilizer status Home page
sterilization cycle Operating mode access

Alarm page access Date / Time

Optional information
Login / Logout button
Other pages access Actual User
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Log in
A few visualizations are available if no one is logged in the HMI. But most of the actions needs to be logged in to identify which
user is using the equipment.
To log in to the HMI, you need to press the button login, a pop-up appears to ask your username and password. It is important
to press “Enter” on your keyboard to valid both before to confirm.
After a few try using a wrong password, the user account will be locked.
The Administrator user type can create new user account, unlock them or modify passwords and change their access level
(operator, maintenance, pharmacist, administrator).

After every commissioning on site, basic training are done to every user type.
There are five different access levels. According to with which of them the user is logged in, different information will be displayed
on the HMI.
- Guest
- Operator
- Maintenance
- Administrator
- Quality
- Pharmacist
- System Engineer
These access levels may be configured as follows:

System Engineer
Administrator
Maintenance

Pharmacist

Page name
Operator

Quality

Cycle start X X X
Process X X X X X X
Engineer mode X X X X X X
Settings X X X X X X
Alarms visualization X X X X X X
Alarms acknowledge X X X X
Alarms History X X X
Cycle parameters modification X X X
Users set up X X X X X X
Cycle parameters viewer X X X X X X
Manual mode X X X
Cycle cancellation X X X
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System Engineer
Administrator
Maintenance

Pharmacist
Page name

Operator

Quality
End cycle validation X X X
Printing of the last cycle X X X X X X
Transmitters calibration X X X
EO data X X X
Cycle in progress X X X
Autoclave set up X X X X
Exit Runtime X X X
Safety rinsing parameters X

*: Only access to connected account password modification

**: Access to all existing user accounts
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Process pages
Process pages schematic representations of the installation and similar to the Process and Instrumentation Diagram (P&ID). Only
unnecessary components to display have been removed to simplify its use. Important components of the process are displayed
such as pressure, temperature, humidity, gas concentration transmitters, the most important component like the valves, fans,
pumps, heaters, etc.
The first and most important process page is the view of the sterilizer (lateral view). The supplies (Nitrogen, Compressed air),
doors and gaskets are displayed on this process page. Also, from this page, access buttons are available to navigate on other
process pages.

Examples
Example of Sterilizer process page:
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Example of Scrubber process page:

Example of Vacuum Pumps process page:

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Example of Vaporizer process page (including the vaporizer heating skid):

Example of Steam generator process page:

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HMI Process components description

Component type Color Description

Recirculation fan is working (ON). Inlet is in the middle and at

the top of the sterilization chamber. Outlets are at the bottom
on the opposite side of the chamber. Recirculation is
constantly on during the sterilization cycles to mix the gas
inside the chamber and have a good homogeneous
temperature, humidity and gas concentration.

Recirculation fan
(RCxxx) Recirculation fan is not working (OFF).

Circuit breaker has been triggered. Action is stopped,

problem must be analysed and fixed by qualified people.

Back venting is working (ON). It starts at the end of the cycle

as soon as the unloading door is opened. It generates an air
flow from the chamber to the gas treatment to evacuate the
potential EO residues and avoid operator exposition.

Back venting
(BVxxx) Back venting is not working (OFF).

Circuit breaker has been triggered. Action is stopped,

problem must be analysed and fixed by qualified people.

Feed pump is working (ON). It takes water from the supply to

the steam generator. It turns automatically on if the low-level
sensor does not detect a correct level (LSLxxx).

Feed Pump (FPxxx) Feed pump is not working (OFF). It turns automatically off if
the low-level sensor detects a correct level (LSHxxx).

Circuit breaker has been triggered. Action is stopped,

problem must be analysed and fixed by qualified people.
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Component type Color Description

Circulation pump is working (ON). It gives a flow to the hot

water loop of the heating systems of the water jacket or the
vaporizer.

Heating skids Circulation pump is not working (OFF). It only turns off when
Circulation Pump the heating regulation is off.
(CPxxx)

Circuit breaker has been triggered. Action is stopped,

problem must be analysed and fixed by qualified people.

Circulation pump is working (ON). It gives a flow to the

scrubber stage.

Scrubber
Circulation pump is not working (OFF). It only turns off when
Circulation Pump
the scrubber stage is not used.
(CPxxx)

Circuit breaker has been triggered. Action is stopped,

problem must be analysed and fixed by qualified people.

Vacuum pump is working (ON). It extracts the air from the

sterilization chamber to reach the necessary vacuum
setpoint. Even if valves on the line are off, vacuum pumps can
be ON during to be preheated before to pull down vacuum or
the dry after used.

Vacuum Pump
(VPxxx) Vacuum pump is not working (OFF).

Circuit breaker has been triggered. Action is stopped,

problem must be analysed and fixed by qualified people.
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Component type Color Description

Recirculation fan is working (ON). It recirculates the air inside

the preconditioning/desorption room for the homogeneity.
Extraction fan is working (ON). It extracts the air from the
desorption room to the gas treatment.
Preconditioning &
desorption
Recirculation Fans Extraction fan is not working (OFF). It only turns off when the
(RCxxx) / desorption room is not used (off cycle).
Extraction Fans
(EFxxx)

Circuit breaker has been triggered. Action is stopped,

problem must be analysed and fixed by qualified people.

Extraction fan is working (ON). It put the scrubber in

depression. Air is extracted from the scrubber stages to the
roof.

Scrubber
Extraction fan is not working (OFF). It only turns off if none of
extraction fan
the scrubber stages are used.
(EFxxx)

Circuit breaker has been triggered. Action is stopped,

problem must be analysed and fixed by qualified people.

Electrical heater is working (ON). It heats up the water of the

water loop.

Electrical heater is not working (OFF). If the temperature

Electrical Heater
setpoint is reached, the electrical heater will regulate the
(EHxxx)
temperature by alternative switches ON/OFF.

Circuit breaker has been triggered. Action is stopped,

problem must be analysed and fixed by qualified people.

Pneumatic valve is opened (ON).

Pneumatic Valve
(PVxxx)
Pneumatic valve is closed (OFF).
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Component type Color Description

Flow switch is working (ON). Flow Switches can be placed on

water or air circuits (water jacket/vaporizer heating skids,
recirculation, preconditioning/desorption). They confirm the
Flow Switch Low
measured flow is enough.
(FSLxxx)
Flow switch is working (OFF). It can be because the there is no
flow, the flow is not enough, or the sensor is damaged.

Level Switches Low detect the minimum amount of liquid

required.
Level Switch Low
(LSLxxx)
Level Switches Low does not detect the minimum amount of
liquid required.

Level Switches High detect the maximum amount of liquid

required.
Level Switch High
(LSHxxx)
Level Switches High does not detect the maximum amount of
liquid required.

Pressure Switch
Maximum pressure allowed has been reached (ON).
High (PSHxxx)
EXCLUDING
PSH111 on the Under the maximum pressure allowed.
chamber

Chamber pressure is around 950mbar (atmospheric pressure)

Operating doors might be possible but injections are locked.
Chamber Pressure
Switch High
Chamber pressure is below 950mbar (under vacuum).
(PSH111)
Operating doors is not possible, but injection might be
allowed.

Minimum pressure needed has been reached (ON).

Pressure Switch
Low (PSLxxx)
Under minimum pressure required (OFF).

Zone Switch Open detect the final opened position

(ZSOxxx)
They are grey while the fully opened position is not reached.

Zone Switch Close detect the final closed position

(ZSCxxx)
They are grey while the fully closed position is not reached.
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Component type Color Description

PCB detect if an obstacle is on the way of moving system

(for example the doors). They are grey if they are ok.
(PCBxxx)
If they detect something, they will switch to red, stop the
moving equipment. If it is on the door, after a short stop
door will go back to the opposite way.

Analogue inputs are Pressure Transmitters (PTxxx),

Temperature Transmitters (TTxxx), Relative Humidity
Transmitters (RHTxxx), Weight Transmitters (WTxxx) and
Gas Transmitters (GTxxx). They are constantly displaying
Analogue inputs their instant value. They give “000” when the sensor if
(PTxxx, TTxxx, faulty.
RHTxxx, WTxxx,
GTxxx)
If an analogue input displays “XXX” it means the
communication between the transmitter and the controller
is stopped.

Heat exchangers got 2 separated circuits but with thermal

Heat Exchanger transmission. They are used to heat up or cool down a fluid
(Exxx) using another one. You can find them on heating systems,
vaporizer, gas treatments, etc.
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8. OPERATING MODES
The operating mode can be selected from the HMI by a specific user account. Two operating modes are possible: Automatic or
Manual. The switchover from one mode to the other is done through the maintenance page.

