ETHYLENE OXIDE GAS (EtO)

STERILIZERS

DE LAMA holds the Quality System certificates

ISO 9001 and EN 46001

ISO 9001 - Cert. n° 0351/2 ISO 9001 - Cert. n° IT - 4018

EN 46001 - Cert. n° 1275/0 EN 46001 - Cert. n° IT - 7773
 Ethylene oxide gas (EtO) sterilizers
DE LAMA DLOG and DLOG/V
Ethylene oxide sterilizers of DE LAMA DLOG and DE LAMA DLOG/V series have been specifically designed for sterilization
of products sensitive to high temperatures and to humidity (syringes, defluxers, catheters, cartridges for dialysis, plastic articles,
bandages, sutures, etc.). Such autoclaves can be used even for sterilization of powders which deteriorate by heating exposure.
For the wide range of product that can be treated, such sterilizers find application in parapharmaceutical and pharmaceutical
industry, in laboratories and hospitals.
Ethylene oxide autoclaves can be realized in two versions to satisfy different requirements:
DE LAMA DLOG series for working under pressure (3,5 abs. bar + vacuum) with mixtures of ethylene oxide and carbon dioxide
(usual composition 10% EtO + 90% CO2)
DE LAMA DLOG/ Vseries for working under vacuum (1,45 abs. bar + vacuum) with mixtures of ethylene oxide and carbon
dioxide (usual composition 90% EtO + 10% CO2) or with 100% ethylene oxide.
On request, DE LAMA can supply EtO sterilizers which are able to perform even saturated steam cycles.

Sterilizer DE LAMA DLOG/V-Ex 561 type,

capacity 14500 lts., with automatic sliding door

MAIN CONSTRUCTION FEATURES

Sterilizers are designed, manufactured and tested according to - front panels and eventual side walls in satin finish AISI 304
current Directives for construction of pressure vessels (PED), stainless steel
in full compliance with cGMP Guidelines, European Standards - piping and valves directly connected with the chamber in
and EN 1422, with procedures fixed by ISO 9001 and stainless steel
Quality Systems and are suitable to be validated - loop for heating and circulation of water inside the jacket,
according to European Standard EN 550. complete of pump
DE LAMA DLOG (equipment under pressure) and - efficient insulation with minimum heat loss and high power
DE LAMA DLOG/V (equipment under vacuum) are distin- economies

- double wall body Sterilizers are available with single or double door, hinged or
- sterilization chamber in AISI 316 or AISI 316L stainless steel automatic sliding type.
 PROCESS CONTROL
All DE LAMA control systems are provided with marking • up to 35 standard storable programmes
and are in compliance with European Directive EMC 89/336 • self-diagnostic
relevant to electromagnetic compatibility. • data holding in case of black-out
To satisfy Customers’ several production needs, DE LAMA • possibility of connection to an external PC for real-time
has realized different and flexible control system configurations. logger and data storage functions
All controllers give the possibility of data processing and to
issue detailed process documentation. On Customer’s request, DE LAMA can supply:
DE LAMA MASTER 6 - customized systems able to interface with supervisors
Distributed architecture modular control, processing and (SCADA) and external control facilities
recording system with industrial PC connected to a PLC - independent recording system for process data (according to
European Standard EN 1422)
• VGA colour LCD monitor (TFT 800x600)
• multifunction keyboard membrane type
• track-ball
• colour graphic printer with printout size A4
STERILIZATION PROGRAMMES
• interface Ethernet IEEE 802.3 and Profibus
• self-diagnostic and self-test High flexibility of control systems mounted on autoclaves
• graphic programming DE LAMA DLOG and DE LAMA DLOG/V allows to perform
• configurable dynamic synoptic panel cycles, automatic control cycles (vacuum leak test
• human / machine interface (HMI) with graphic management pressure leak test) and cycles free programmable by
• Windows-NT® / 2000 Professional® operating system It is possible to choose operating parameters (time,
• integrated management of all process parameters and humidity, gas concentration, etc.) according to type
sequences load, packaging and product placing inside the chamber.
Standard operating values are the following:
Sterilization time: usual gas exposure time is 3÷4 hours.
Sterilization time depends on both type of packaging and
other process parameters.
Product temperature: 40÷60°C
Set temperature value is non-stop holded by forced circu-
lation of water inside the jacket and, optionally, inside the

