BBST COMBO SERIES

SHIELDED ISOLATOR FOR SYNTHESIS AND DISPENSING

TD_BBST-COMBO-SERIES_R11_ENG – 21/02/19

ISO 9001 & ISO 13485 Certified Quality System

 TD_BBST-COMBO-SERIES_R11_ENG – 21/02/19

PLEASE NOTE
The total or partial reproduction of this document, using any means, without the permission of
Comecer S.p.A., is forbidden.

PLEASE NOTE
The photos and images provided are purely informative. Consequently, they cannot represent the
type of equipment specifically installed.

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 TD_BBST-COMBO-SERIES_R11_ENG – 21/02/19

INDEX

1 OVERVIEW.....................................................................................................................................................................................5
1.1 OVERVIEW........................................................................................................................................................................................................ 5
1.1.1 FEATURES AND BENEFITS................................................................................................................................................................... 6
1.2 REFERENCE STANDARDS........................................................................................................................................................................... 7
1.3 EQUIPMENT LINES........................................................................................................................................................................................ 8
1.4 MAIN EQUIPMENT........................................................................................................................................................................................ 8
1.4.1 EQUIPMENT AVAILABLE ON REQUEST.......................................................................................................................................... 9

2 CONSTRUCTIONAL FEATURES............................................................................................................................................... 10
2.1 DESCRIPTION OF MAIN COMPONENTS.............................................................................................................................................10
2.2 MACHINE STRUCTURE..............................................................................................................................................................................15
2.2.1 STRUCTURE............................................................................................................................................................................................15
2.2.2 COVERINGS.............................................................................................................................................................................................15
2.2.3 SHIELDING..............................................................................................................................................................................................15
2.2.4 SHIELDED GLASS WINDOW.............................................................................................................................................................15
2.2.5 AIR TIGHT SYSTEM...............................................................................................................................................................................15
2.2.6 DOORS......................................................................................................................................................................................................16
2.3 VENTILATION................................................................................................................................................................................................17
2.3.1 QUALITY OF THE AIR...........................................................................................................................................................................18
2.3.1.1 DISPENSING CHAMBER.....................................................................................................................................................................18
2.3.1.2 PRE-CHAMBER.......................................................................................................................................................................................18
2.3.1.3 DRAWING-SYSTEM..............................................................................................................................................................................18
2.3.1.4 WASTE COMPARTMENT.....................................................................................................................................................................18
2.3.1.5 SYNTHESIS CHAMBER........................................................................................................................................................................18
2.3.2 CONNECTION LAYOUT BETWEEN CHAMBERS.........................................................................................................................19
2.4 CONTROL PANEL.........................................................................................................................................................................................20
2.4.1 DATA TRANSFER...................................................................................................................................................................................20
2.4.1.1 DATA TRANSFER MODE LAY-OUT..................................................................................................................................................21

3 ACCESSORIES............................................................................................................................................................................ 22
3.1 MACHINE EQUIPMENT..............................................................................................................................................................................22
3.1.1 LED LAMPS FOR LIGHTING..............................................................................................................................................................22
3.1.2 LIGHT INDICATOR WITH BUZZER...................................................................................................................................................22
3.1.3 TECHNICAL GAS CONNECTIONS...................................................................................................................................................22
3.1.4 SHIELDED SEALED INLETS FOR RADIOFLUIDS........................................................................................................................23
3.1.5 SEALED CABLE ENTRY - MULTIDIAMETER ROXTEC SYSTEM..............................................................................................23
3.1.6 CF18 - SHIELDED CONTAINER FOR VIAL TRANSPORT...........................................................................................................23
3.1.7 TELE-PLIERS............................................................................................................................................................................................23
3.1.8 PRODUCT EXTRACTION SYSTEM - DRAWING SYSTEM.........................................................................................................24
3.1.9 VIAL OR VIAL/SYRINGE EXTRACTION SYSTEM (DRAWING SYSTEM) WITH INTEGRATED PASS THROUGH DOSE
CALIBRATOR.........................................................................................................................................................................................................25
3.1.10 WASTE COMPARTMENT.....................................................................................................................................................................26

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3.1.11 REMOTE PARTICLE COUNTER..........................................................................................................................................................26