Automatic mode
In automatic mode, the operator can choose a recipe and start a cycle. The system will control all the actuators and sequences
in the different phases of the sterilization cycle until the cycle ends.
A recipe, also called sterilization profile, cycle profile, or parameters list is a determined set of cycle parameters that includes
rates, times, quantities, and setpoints that affect the sterilization process.
Be aware that only a specific user group can change the cycle parameters.
None of the actuators can be commanded on the automatic mode beside the opening/closing doors sequence at a specific step
(end of cycle, sterilizer in standby mode).

Manual mode
In manual mode, no sequences are performed. The system goes into a stopped state in which actuators (valves, pumps, motors,
electrical heaters etc.) can be activated through push buttons located in the HMI that appear only when this operation mode is
activated. A simple click on ON or OFF button is enough to action or stop the actuator. Only the doors buttons must be hold until
the position you would like to stop.

It is important to be qualified to use this mode as user can activate actuators and so potentially damage equipment or unsecure
the area.
This mode is useful to do some maintenance, get out of a cycle only in case of problems.
At switchover to manual mode during a cycle, all the PLC outputs are set to zero. For safety reasons:
• All the valves are closed, all the motors are stopped, and the door gaskets remain inflated.
• Some actions will be locked such as:
o Open steam or gas injection valve if the sterilization chamber is not under pressure
o Deflate gasket if the chamber is under vacuum.
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• The sterilization report will be stopped in this case.

At switchover from manual to automatic mode, PLC overtakes all commands to what the sterilizer is supposed to do. So, it is
important to previously manually put it back to standby conditions.
When the system come back in automatic mode two situation are possible
Some EtO has been inject, the system make automatically some rising in nitrogen and air before release the chamber
No EtO injected, the chamber is directly released.
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Operating mode switchover

To switchover the operating mode, you must be logged with a maintenance type of user. From the main page, go to Configuration
page

And select the operating mode you want separately for each equipment.
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9. OTHER PAGES
Toolbar
This toolbar gives access to others where it is possible to select the language, modify the system time and date, manage the user
accounts, calibrate the sensors, reset motor counters, switchover operating mode, etc.

Calibration page
This page shows every analog input which can be calibrated. To calibrate any sensor, you must enter the correct reference value
to the low point and press “Rec”. same thing with the high point. And Then press “Calibrate”. It is important to verify the
calibration has been done correctly (double check the values after calibration) and to save the updated Span and Zero values.

If the calibration failed, we suggest to reset Zero and Span values and do again the complete process.

Motor hours page

This page gives to the maintenance team the running hours done by important motors to help for preventive maintenance.
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Alarm page
This page shows the current alarms and the previous one which have not been deleted. You can acknowledge the alarm from
this page and access to the alarm history.

Alarm history page

This page shows every alarms and track when they happened, have been solved and deleted.
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Curves page
Analogue curves are displayed on a chart (pressure, temperature, humidity, weight, gas transmitters). It is possible to zoom on
the chart and place an indicator which give the exact value of every transmitter at a certain time. It is very useful tool to diagnose
what could happen during a cycle.

EO bottles setup page

Two EO bottles are connected to the vaporizer. If one bottle is empty, the sterilizer will trigger an alarm level 1 to inform the
operator to replace it and automatically switch over to the other line.
It is better to replace the empty bottle when the sterilizer is off cycle, so it does not affect the weight transmitted by the scale.
If the second line is empty, the sterilizer will trigger the same alarm for this second line and also a third alarm to inform the
operator the lack of EO, pause the cycle and wait. The operator must replace the bottles and acknowledge the alarm.
When the sterilizer is paused, it decreases its temperature regulation, recirculation flows etc. So it is important to solve the
problem as fast as possible.
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Recipes management page

On this page, it is possible to adjust every cycle parameters such as Pressure, Temperature, Humidity, Time setpoints.

A viewer page is accessible to anyone but modification is not allowed if not logged in with a correct user account. Recipes can
be printed or save as PDF. We highly recommend to keep a copy after every modification or creation of a new recipe.

Report management pages

On this page you can find every cycle performed. Reports are split in 3 documents: General report, Alarm report and Summary
report.
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Sterilization page (cycle launcher)

Accessible only to qualified staff (operators), with this page you can specify all the characteristics of the sterilization batch
including its number, type of cycle, description, etc., before to start it. It is important to correctly fulfill every information.
It displays the needed conditions to be authorized to start the cycle with grey (not ok) /green (ok) lights. Cycle can only start if
all the conditions are ok, cycle recipe selected, batch number and observation fulfilled.

After the cycle has started, this page will display the previously fulfilled information the status of the cycle and the graphic chart
showing the most important analogic sensors (pressure, temperature, humidity transmitters).

Pre-conditioning / Desorption pages (cycle launcher)

Those pages are similar to the Sterilization cycle launcher page but less conditions are required.
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10. STERILIZATION CYCLES MANAGEMENT

Daily routine checks
The sterilization installation required attention by every user. Operators must daily check the following points:

In the control room:

• Electrical cabinet is supplied, all voltages lights are ON (400Vac, 230Vac, 24Vdc).
• UPS (optional) are ON (230Vac for the computer, 24Vdc for the PLC).
• HMI and printer are ON.
• No occurring alarm.
• Compressed air supply is ok (>6bar given by PSL14).
• Main Nitrogen supply is ok (given by PSL301).
• Water jacket at temperature (given by TT131 but depends of the cycle parameters).
• Make sure the EO bottles information are correctly fulfilled before to start the cycle.

On the chamber
• The water jacket pressure is ok (1,5 to 2bars given by PI201).
• Nitrogen supply to the gasket is ok (from 2 to 2,5 bar given by PSL15).
• Hot water loop manual valves are opened (if used).

On the vaporizer heating skid

• The water loop pressure is ok (1,5 to 2bars given by PI401).
• Air supply to the pneumatic components is ok (from 5 to 7bar given by PSL14).
• Hot water loop manual valves are opened (if used).

On the vacuum pumps

• Verify the hand valves positions:
o opened from the sterilizer outlet to the vacuum pumps inlet.
o opened to the vacuum pumps outlet to the gas treatment or the roof).
• Check oil level of every vacuum pumps. Refilled as required.
• Empty every condensate tank.

On the vaporizer
• Verify the hand valves positions:
o Opened from the bottles to the sterilizer (Bottle taps, HV301, HV302, HV303, HV304 for example) Closed for the
nitrogen flush valves (HV307, HV308 for example).
• Water pressure is ok (1,5 to 2bars given by PI401).
• Hot water loop manual valves are opened.
• The EO supply pressure: the addition of both EO lines must be above a certain amount, value can depend, sterilisation
chamber size and the cycle parameters (PI301 + PI302).
• EO bottles are on the scale.
• Make sure the EO bottles information are correctly fulfilled before to start the cycle.
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Start sterilization cycle

Before to start the cycle, the operator must do the checks mentioned in Daily routine checks.
The pallets of products must be properly loaded inside the sterilization chamber. It is important to let the gas circulates in the
complete volume to be homogeneous in temperature, humidity and gas concentration. The pallets must not touch the internal
wall of the chamber and be separate from each other by 10cm on every side. If your sterilizer is equipped by a mobile probe,
you should place it in the middle of the pallet which is in the middle of the sterilisation chamber.
When everything is ok. You can:
• Make sure it is safe to close the door (no obstacle, nobody inside).
• Go back to the control room.
• Log in to the HMI.
• Go to the process page or use the dedicated door screen and close the loading door.
• Go back to the Home page to go to the Sterilisation page (cycle launcher).
• Select the cycle recipe you want and fulfilled information (Batch number and observation).
• Now you can start the cycle. The page will change for the in-progress cycle with curves.
• While performing a cycle, it is important to pay attention of the process and keep attention to potential alarms.

Stop sterilization cycle

At the end of the cycle the sterilizer will wait the confirmation of the operator to go back to atmospheric pressure. The operator
must go back to the in-progress cycle page confirm by a click on “End of cycle”.