This system is very reliable with no risk of overheating and

temperature differences by steam use.
Product humidity: 40÷70 RH%
Such value is obtained with sterilizer under vacuum
condition to allow best conditioning of sterilization load.
Gas concentration inside the sterilizer: variable on the basis
of used gas mixture and operating pressure.
PC/PLC integrated logic computerized control system
Master 6 type
Graphic of changes in mixture consumption
(10% EtO + 90% CO2) to different concentrations
• unlimited possibility of programmes configuration and
memorization Q C= 800 mg/l 4.8 bar (480 kPa)
(kg)
• data holding in case of black-out
• software in compliance with GAMP3 Guidelines 140 C= 700 mg/l 4.2 bar (420 kPa)
Multilevel password and full compliance with FDA Regulations
C= 600 mg/l 3.6 bar (360 kPa)
Guidelines relevant to electronic signature (CFR 21-Part 11). 120
C= 500 mg/l 3 bar (300 kPa)
100
DE LAMA OLIMPYA/EXP3
Control, regulation, management and recording system C= 400 mg/l 2.4 bar (240 kPa)
80
equipped with high speed microprocessor: C= 300 mg/l 1.8 bar (180 kPa)
• monitor LCD 60
C= 250 mg/l 1.5 bar (150 kPa)
• multifunction keyboard membrane type C= 200 mg/l 1.2 bar (120 kPa)
40
• synoptic panel C= 150 mg/l 1 bar (100 kPa)
• colour graphic printer with printout size A4 20
• serial interface
• wide programming and management of all process para- 0
10 20 V (m3)
meters
 CYCLE BASIC PHASES
• Load of product to be sterilized
• Product heating by heated water circulating inside the jacket
and by internal fans preventing stratification which make
heat exchange easier.
• Pre-vacuum with value that can be automatically set up to 40
mbar (4 kPa) max.
• Vacuum leak test of the chamber before gas inlet
• Product conditioning by humidification up to a preset value
• Inlet of preheated and vaporized gas up to selected pressure
value
• Sterilization with gas pressure constant holding for a preset
time (up to 24 hours)
• Flushing by gas evacuation through vacuum pump and sterile
air inlet (pulsations) for a prefixed number of times.

CONDITIONING STERILIZATION FLUSHING

240’ 360’ 60’

3 bar
(300kPa)

60°C (333 K)
Sterilizer DE LAMA DLOG 931 type, 2 bar 50°C (328 K)
(200kPa)
40°C (313 K)
capacity 37734 lts., with hinged motorized door
1 bar ATMOSPHERIC
(100kPa) PRESSURE

0,2 bar
(20kPa)

GAS INLET
HUMIDIFICATION
VACUUM LEAK TEST
AIR REMOVAL
PRESSURE
Typical sterilization cycle
Functional diagram

Gas heater
Air inlet
Magnetic
coupling fan
CPU
Temperature probes
Pressure transducer
EtO gas mixture Humidity probe
bottle
TE01
TE02
TE03
TP
RH %

CPU Jacket
Heater of water
recirculating inside the jacket Chamber

Separating
Steam generator tank

Drain to be
conveyed to
neutralization
system
 AUXILIARY EQUIPMENT

Gas feeding, vaporizing and preconditioning equipment

Microprocessor system for control of relative humidity
Exhausted gas neutralization equipment
Device for continuous monitoring of EtO pollution arising from
eventual escapes of gas indoor

OPTIONALS
Doors heating through hot water flushing
Doors motorization system with electronic control
Automatic translation system for doors opening/closing
Internal ventilation system, with magnetic coupling fan groups,
to optimize homogeneity conditions throughout the
chamber (according to European Standard EN 1422)
Gas injection pipes washing system by nitrogen flux
Exhaust hoods for suction of eventual residual gas on doors
opening Sterilizer DE LAMA DLOG 541 type,
Electronic gas weighing system capacity 10875 lts., with hinged door
ADPE explosion-proof execution for sterilizers under vacuum
( DE LAMA DLOG/V)