Cancel sterilization cycle

Before the end of the cycle, the operator can decide to cancel the cycle. To do it, the operator must go back to the in-progress
cycle page and click on “Cancellation”. Cancellation behaviour depends of the step of the cycle. The different behaviours are
described in the chapter Cycle cancellation .
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11. BASIC MAINTENANCE

Preventive maintenance plan
Here after is a basic preventive maintenance plan. This might need adjustment according to the client use (frequency of cycles,
product types, environment, etc.). Maintenance must be performed by qualified people considering potential risks.
6
Family Description Daily Weekly Monthly Yearly
months
Water pressure of the vaporizer heating skid
loop: 1bar when cold / 2bar when hot X

Water pressure of the chamber heating skid

loop: 1bar when cold / 2bar when hot X

Compressed air supply: 6-8bar X

Supplies Nitrogen supply to the gaskets: 1,5-2bar X
Nitrogen supply to the vaporizer: PSL ON X
Nitrogen quality: >95% X
Enough EO: at least one bottle full before to
X
start any cycle
Emptying the vacuum pumps condensate pots X
Vacuum pumps oil level X
Potential damaged on mobile probes
(Temperature Transmitters inside chamber) X

Inflatable gaskets not damaged, well placed

inside its groove and sticked X
Visual Polymerisation (injections deflectors, vacuum
inspections X
pump cartridge, etc.)
Potential damaged on every equipment X
Pneumatic leakage (chamber and vaporizer
X
pneumatic cabinets)
Safety valve within date and no leak X
Scrubber levels X
230Vac and 24Vdc UPS working properly X
Intensity measurements on high power
Electrical
equipment such as motors but especially the X
checks
Electrical Heaters (EHxxx) (correct and even)
Tightness check of the high voltage terminals X
Air vacuum break inlet filter X
Air vacuum break inlet pre-filter X
Nitrogen supply inlet filter X
Steam traps X
Parts Recirculation mechanical seal X
replacement
Recirculation carbon brushes X
Vacuum pump oil X
Vacuum pump air inlet filter X
Vacuum pump exhaust filter X
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6
Family Description Daily Weekly Monthly Yearly
months
Automatic air purges on water loops X
Manual purges on water jacket X
Electrical Breakers (LUB32 type) Every 2
years
Steam generator seal X
General cleaning to be adjusted to the
equipment environment (motors, fans, rails, X
doors actuators, etc.)
Deflectors X
EO inlet strainers X
Cleaning EO injection line with steam using MDS
X
maintenance kit
Automatic air vents X
Empty the scrubber and renew water + acid X
Electrical cabinet in/outlet filters X
Descale the steam generator X
Perform vacuum tests (vacuum and injections
X
rates + long leak test)
Aeration flow measurements (recirculation,
X
extractions)
Performances Calibration checks and adjustments, if
necessary, for every:
Pressure Transmitters (PT), Temperature X
Transmitters (TT), Relative Humidity
Transmitters (RHT), Weight Transmitters (WT)
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Advised spare parts

To avoid to lose any time of production, we suggest to keep at all time the following parts in case of emergency:
Description Qty
Sterlizer
Electrical Heater (EHxxx) 2
Air vacuum break inlet filter (F151) 1
Air vacuum break inlet pre-filter 1
Nitrogen supply inlet filter (F301) 1
Steam traps (STxxx) 2
Recirculation mechanical seal 1
Recirculation carbon brushes 2
Vacuum pump oil (level adjustment) X
Vacuum pump air inlet filter (F50x) 1
Automatic air purges on water loops 2
Electrical breaker (LUB32 type) 2
Water loop flow switch (FSL201/401) 1
Recirculation flow switch (FSL121) 1
Relative humidity transmitter (RHT/TT121) 1
Mobile probe (TT111) 1
Pressure Transmitter (PTxxx) 1
Door gaskets (IGxxx) 2
Bottle gaskets 2
Non-ATEX Temperature Transmitter (TTxxx) 1
ATEX Temperature Transmitter (TTxxx) 1
Cleaning kit 1
Stainless steel cleaning spray 1
Complete recirculation system 1
Steam generator
Level switch (LSL/LSHxxx) 1
Electrical heater (EHxxx) 1
Electrical breaker (LUB32 type) 1
Vessel gasket 1
Preconditioning
Steam traps 1
Pneumatic valve (PV90x) 1
Scrubber
Level switch (LSL/LSC/LSHxxx) 1
ATEX Temperature Transmitter (TTxxx) 1
Pressure Transmitter (PT711)
Safety pack
Gas mask filter cartridge 10
Mask 1
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Additional maintenance information

For maintenance or test purposes, some spare connections are available on the top of the sterilizer. Various type can be present
such as: female ½” gas, female ¾” gas, ½” clamp or 2” clamp. Every of them are blocked and sealed by leads but can be used to
connect instruments. Any connection of instrument has to be done off cycle and at atmospheric pressure.

Door gasket replacement

Door gaskets are inflated with nitrogen at a lower pressure than the supply (adjusted to 1,5bar by PRV15 in the pneumatic
cabinet of the water jacket heating skid). An integrity test is performed at the start of the cycle. It might detect a leak of the
gasket. Make sure the pneumatic connections were good before to replace a door gasket.
If you need to replace it, proceed as below:
• Make sure there is no pressure inside the gasket (PSL10 for the loading door, PSL12 for the unloading door). Close the
nitrogen supply valve in the pneumatic cabinet.
• Use the manual mode to open the door.
• Disconnect the gasket from the pneumatic hose (usually located in on the top of the chamber next to the gasket on a
specific box).
• Pull out the gasket from its groove.
• Clean the groove.
• Place a few specific glue drops inside the groove (temperature resistant and suitable with EO)
• Insert the valve of the new gasket.
• Place the new gasket in the groove starting by the corners and push it everywhere.
• Close the door.

EO bottle replacement
There are 2 EO lines on the vaporizer to connect 2 EO bottles. During any cycle, if one bottle is empty, the PLC will detect it
because the pressure will not increase as fast as it is supposed to do. So, it will automatically inform the operator with an alarm
level 1, close the actual EO line, use the second one and continue the cycle. If the second line is empty too, it will inform the
second line is empty by a level 1 alarm but also pause the cycle with a lack of EO alarm level 2.
Before to start any cycle, you must verify if the correct amount of EO is available.
If necessary, proceed to the replacement of the empty bottle using the following steps (tags given as example to replace Bottle
1 on first vaporizer. Please refer to the PID to replace another bottle):
• Make sure you are warned and qualified to proceed to the EO bottle replacement
• Wear the proper PPE (Personal Protection Equipment) such as long sleeves and gloves, filtered mask, eye protection,
etc. Make sure to use proper tools (explosion proof).
• Verify the manual valves from the bottles to the vaporizer are opened (Bottle taps, HV301, HV302, HV303, HV304 for
example)
• Verify the pressure on the EO line manometer PI301 (bottle is empty).
• Make sure you have nitrogen supply.
• Open the manual flush valve HV307 for a few second to push the EO residual to the bottle.
• Close the bottle tap.
• Close the flush valve HV307 and the inlet valve HV301.
• Unscrew the bottle connection to the flexible (watch out: reversed screw connection). Make sur the gasket stays on the
flexible. Verify if it is not damaged. Replace it if necessary.
• Remove de grounding tongue and identify the bottle as “empty” and put it away to the specific empty bottles place.
• Put the new bottle on the scale, remove the protection and leads. Collect the identification and information of the
bottle.
• Put back the grounding tongue and reconnect the flexible on the bottle. Make sure the gasket is good and back in
position.
• Open the manual flush valve HV307 to check there is no leak and close it back.
• Carefully open the bottle tap and check if the connection is not leaking.
• Carefully open the inlet valve HV301.
• Verify the EO pressure one the manometer PI301.
• Go to the HMI and fulfil the information of the new bottle (Serial number, Batch Number, Maximum date of use, etc.)
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ANNEXES
For a better knowledge of your installation, in addition to this manual, please refer to:
• Hardware design: description of the controlling equipment.
• Software design: description of the software and protocols used.
• Risks Assessment: risks description.
• Functional analysis: functions description of the installation.
• Alarms list: list of alarms and troubleshooting for maintenance.
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12. ANNEX I - LIST OF ALARMS DISPLAYED ON THE HMI

Alarm
TAG Element Description Alarm message Activation Triggering action
level

Sterilizer

Analogue input value -

AL_0 PT 112 Chamber pressure sensor fault AL0 - PT112 sensor failure Permanent 32768 1
Wire cut
Analogue input value -
AL_1 PT 111 Chamber pressure sensor fault AL1 - PT111 sensor failure Permanent 32768 2
Wire cut
Analogue input value -
Chamber injection temperature 32768
AL_2 TT 191 AL2 - TT191 sensor failure Permanent 1
sensor fault
Wire cut
Analogue input value -
Recirculation temperature 32768
AL_3 TT 123 AL3 - TT123 sensor failure Permanent 2
sensor fault
Wire cut
Analogue input value -
Water jacket temperature 32768
AL_4 TT 131 AL4 - TT131 sensor failure Permanent 2
sensor fault
Wire cut
Analogue input value -
32768
Chamber mobile temperature
AL_5 TT 111 AL5 - TT111 sensor failure Permanent 2
sensor fault Wire cut
Wire cut
Analogue input value -
AL_7 TT 121 Recirculation motor sensor fault AL7 - TT121 sensor failure Permanent 32768 2
Wire cut
Analogue input value -
AL8 - RHT121 sensor 32768
AL_8 RHT 121 Chamber humidity sensor fault Permanent 2
failure
Wire cut
Analogue input value -
Steam generator pressure 32768
AL_9 PT 601 AL9 - PT601 sensor failure Permanent 0
sensor fault
Wire cut
Analogue input value-
Scrubber temperature sensor 32768
AL_10 TT 711 AL10 - TT711 sensor failure Permanent 0
fault
Wire cut
Analogue input value-
AL11 - PT711 sensor 32768
AL_11 PT 711 Scrubber pressure sensor fault Permanent 0
failure
Wire cut
Vaporizer skid : cold water AL12 – TT402 sensor Analogue input value -
AL_12 TT 402 Permanent 2
temperature failure 32768
 Ref: HH-EO_User
EO STERILIZER Manual_Rev4
Author: GP
Creation date
15/10/2020
Revision date
04/08/2022
USER MANUAL Page 43 on 62

Alarm
TAG Element Description Alarm message Activation Triggering action
level

Wire cut
Analogue input value-
Vaporizer skid: hot water AL13 – TT401 sensor 32768
AL_13 TT 401 Permanent 2
produced temperature failure
Wire cut
Analogue input value-
Desorption B temperature AL14 – TT951B sensor 32768
AL_14 TT 951 B Permanent 0
sensor fault failure
Wire cut
Analogue input value-
Desorption B temperature AL15 – TT952 B sensor 32768
AL_15 TT 952 B Permanent 0
sensor fault failure
Wire cut
Analogue input value-
Vaporizer EtO Weight AL16 - WT301 sensor 32768
AL_16 WT 301 Permanent 2
Transmitter failure
Wire cut

Analogue input value-

Desorption B temperature AL17 -TT953B sensor 62768
AL_17 TT 953 B Permanent 0
sensor fault failure
Wire cut
Analogue input value-
Chamber temperature sensor AL18 – TT112 sensor 32768
AL_18 TT 112 Permanent 1
fault failure
Wire cut
Analogue input value -
Water jacket heating skid: hot 32768
AL_22 TT 201 AL22 - TT201 sensor failure Permanent 2
water produced temperature
Wire cut

Analogue input value -

Vacuum pump temperature AL23 – TT511 sensor 32768
AL_23 TT 511 Permanent 2
transmitter failure
Wire cut
Analogue input value -
Vacuum pump Temperature 32768
AL_24 TT 501 AL24 - TT501 sensor failure Permanent 2
transmitter
Wire cut
Analogue input value -
Desorption A temperature AL25 – TT951 A sensor 32768
AL_25 TT 951 A Permanent 0
sensor fault failure
Wire cut
Analogue input value –
Desorption A temperature AL26- TT952A sensor 32768
AL_26 TT 952 A Permanent 0
sensor fault failure
Wire cut
Analogue input value –
Desorption A temperature AL27 – TT953 A sensor 32768
AL_27 TT 953 A Permanent 0
sensor fault failure
Wire cut
Analogue input value -
Preconditionnement A AL29-TT901 A sensor 32768
AL_29 TT 901 A Permanent 0
temperature sensor fault failure
Wire cut
 Ref: HH-EO_User
EO STERILIZER Manual_Rev4
Author: GP
Creation date
15/10/2020
Revision date
04/08/2022
USER MANUAL Page 44 on 62

Alarm
TAG Element Description Alarm message Activation Triggering action
level

Analogue input value -

Preconditionnement A humidity AL30-RHT902 A sensor 32768
AL_30 RHT 902 A Permanent 0
sensor fault failure
Wire cut
Analogue input value –
Preconditionnement A AL32 – TT902 A sensor 32768
AL_32 TT 902 A Permanent 0
temperature sensor fault failure
Wire cut
Analogue input value –
Preconditionnement A humidity AL33 – RHT903 A sensor 32768
AL_33 RHT 903 A Permanent 0
sensor fault failure
Wire cut
Analogue input value –
Preconditionnement A AL34 – TT903 A sensor 32768
AL_34 TT 903 A Permanent 0
temperature sensor fault failure
Wire cut
Analogue input value –
Preconditionnement B AL35 – TT901 B sensor 32768
AL_35 TT 901 B Permanent 0
temperature sensor fault failure
Wire cut
Analogue input value –
Preconditionnement B humidity AL36 – RHT902 B sensor 32768
AL_36 RHT 902 B Permanent 0
sensor fault failure
Wire cut
Analogue input value –
Preconditionnement B AL37 – TT902 B sensor 32768
AL_37 TT 902 B Permanent 0
temperature sensor fault failure
Wire cut
Analogue input value –
Preconditionnement B humidity AL38 – RHT903 B sensor 32768
AL_38 RHT 903 B Permanent 0
sensor fault failure
Wire cut
Analogue input value –
Preconditionnement B AL39 – TT903 B sensor 32768
AL_39 TT 903 B Permanent 0
temperature sensor fault failure
Wire cut
Definition of a maximum
Chamber recirculation critical AL41 - Recirculation fan temperature
AL_40 TT 121 Permanent 3
temperature 121 critical temperature
(RC Max temperature)
Definition of a maximum
Chamber recirculation critical AL41 - Recirculation fan temperature
AL_41 TT 122 Permanent 3
temperature 121 critical temperature
(RC Max temperature)
Definition of a maximum
Chamber recirculation over- AL41 - Recirculation fan temperature
AL_42 TT 121 Permanent 1
temperature 121 over temperature
(RC Max temperature_2)
Definition of a maximum
Chamber recirculation over- AL41 - Recirculation fan temperature
AL_43 TT 122 Permanent 1
temperature 121 overtemperature
(RC Max temperature_2)
 Ref: HH-EO_User
EO STERILIZER Manual_Rev4
Author: GP
Creation date
15/10/2020
Revision date
04/08/2022
USER MANUAL Page 45 on 62

Alarm
TAG Element Description Alarm message Activation Triggering action
level

During
exposure time, FSL121 sensor triggered +
Chamber first recirculation low AL50 – Chamber first
AL_50 FSL 121 preconditionin sterilizer time setup 2
flow recirculation low flow
g and before (SC_M_StartTime)
first vacuum
During
exposure time, FSL122 sensor triggered +
Chamber second recirculation AL51 – Chamber second
AL_51 FSL 122 preconditionin sterilizer time setup 2
low flow recirculation low flow
g and before (SC_M_StartTime)
first vacuum
If cylinder #1 selected and
During EtO the pressure increase is
AL55 - EtO Cylinder 1
AL_55 EtO1 EtO1 cylinder empty injection lower than the setup value 1
empty
phases (GI_MinDrumPressIncreas
e)
If cylinder #2 selected and
During EtO the pressure increase is
AL56 - EtO Cylinder 2
AL_56 EtO2 EtO2 cylinder empty injection lower than the setup value 1
empty
phases (GI_MinDrumPressIncreas
e)

During EtO
No ethylene oxide (both
AL_57 EtO1, EtO2 AL57 - Lack of EtO injection AL_55 and AL_56 active 2
cylinders empty)
phases

Vaporizer skid nitrogen low AL58 - Vaporizer skid

AL_58 PSL 301 Permanent PSL301 sensor triggered 2
pressure nitrogen low pressure
TT181<=GI_MinEOChambe
rTemp
EtO injection temperature out of AL59 - EtO injection During EtO
AL_59 TT 191 or 2
range temperature out of range injection steps
TT181>=GI_MaxChamberT
emp

Vaporizer heating skid low AL69 - Hot water vaporizer During skid
AL_69 FSL 401 FSL401 sensor triggered 2
circulation loop low flow operation

Vaporizer heating skid low AL70 – Vaporizer heating During skid

AL_70 PSL 401 PSL401 sensor triggered 1
pressure skid low pressure operation

AL71 - Steam generator

Dft_EH 601 Steam generator electrical Circuit breaker electrical
AL_71 electrical heater electrical Permanent 1
Dft_EH 602 heater electrical failure contact on the digital input
failure

AL72 - Steam generator

Steam generator filling pump Circuit breaker electrical
AL_72 Dft_FP 601 filling pump electrical Permanent 1
electrical failure contact on the digital input
failure

AL73 - Steam generator

AL_73 LSL 601 Steam generator low level Permanent LSL601 sensor triggered 1
very low level
 Ref: HH-EO_User
EO STERILIZER Manual_Rev4
Author: GP
Creation date
15/10/2020
Revision date
04/08/2022
USER MANUAL Page 46 on 62

Alarm
TAG Element Description Alarm message Activation Triggering action
level

AL74 – Steam generator

AL_74 PSH 601 Steam generator overpressure Permanent PSH601 sensor triggered 0
over pressure

Loss of FSL201 contact +

AL77 - Water jacket
During skid sterilizer time setup
AL_77 FSL 201 Hot water jacket loop flow loss heating skid low 2
operation (WJ_CirculationTime)
circulation
during C201 operation
Water jacket heating skid low AL78 – Water jacket During skid
AL_78 PSL 201 PSL201 sensor triggered 1
pressure heating skid low pressure operation
Nitrogen pressure in electric AL79 - Electrical cabinet
AL_79 PSL 15 Permanent PSL15 sensor triggered 2
power supply cabinet low nitrogen low pressure
Compressed air pressure in AL80 - Electrical cabinet
AL_80 PSL 14 electric power supply cabinet compressed air low Permanent PSL14 sensor triggered 2
low pressure
Emergency stop activated
AL_81 ESR Emergency shutdown engaged AL81 - Emergency stop Permanent 2
in electrical cabinet