TECHNICAL DOCUMENTATION
QUALITY CONTROL
AND ADDITIONAL ACTIVITIES
AND VALIDATION
To complete the supply, plants are always provided with
Equipment and relevant supervision systems are designed and following basic documentation:
manufactured to be easily validable in compliance with European - installation and operation manuals
Standard EN 550 and with quality standards for pharmaceutical
- P&I and technological diagrams
processes required by FDA.
- dimensional drawings and lay-out
Careful tests, specific controls and high technical professionality
in pre-validation activities assure that plants are fully in com- - bill of materials and components
pliance with highest required standards. - materials and calibration certificates
On request, DE LAMA supplies:
FAT and SAT protocols/documentation for pre-validation
Validation documentation customizable by the end-users
Full documentation for EN or FDA activity of validation
Theoretical/practical trainings reserved to Customers’
production and maintenance staff.

ASSOCIATED EQUIPMENT
AND ACCESSORIES
TO COMPLETE THE PLANT
Stainless steel trolleys for internal loading and external
moving, trays and boxes
Idle/motorized rollers internal conveyor for europallets
Full customized systems for loads handling

Sterilizer DE LAMA DLOG 631 type,

capacity 23392 lts., with automatic product loading system
 TECHNICAL DATA
ETHYLENE OXIDE (EtO) GAS STERILIZERS DE LAMA DLOG and DLOG/V type

MODEL CAPACITY CHAMBER INTERNAL DIMENSIONS MAXIMUM LOADING CAPACITY

WORKING PRESSURE IN EUROPALLETS
lts. HEIGHT WIDTH DEPTH abs. bar kPa (dimensions mm.800x1200)
mm mm mm

DLOG 101 640 800 800 1000 3,5 350 ---

DLOG 201 800 1000 800 1000 3,5 350 ---
DLOG 211 1000 1000 800 1250 3,5 350 ---
DLOG 311 1250 1000 1000 1250 3,5 350 1
DLOG 411 2925 1300 900 2500 3,5 350 2
DLOG 501 3625 1450 1000 2500 3,5 350 2
DLOG 511 5510 1450 1000 3800 3,5 350 3
DLOG 521 7250 1450 1000 5000 3,5 350 4
DLOG 531 8990 1450 1000 6200 3,5 350 5
DLOG 541 10875 1450 1000 7500 3,5 350 6
DLOG 551 12470 1450 1000 8600 3,5 350 7
DLOG 561 14500 1450 1000 10000 3,5 350 8
DLOG 611 16864 1600 1700 6200 3,5 350 10
DLOG 621 20400 1600 1700 7500 3,5 350 12
DLOG 711 21675 1700 1700 7500 3,5 350 12
DLOG 631 23392 1600 1700 8600 3,5 350 14
DLOG 651 27200 1600 1700 10000 3,5 350 16
DLOG 811 24225 1900 1700 7500 3,5 350 12
DLOG 911 25994 2150 1950 6200 3,5 350 10
DLOG 931 37734 2150 1950 9000 3,5 350 14

Models indicated in above table are only some of standard sizing for DE LAMA DLOG and DLOG/V.
Apart from the standard configurations indicated in the table, sterilizers can be proposed even with other dimensions, on request, according to
DLOG IN. 06 - 02
Customer's production needs.
Working parameters are for indication only and and can be modified in relation to Customer’s working requirements.

DE LAMA advises that technical data and

features indicated in this folder are subject to
without notice, owing to the continuous
development of the technology and the
research in the field.

S.p.A.

S T E R I L I Z E R S
Via Piemonte, 21 - 27028 San Martino Siccomario (PV) - Italy
Phone 0039 0382 559501 (5 lines) - 0039 0382 556627 ISDN - Fax 0039 0382 556224
http://www.delama.it - E-mail (Sales Dept.): [email protected]