Dft_VP 501 Vacuum pump electrical circuit AL89 - vacuum pump Circuit breaker electrical
AL_89 Permanent 4
Dft_VP 511 breaker fault electrical failure contact on the digital input

AL90 – Vacuum pump 501

Isolation
AL_90 Vacuum pump 501 isolation has been isolate by the Permanent VP501 Manual isolation 1
VP 501
user
AL91 – Vacuum pump 501
Isolation
AL_91 Vacuum pump 511 isolation has been isolate by the Permanent VP511 Manual isolation 1
VP 511
user

Re-circulation fan electrical AL92 - Recirculation fan Circuit breaker electrical

AL_92 Dft_RC 121 Permanent 2
circuit breaker fault electrical failure contact on the digital input

Dft_BV 161 Extraction fan electrical circuit AL93 - Extraction fan Circuit breaker electrical
AL_93 Permanent 1
Dft_BV 162 breaker fault electrical failure contact on the digital input

Vaporizer electrical heater AL97 - Vaporizer electrical Circuit breaker electrical

AL_97 Dft_EH 401 Permanent 2
electrical circuit breaker fault heater electrical failure contact on the digital input

AL99 - Vaporizer
Vaporizer circulation pump Circuit breaker electrical
AL_99 Dft_CP 401 circulation pump electrical Permanent 2
electrical circuit breaker fault contact on the digital input
failure
AL104 - Water jacket
Water Jacket circulation pump Circuit breaker electrical
AL_104 Dft_CP 201 circulation pump electrical Permanent 2
electrical circuit breaker fault contact on the digital input
failure
AL105 - Water jacket
Water Jacket electrical heater Circuit breaker electrical
AL_105 Dft_EH 201 electrical heater electrical Permanent 2
circuit breaker fault contact on the digital input
failure
Operating time for back venting AL122 -Back venting 162
AL_122 BV162 Permanent Expired time 0
maintenance expired maintenance necessary
Operating time for back venting AL123 -Back venting 161
AL_123 BV161 Permanent Expired time 0
maintenance expired maintenance necessary
 Ref: HH-EO_User
EO STERILIZER Manual_Rev4
Author: GP
Creation date
15/10/2020
Revision date
04/08/2022
USER MANUAL Page 47 on 62

Alarm
TAG Element Description Alarm message Activation Triggering action
level

Operating time for electrical AL124 -Steam generator

AL_124 EH602 heater from steam generator electrical heater 602 Permanent Expired time 0
maintenance expired maintenance necessary
Operating time for electrical AL125 -Steam generator
AL_125 EH601 heater from steam generator electrical heater 601 Permanent Expired time 0
maintenance expired maintenance necessary
Operating time for steam AL126 -Steam generator
AL_126 FP601 generator filling pump filling pump maintenance Permanent Expired time 0
maintenance expired necessary
Operating time for Vaporizer AL127 – Vaporizer
AL_127 CP401 circulation pump maintenance circulation pump Permanent Expired time 0
expired maintenance necessary
Operating time for Vaporizer AL128 – Vaporizer
AL_128 EH401 electrical heater maintenance electrical heater Permanent Expired time 0
expired maintenance necessary
Operating time for water jacket AL129 – Water jacket
AL_129 CP201 circulation pump maintenance circulation pump Permanent Expired time 0
expired maintenance necessary
Operating time for water jacker AL130 – Water jacket
AL_130 EH201 electrical heater maintenance electrical heater EH201 Permanent Expired time 0
expired maintenance necessary
Operating time for water jacket AL131 – Water jacket
AL_131 EH202 electrical heater maintenance electrical heater EH202 Permanent Expired time 0
expired maintenance necessary
AL132 - Recirculation fan
Operating time for re-circulation
AL_132 RC 122 122 maintenance Permanent Expired time 0
fan maintenance expired
necessary
Operating time for vacuum AL133 - Vacuum Pump 511
AL_133 VP 511 Permanent Expired time 0
pump maintenance expired maintenance necessary
Operating time for vacuum AL134 - Vacuum Pump 501
AL_134 VP 501 Permanent Expired time 0
pump maintenance expired maintenance necessary
AL135 - Recirculation fan
Operating time for re-circulation
AL_135 RC 121 121 maintenance Permanent Expired time 0
fan maintenance expired
necessary
Definition of a maximum
During Water
time to reach temperature
AL145 - Water jacket jacket
AL_145 NA Water Jacket heating too long for the jacket in PLC 1
heating too long temperature
(WJ_TemporizedOpenTim
rise steps
e)

Definition of a maximum
During
AL149 - Vaporizer time to increase the
AL_149 NA Vaporizer heating too long vaporizer 1
temperature rise too long temperature
heating
(VH_HeatingMaxTime)

Definition of a maximum
AL162 - Door adjusting During door open/close time in
AL_162 NA Door adjusting time out 2
time out movement autoclave setup
(DG_DoorMaxTime)
 Ref: HH-EO_User
EO STERILIZER Manual_Rev4
Author: GP
Creation date
15/10/2020
Revision date
04/08/2022
USER MANUAL Page 48 on 62

Alarm
TAG Element Description Alarm message Activation Triggering action
level

AL169 - Steam generator

AL_169 NA Steam generator filling too long Permanent Pump running time > 60s 1
filling too long

AL200 – PM Quality Loss connection with PM-

AL-200 NA PM Quality connection failure Permanent 1
connection failure Quality

Definition of a maximum
Vacuum pump temperature too AL232 - Vacuum pump temperature in the
AL_232 TT 501 Permanent 4
high temperature too high sterilizer setup parameters
(VP_MaxTemperature_L)
Definition of a maximum
AL233 – Second vacuum
Second vacuum pump temperature in the
AL_233 TT 511 pump temperature too Permanent 4
temperature too high sterilizer setup parameters
high
(VP_MaxTemperature_L)

AL234 - Vacuum pump Pressure switch signal is

AL_234 PSH 501 Vacuum pump over pressure Permanent 4
over pressure triggered

Second vacuum pump over AL235 – Second vacuum Pressure switch signal is
AL_235 PSH 511 Permanent 4
pressure pump over pressure triggered

Definition of a minimum
value to compare the
AL238 - Vacuum speed too During vacuum
AL_238 PT 111 Vacuum fault increase of pressure 1
low steps
(logarithmic)
(VP_TimeConst)
Definition of the maximum
AL250 - Vaporizer high temperature in cycle
AL_250 TT 401 Vaporizer high temperature In cycle 2
temperature parameter in autoclave
setup (VH_OverTemp)
Definition of a setpoint
temperature and
Water Jacket temperature out of AL256 - Water jacket tolerances in PLC
AL_256 TT 131 In cycle 1
range temperature out of range (WJ_InfTol,
WJ_SupTol+TimerWJ_Tem
pAlarmTimer
Authorized leakage cycle
AL262 - Leak on chamber parameter in high pressure
AL_262 NA Chamber sealing fault In cycle 3
during leak test leak test exceeded (T032,
T052)

AL263 - Maximum Definition of a maximum

During
AL_263 PT 111 Chamber pressure too high pressure increase detected pressure setpoint in 3
exposure
during exposure time autoclave setup (DP154)
 Ref: HH-EO_User
EO STERILIZER Manual_Rev4
Author: GP
Creation date
15/10/2020
Revision date
04/08/2022
USER MANUAL Page 49 on 62

Alarm
TAG Element Description Alarm message Activation Triggering action
level

During
Definition of a maximum
AL264 - Chamber pressure chamber
AL_264 PT 111 Chamber pressure rise too long pressure rise time in 1
rise too long pressure rise
autoclave setup
steps
Definition of a maximum
A significant pressure difference pressure difference
PT 111 / AL273 - Chamber pressure
AL_273 appears between the chamber Permanent between the 2 sensors in 2
PT 112 sensor discordance
pressure sensors autoclave setup
(PT_MaxDiff)
AL275 - Automatic
Automatic controller powered or Automatic controller start-
AL_275 PLC controller powered or re- Permanent 1
re-started (electrical cabinet) up
started
Cycle cancellation requested by AL276 - Cancelling in
AL_276 NA In cycle Cancellation from the HMI 3
operator (from the HMI) progress

AL277 - Electrical cabinet R201 power supply relay

AL_277 R 201 Loss of general power supply Permanent 2
power failure contact detected

Doors

AL_11-01 Loading door

AL_11-01 PSL 10 Loading door gasket leak Permanent Loss PSL10 sensor 3
gasket leak

AL_11-02 Unloading door

AL_11-02 PSL 12 Unloading door gasket leak Permanent Loss PSL12 sensor 3
gasket leak

Loading door gasket inflating too AL_11-03 Loading door Time out on gasket
AL_11-03 NA Permanent 0
long gasket inflating too long positioning

Unloading door gasket inflating AL_11-04 Unloading door Time out on gasket
AL_11-04 NA Permanent 0
too long gasket inflating too long positioning

Loading door gasket deflating AL_11-05 Loading door Time out on gasket
AL_11-05 NA Permanent 0
too long gasket deflating too long positioning

Unloading door gasket deflating AL_11-06 Unloading door Time out on gasket
AL_11-06 NA Permanent 0
too long gasket deflating too long positioning

Loading door Obstacle during AL_10-01 Loading door

AL_10-01 PCB 172 Permanent PCB172 sensor triggered 0
closing Obstacle during closing

Loading door Obstacle during AL_10-02 Loading door

AL_10-02 PCB 171 Permanent PCB171 sensor triggered 0
opening Obstacle during opening

Unloading door Obstacle during AL_10-03 Unloading door

AL_10-03 PCB 181 Permanent PCB181 sensor triggered 0
closing Obstacle during closing

Unloading door Obstacle during AL_10-04 Unloading door

AL_10-04 PCB 182 Permanent PCB182 sensor triggered 0
opening Obstacle during opening

AL_10-05 Loading door Waiting time for the door

AL_10-05 NA Loading door opening too long Permanent 0
opening too long to close

AL_10-06 Loading door Waiting time for the door

AL_10-06 NA Loading door closing too long Permanent 0
closing too long to close
 Ref: HH-EO_User
EO STERILIZER Manual_Rev4
Author: GP
Creation date
15/10/2020
Revision date
04/08/2022
USER MANUAL Page 50 on 62

Alarm
TAG Element Description Alarm message Activation Triggering action
level

Unloading door opening too AL_10-07 Unloading door Waiting time for the door
AL_10-07 NA
long opening too long Permanent to close 0

Unloading door opening too AL_10-08 Unloading door Waiting time for the door
AL_10-08 NA
long opening too long Permanent to close 0

Scrubber

AL_7-03 Scrubber
Scrubber extraction fan Circuit breaker electrical
AL_7-03 DFT EF 721 extraction fan electrical Permanent 0
electrical failure contact on the digital input
failure
AL_7-04 Scrubber first
Scrubber first stage pump Circuit breaker electrical
AL_7-04 DFT CP 711 stage pump electrical Permanent 0
electrical failure contact on the digital input
failure
AL_7-05 Scrubber second
Scrubber second stage pump Circuit breaker electrical
AL_7-05 DFT CP 721 stage pump electrical Permanent 0
electrical failure contact on the digital input
failure

AL_7-08 Scrubber level

AL_7-08 NA Scrubber level discordance Permanent Scrubber level discordance 0
discordance

Definition of the maximum

AL_7-10 Srcubber first
Srcubber first stage temperature temperature in cycle
AL_7-10 NA stage temperature too Permanent 0
too high parameter in autoclave
high
setup

AL_7-12 Scrubber first

AL_7-12 LSL 711 Scrubber first stage low level Permanent LSL711 sensor triggered 0
stage low level

AL_7-14 Scrubber first

AL_7-14 LSH 711 Scrubber first stage high level LSH711 sensor triggered 0
stage high level Permanent

AL_7-16 Scrubber first LSC711 Scrubber first

AL_7-16 FSL 711 Scrubber first stage low flow 0
stage low flow Permanent stage low flow

AL_7-18 Scrubber over Pressure switch signal is

AL_7-18 NA Scrubber over pressure 0
pressure Permanent triggered

AL_7-19 Additional tank

AL_7-19 LSH 701 Additional tank full LSH701 sensor triggered 0
full Permanent

LSH 701 AL_7-21 Scrubber draining LSH701 & LSH711 sensor

AL_7-21 Scrubber draining necessary 0
LSH 711 necessary Permanent triggered

AL_7-23 Scrubber level Scrubber second level

AL_7-23 NA Scrubber level discordance Permanent 0
discordance discordance
 Ref: HH-EO_User
EO STERILIZER Manual_Rev4
Author: GP
Creation date
15/10/2020
Revision date
04/08/2022
USER MANUAL Page 51 on 62

13. ANNEX II – CYCLE PARAMETERS FOR CYCLE RECIPE CREATION

These are the process parameters. They are only accessible to qualified site personnel and enable adjustment of the sterilized
product process.
Parameter name
Description Units
(tag)
Temp001 Chamber temperature °C
M001 Estimated injected EO weight kg
T001 Cycle estimated remaining time min
DTemp001 Delta temp for maximum alarm set point during exposure time °C
DTemp002 Delta temp for minimum alarm set point during exposure time °C
Preconditioning mode control :
0 : NO humidity control
MC011 1 : Humidity control with humidity set point ---
2 : Humidity control with maximum pressure
3 : Preconditioning out of the sterilizer
T011 Preconditioning time min
RH011 Preconditioning humidity setpoint %RH
R011 Steam injection rate mbar/min
V011 Preconditioning limit pressure mbar abs
Temp011 Preconditioning temperature °C
R021 Vacuum rate mbar/min
V021 Vacuum pressure setpoint mbar mbar abs
T031 Low pressure stabilization time min
T032 Low pressure leak test time min
DP031 Maximum pressure leak mbar
R041 Nitrogen injection rate mbar/min
V041 Nitrogen injection setpoint mbar abs
T051 High pressure stabilization time min
T052 High pressure leak test time min
DP051 Maximum pressure leak mbar
R061 Vacuum rate mbar/min
V061 Vacuum pressure setpoint mbar abs
R071 First stage : Dilution rate mbar/min
DP071 First stage : Steam pressure rise mbar
T071 First stage : Dwell time min
R072 First stage : Vacuum rate mbar/min
V071 First stage : Vacuum pressure setpoint mbar abs
TC071 First stage : Minimum temperature for the end of DEC °C
RH071 First stage : Maximum humidity setpoint %RH
R073 Second stage : Dilution rate mbar/min
DP074 Second stage : Nitrogen pressure rise mbar
T072 Second stage :Dwell time min
R074 Second stage : Vacuum rate mbar/min
 Ref: HH-EO_User
EO STERILIZER Manual_Rev4
Author: GP
Creation date
15/10/2020
Revision date
04/08/2022
USER MANUAL Page 52 on 62

Parameter name
Description Units
(tag)
V072 Second stage : Vacuum pressure setpoint mbar abs
RH072 Second stage : Minimum humidity set point %RH
R081 Steam injection rate mbar/min
DP081 Steam pressure rise mbar
RH081 Steam injection humidity set point %RH
T091 DEC time min
R091 Vacuum valve modulation mbar/min
R092 Steam injection rate mbar/min
DP091 Steam stabilization pressure mbar
DP092 DEC pressure too low mbar
RH091 DEC humidity setpoint %RH
T101 Humidity stabilization time min
R101 Steam injection rate mbar/min
DP101 Differential pressure for steam reinjection mbar
Temp101 Minimum temperature for gas injections °C
R111 Vacuum rate mbar/min
V111 Vacuum pressure setpoint mbar abs
R121 First stage : Steam injection rate mbar/min
R122 First stage : Nitrogen injection rate mbar/min
R123 First stage : EO injection rate mbar/min
DP121 First stage : Steam injection rise mbar
DP122 First stage : Nitrogen inject rise mbar
DP123 First stage : EO injection rise mbar
T121 First stage : Steam dwell time min
T122 First stage : Nitrogen dwell time min
T123 First stage : EO dwell time min
R131 Second stage : Steam injection rate mbar/min
R132 Second stage : Nitrogen injection rate mbar/min
R133 Second stage : EO injection rate mbar/min
DP131 Second stage : Steam injection rise mbar
DP132 Second stage : Nitrogen injection rise mbar
DP133 Second stage : EO injection rise mbar
T131 Second stage : Steam dwell time min
T132 Second stage : Nitrogen dwell time min
T133 Second stage : EO dwell time min
R141 Third stage : Steam injection rate mbar/min
R142 Third stage : Nitrogen injection rate mbar/min
R143 Third stage : EO injection rate mbar/min
DP141 Third stage : Steam injection rise mbar
DP142 Third stage : Nitrogen injection rise mbar
DP143 Third stage : EO injection rise mbar
T141 Third stage : Steam dwell time min
T142 Third stage : Nitrogen dwell time min
 Ref: HH-EO_User
EO STERILIZER Manual_Rev4
Author: GP
Creation date
15/10/2020
Revision date
04/08/2022
USER MANUAL Page 53 on 62

Parameter name
Description Units
(tag)
T143 Third stage : EO dwell time min
N141 Number of gas injections (to repeat phases 12, 13 and 14) ---
R144 Vacuum rate (if several gas injections needed) mbar/min
TempEO EO injection temperature °C
Exposure mode control
0 : Reinjection disabled
MC151 ---
1 : Reinjection on differential pressure loss
2 : Reinjection with selectable time
T151 Exposure time min
R151 Nitrogen injection rate mbar/min
GT151 Gas concentration mg/L
R152 EO injection rate mbar/min
DP151 Differential pressure loss for EO or N2 reinjection mbar
DP152 EO re-injection rise mbar
DP153 N2 re-injection rise mbar
DP154 Maximum pressure increase during exposure time mbar
T152 Re-injection time min
T153 Over exposure time min
R161 Vacuum rate mbar/min
V161 Vacuum pressure setpoint mbar abs
Rinsing part 1 mode control
0 : Nitrogen
MC171 ---
1 : Atmospheric air
2 : Steam
R171 Rinsing part 1 rate mbar/min
DP171 Rinsing part 1 rise mbar
Rinsing part 2 mode control
0 : Nitrogen
MC172 ---
1 : Atmospheric air
2 : Steam
R172 Rinsing part 2 rate mbar/min
DP172 Rinsing part 2 rise mbar
T171 Dwell peak time min
T172 Dwell vacuum time min
R173 Vacuum rate mbar/min
V171 Vacuum pressure setpoint mbar abs
N171 Number of gas rinsing steps ---
V172 Vacuum break pressure set point mbar abs
Rinsing part 1 mode control
0 : Nitrogen
MC181 ---
1 : Atmospheric air
2 : Steam
R181 Vacuum break rate mbar/min
DP181 Vacuum break setpoint mbar
 Ref: HH-EO_User
EO STERILIZER Manual_Rev4
Author: GP
Creation date
15/10/2020
Revision date
04/08/2022
USER MANUAL Page 54 on 62

Parameter name
Description Units
(tag)
Rinsing part 1 mode control
0 : Nitrogen
MC191 ---
1 : Atmospheric air
2 : Steam
R191 Rinsing part 1 rate mbar/min
DP191 Rinsing part 1 rise mbar
Rinsing part 2 mode control
0 : Nitrogen
MC192 ---
1 : Atmospheric air
2 : Steam
R192 Rinsing part 2 rate mbar/min
DP192 Rinsing part 2 rise mbar
T191 Dwell peak time min
T192 Dwell vacuum time min
R193 Vacuum rate min
V191 Vacuum pressure setpoint mbar abs
N191 Number of gas rinsing steps ---
V192 Vacuum break pressure set point mbar abs
Rinsing part 1 mode control
0 : Nitrogen
MC201 ---
1 : Atmospheric air
2 : Steam
R201 Rinsing part 1 rate mbar/min
DP201 Rinsing part 1 rise mbar
Rinsing part 2 mode control
0 : Nitrogen
MC202 ---
1 : Atmospheric air
2 : Steam
R202 Rinsing part 2 rate mbar/min
DP202 Rinsing part 2 rise mbar
T201 Dwell peak time min
T202 Dwell vacuum time min
R203 Vacuum rate mbar/min
V201 Vacuum pressure setpoint mbar abs
N201 Number of gas rinsing steps ---
V202 Vacuum break pressure set point mbar abs
R211 Air injection rate mbar/min
R212 Vacuum rate mbar abs
V211 Air injection setpoint mbar abs
V212 Vacuum pressure setpoint mbar abs
T211 Vacuum maximum time min
N211 Number of degassing steps ---
R221 Vacuum break rate mbar/min
V221 Vacuum break pressure setpoint mbar abs
 Ref: HH-EO_User
EO STERILIZER Manual_Rev4
Author: GP
Creation date
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Revision date
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Parameter name
Description Units
(tag)
T231 Extra rinsing time min
R231 Air rinsing rate mbar/min
R232 Vacuum rate mbar/min
V231 Vacuum pressure setpoint mbar abs
V232 Air rinsing setpoint mbar abs
N231 Number of extra rinsing ---
R241 Air inlet rate mbar/min
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Author: GP
Creation date
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Revision date
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14. ANNEX III – CHAMBER SETUP PARAMETERS

These are the machine parameters. They are only accessible to MDS personnel and are adjusted at commissioning.
Default
Parameter name Parameter description Unit Actions Alarm
value
Sterilization chamber
If the difference between the
readings of these two sensors
Maximum pressure difference is greater than this value for
PT_MaxDiff between probes PT111 and mbar 5 more than 2 seconds, the AL_273
PT112 "Chamber pressure
discordance" alarm is
activated.
Maximum time for pressure If the time is greater than this
SC_MaxSITime hours 1
increase during steam injection value after opening the
corresponding valves and the
chamber pressure PT111
AL_264
Maximum time for pressure didn't increase enough, the
SC_MaxGIStepTime hours 1 "Time out on chamber
increase during nitrogen injection
pressure increasing" alarm is
activated.
After this time or if the
If the recirculation is activated pressure in the chamber is
SC_M_StartTime and no flow is detected (FSL121) min 1 greater than 300 mbar, the AL_50
then an alarm is activated "Chamber recirculation low
flow" alarm is activated
Opening time for humidity After this opening time, close
HS_OpenTime hours 1 NA
stabilization the valve
Closing time for humidity Time needed to close the
HS_CloseTime sec 1 NA
stabilization steam injection valves
Sterilization chamber - doors and gaskets
If the inflation/deflation
command were given and the
pressure switches PSL10 are
Timeout for gasket
DG_GasketMaxTime min 2 not activated/deactivated AL_172
inflation/deflation check
after this time, the "Gasket
adjusting timeout" alarm is
activated
Time that gasket remains
DG_GaskAdjTime Gasket inflated stabilization time min 2 inflated before proceeding to NA
the gasket integrity test
Deflating time second leak test (if Deflating time second leak
DG_ReinflateGasket sec 5 NA
first test failed) test (if first test failed)
If the deflation command or the If time with the PLC outputs
DG_GasketLeakTest integrity test are activated (PLC sec 30 activated is greater than this AL_82
output activated) and the PSL10- time and the PSL10 are not
 Ref: HH-EO_User
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Default
Parameter name Parameter description Unit Actions Alarm
value
PSL13 are not activated then the activated, then the alarm
system waits for this time to "loading door gasket leak" is
activate an alarm activated
Sterilization chamber - steam injection
Time needed to completely
Time needed to completely close
SI_CloseTime sec 1 close the steam injection NA
the steam injection valves
valves
Time that the master steam
Time that the master steam valve
SI_OpenTime hour 1 valve remains opened during NA
remains opened during the cycle
the cycle
Triggers an alarm if time is
SI_ChamberSteamTi Maximum time for steam greater than this value and
min 2 AL_243
me injection the chamber pressure didn't
increase enough
Maximum temperature for steam If TT111<=SI_MinTempInj or
SI_MaxTemp °C 100
injection TT111>=SI_MaxTemp and
during a certain time, stored
Minimum temperature for steam
SI_MinTempInj °C 15 in the parameter
injection AL_243
SI_ChamberSteamTime,
activates the "Steam injection
SI_ChamberSteamTi Time for the steam temperature
min 2 temperature out of range"
me out of range alarm activation
alarm.
Vacuum break
Maximum time for pressure After this time or if the
SC_MaxN2VBTime increase during nitrogen vacuum min 90 pressure in the chamber is
break greater than 300 mbar, the AL_264
Maximum time for pressure "Chamber recirculation low
SC_MaxAirVBTime min 30 flow" alarm is activated
increase during air vacuum break

Water jacket
Starting time for recirculation
WJ_StartTime sec 10 Water jacket start heating NA
pumps
Water jacket lower tolerance for Temp001-
WJ_InfTolReady °C 4
temperature setpoint WJ_InfTolReady<TT112<Temp
001+WJ_SupTolReady for
water jacket temperature to
NA
Water jacket upper tolerance for be OK (sets a flag to 1). This
WJ_SupTolReady °C 7 flag is then used as an initial
temperature setpoint
condition for the start of the
sterilization cycle.
Maximum temperature tolerance If the water jacket
WJ_InfTol °C 3
for water jacket temperature temperature is not in the
range Temp001- AL_256
Minimum temperature tolerance
WJ_SupTol °C 7 WJ_InfTol<TT112<Temp001+
for water jacket temperature
WJ_SupTol, the alarm "Water
 Ref: HH-EO_User
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Default
Parameter name Parameter description Unit Actions Alarm
value
jacket temperature out of
range" is activated
Number of samples used taken Parameters used for water
during water jacket heating to jacket regulation. They
WJ_SampleNb °C 120
calculate the average calculate the speed of
temperature temperature increase in the
water jacket. If the
temperature increases too
fast, the electrical heater is NA
stopped. If the temperature
Time before the start of the increases too low, it is
WJ_SampleTime sec 1
average temperature calculation activated. The regulation is
done in a similar way for the
cooling loop valves (heat
exchanger).
If the water jacket is running
and the FSL201 signal is not
Time without the FSL201
WJ_CirculationTime sec 5 activated after this time, the AL_77
activated.
alarm "water jacket low flow"
is activated.
If the time that the valves
Maximum time that the valves have been opened is greater
WJ_TemporizedOpe 2 hours 46
should be opened to heat the hours than this value, the alarm AL_145
nTime min
water jacket "water jacket heating too
long" is activated
WJ_TempAlarmTime Jacket maximum temperature
min 30 Triggers an alarm AL_257
r rise time
EO Vaporizer and vaporizer heating skid
Vaporizer temperature too high If TT401>VH_OverTemp, an
VH_OverTemp °C 90 AL_250
setpoint alarm is activated
If TT401>VH_MaxTemp, the
Vaporizer temperature high
VH_MaxTemp °C 80 vaporizer stops temperature NA
setpoint
regulation
If TT401<VH_MinTemp, the
Vaporizer temperature low
VH_MinTemp °C 60 vaporizer starts temperature NA
setpoint
regulation
Vaporizer temperature for If TT401<VH_MinTempReady,
VH_MinTempReady °C 40
“vaporizer ready” the vaporizer “will not be
ready” and after a certain
time defined by the AL_149
VH_HeatingMaxTim parameter “Vaporizer heating
Vaporizer heating maximum time min 30
e maximum time” an alarm is
activated
Vaporizer heating skid low
VH_MinFlowTime Time for vaporizer flow test sec 10 AL_69
circulation
 Ref: HH-EO_User
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Author: GP
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Default
Parameter name Parameter description Unit Actions Alarm
value
GI_MinEOChamberT Minimum chamber temperature If
°C 160
emp for EO injection TT181<=GI_MinEOChamberTe
mp or
GI_MaxChamberTe Maximum chamber temperature
°C 650 TT181>=GI_MaxChamberTem
mp for EO injection
p and during a certain time, AL_59
stored in the parameter
Waiting time for temperature out GI_ChamberEOTime, activates
GI_ChamberEOTime sec 10
of range alarm the "EO injection temperature
out of range" alarm.
GI_VapoPreHeatTim After this preheating time, EO
Vaporizer preheating time sec 0 NA
e injection can start.
If the pressure increase when
injecting EtO is smaller than
GI_MinDrumPressIn
EtO bottle low pressure setpoint mbar 4 this value, the "EO bottle AL_55, AL_56
crease
empty" alarm is activated,
depending on the bottle.
Delays the closing of the valve
EOEmptyVapoTime Time for vaporizer emptying (EO) min 1 so that EO doesn’t vaporize in NA
the pipes.
Delays the closing of the valve
so that nitrogen « flushes »
N2EmptyVapoTime Time for vaporizer emptying (N2) sec 5 NA
the pipes and removes any EO
remaining.
Vacuum pump
After this time with the pump
Starting time for the vacuum
VP_StartTime sec 10 activated and the valves NA
pump
PV181, 182 and 4403 opened.
Shut down of vacuum pump
Time of holding vacuum pump in
VP_DryOilTime min 1 after time expired if no new NA
operation after vacuum phase
vacuum request
Value to compare the logarithm If the logarithm of the
of the pressures to know if the pressure in the chamber
VP_TimeConst -- -0.4
pressure is increasing fast (PT111) and the current
enough AL_238
pressure is smaller than this
Time between calculations of value, the "vacuum speed to
VP_CalculateTime min 2 low" alarm is activated.
logarithm
Minimum vacuum pump If TT501>=VP_MinTemp the
VP_MinTemp temperature to start pulling from °C 50 vacuum pump starts pulling NA
the chamber from the chamber
If
TT501>=VP_MaxTemperature
VP_MaxTemperatur Temperature set point to activate
°C 150 _L then the "Vacuum pump AL_232
e_L temperature too high alarm
temperature too high" alarm
is activated
 Ref: HH-EO_User
EO STERILIZER Manual_Rev4
Author: GP
Creation date
15/10/2020
Revision date
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Default
Parameter name Parameter description Unit Actions Alarm
value
Time for vacuum pump oil After this preheating time the
VP_PreheatingTime preheating during the min 5 vacuum pump can start NA
sterilization cycle working
Number of vacuum pulls before
Every 5 vacuum pulls the
NA the emptying of the separator -- 5 NA
separator is emptied
with nitrogen
Maintenance operations
VP501 - Operating time for Generates a "maintenance
NA hours 32700 AL_134
vacuum pump maintenance necessary" alarm (level 1)
RC121 - Operating time for re- Generates a "maintenance
NA hours 32700 AL_135
circulation fan maintenance necessary" alarm (level 1)
EF161 - Operating time for back Generates a "maintenance
NA hours 32700 AL_136
venting maintenance necessary" alarm (level 1)
C201 - Operating time chamber
Generates a "maintenance
NA heating skid filling pump hours 32700 AL_139
necessary" alarm (level 1)
maintenance
EH201 - Operating time chamber
Generates a "maintenance
NA heating skid electrical heater hours 32700 AL_140
necessary" alarm (level 1)
maintenance
C401 – Vaporizer heating skid
Generates a "maintenance
NA circulation pump time for next hours 32700 AL_142
necessary" alarm (level 1)
maintenance
EH401 – Vaporizer heating skid
Generates a "maintenance
NA electrical heating time for next hours 32700 AL_144
necessary" alarm (level 1)
maintenance
CP701 - Scrubber skid circulation Generates a "maintenance
NA hours 32700 AL_145
pump time for next maintenance necessary" alarm (level 1)
Analogic sensor default alarms
AL_0 to AL_5,
If the analog input is greater AL_7, AL_8,
Maximum analog input value than this value, the alarm AL_9, AL_12,
Cal_MaxAnaValue -- 29030
before alarm activation "Sensor default" is activated, AL_13, AL_21,
depending on the sensor AL_22 and
AL_24

The parameter values can be printed in the form of a log.

 Ref: HH-EO_User
EO STERILIZER Manual_Rev4
Author: GP
Creation date
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Revision date
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15. ANNEX V – TROUBLESHOOTING

Alarm text message Triggering action What to check ?

Sterilizer & Skid

Sensor power supply on and sufficient.
Wires well connected and tightness at both ends (sensor +
Sensor power supply off
cabinet).
Sensor failure Wire disconnected / damaged
Sensor conditions (visual inspection).
Sensor fault / damaged
Exchange sensor with a similar one to diagnose if the fault is
from the sensor or the wires.
Electrical circuit breaker correctly adjusted.
Electrical failure Electrical circuit breaker triggered
Electrical issue on the protected component.
Emergency stop activated in electrical Emergency stop pushbutton not engaged.
Emergency stop
cabinet Emergency circuit reset.
Nitrogen supply of the gasket is correct.
Inflating/Deflating Valves are open.
Time out on gasket positioning
gasket Pressure switch working correctly.
Replace gasket if necessary.

Door opening/closing Maximum time to get the door in Manually verify the door motion.
too long position reached Adjust the compressed air flow if necessary.

Verify if any obstacle.

Door obstacle PCB sensor triggered Verify alignment of the sensor and its mirror.
Verify the sensor is working properly.
Temperature too hot Temperature really high.
Over temperature
Temperature transmitter deviation Temperature transmitter calibration check.
Valves line are open.
Low pressure PSL sensor triggered Pressure supply is sufficient.
There is no leak.
Circulation pump is working.
Low flow FSL sensor triggered Water pressure sufficient.
Flow switch correctly adjusted.
Pressure is too high.
Over pressure PSH sensor triggered Sensor correctly wired.
Sensor correctly adjusted.
Verify tightness of every chamber connections
Leak Maximum leak rate reached
Perform a manual leak test to try to find the leak.

Water jacket heating Temperature setpoint is not reach after Water jacket heating system working correctly (pump heating
too long the maximum time allowed element) Temperature is rising.

Valves of the EtO line are open.

If cylinder selected and the pressure
Lack of EtO Pressure of the EtO supply is sufficient.
increase is lower than the setup value
There is no leak.

Electrical cabinet power R201 power supply relay contact Power supply of the electrical cabinet is ON and sufficient.
failure detected Relay R201 is correctly supplied.

Scrubber
Verify the real water level.
Scrubber first stage low
LSL sensor triggered Refill if necessary with water and acid concentration.
level Sensor working correctly (can be checked with a magnet).
 Ref: HH-EO_User
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Author: GP
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Alarm text message Triggering action What to check ?

Verify the real water level.
Verify valves between the first stage and the additional tank
Scrubber first stage high
LSH sensor triggered are open.
level Sensor working correctly (can be checked with a magnet).
Empty if necessary.
Verify the real water level.
Scrubber level
Scrubber level discordance Sensors adjusted and working properly.
discordance Sensors correctly wired.

Preconditioning / Desorption
Maximum time to reach the temperature Heating system working correctly.
Heating too long Check temperature transmitter calibration, adjust and replace
setpoint exceeded
if necessary.
Humidification system working correctly.
Maximum time to reach the Valves are open and correctly adjusted.
Humidification too long
humidification setpoint exceeded Check humidity transmitter calibration, adjust and replace if
necessary.