3.1.12 DOSE CALIBRATOR MOD. IBC DOSE CALIBRATOR..................................................................................................................27
3.1.12.1 VIK-202 AND VIK-203 IONISATION CHAMBERS............................................................................................................27
3.1.12.2 IBC DOSE CALIBRATOR...........................................................................................................................................................28
3.1.12.3 LABEL PRINTER..........................................................................................................................................................................28
3.1.13 SMART GEIGER GM PROBE...............................................................................................................................................................29
3.1.14 PARTICLE COUNTER SET-UP............................................................................................................................................................29
3.1.15 AVCL: AUTOMATIC VENTILATION CLOSING SYSTEM.............................................................................................................29
3.1.16 CF18-T - CONTAINER TO TRANSPORT BOTTLES WITH TUNGSTEN SHIELDING...........................................................30
3.1.17 SXC - SHIELDED CONTAINER MADE OF LEAD FOR SYRINGES...........................................................................................30
3.1.18 SOFTWARE COMPLIANT WITH CFR21 PART11 (ELECTRONIC RECORDS; ELECTRONIC SIGNATURES)..............30
3.1.19 AUTOMATIC SYSTEM FOR FILTER INTEGRITY TEST (BUBBLE POINT TEST)...................................................................31
3.2 RELATED PRODUCTS.................................................................................................................................................................................32
3.2.1 GET: VIALS FRACTIONING SYSTEM...............................................................................................................................................32
3.2.2 TIMOTHEO-LT: VIALS FRACTIONING SYSTEM...........................................................................................................................32
3.2.3 ARGO: AUTOMATIC DISPENSING SYSTEM FOR VIALS...........................................................................................................32
3.2.4 FEBO RP: AUTOMATIC DISPENSING SYSTEM FOR SYRINGES.............................................................................................32

4 TECHNICAL DATA..................................................................................................................................................................... 33
4.1 VENTILATION AND FILTERS.....................................................................................................................................................................34
4.2 SHIELDINGS...................................................................................................................................................................................................34
4.3 OVERALL DIMENSIONS.............................................................................................................................................................................35

5 WORK AREA DISINFECTION KIT ........................................................................................................................................... 36

6 VALIDATIONS - FAT/SAT PROTOCOLS.................................................................................................................................. 37

6.1 MAIN STEPS OF VALIDATION:.................................................................................................................................................................37
6.2 FAT (FACTORY ACCEPTANCE TEST)......................................................................................................................................................37
6.3 SAT (SITE ACCEPTANCE TEST)................................................................................................................................................................38
6.4 OPTIONAL......................................................................................................................................................................................................38
6.4.1 IQ & OQ (INSTALLATION QUALIFICATION & OPERATIONAL QUALIFICATION)............................................................38

7 AFTER-SALES SERVICE............................................................................................................................................................ 39
7.1 MAINTENANCE SERVICES........................................................................................................................................................................39
7.1.1 PREVENTATIVE MAINTENANCE......................................................................................................................................................39
7.1.2 CORRECTIVE MAINTENANCE..........................................................................................................................................................39
7.2 REMOTE ASSISTANCE / HELP DESK......................................................................................................................................................39
7.3 TRAINING & CONSULTING.......................................................................................................................................................................39
7.4 UPGRADE & RETROFIT..............................................................................................................................................................................39
7.5 SPARE PARTS.................................................................................................................................................................................................39
7.6 VALIDATION & IQ / OQ..............................................................................................................................................................................40
7.7 SERVICE AS A CONTINUOUS SUPPORT TO CUSTOMERS............................................................................................................40
7.8 IMMEDIATE RESPONSE TO THE REQUESTS OF THE CUSTOMER..............................................................................................40
7.9 PLANNING......................................................................................................................................................................................................40

8 INSTALLATION REQUIREMENTS............................................................................................................................................ 41
8.1 NOTES REGARDING INSTALLATION.....................................................................................................................................................41

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 TD_BBST-COMBO-SERIES_R11_ENG – 21/02/19

1 OVERVIEW

1.1 OVERVIEW
The BBST COMBO shielded isolator has been designed specifically to combine a shielded housing for synthesis modules and
a fractioning area in sterile conditions (A LAF Class) in one system, in compliance with cGMP standards.
Its features guarantee radio-protection to the operator and the utmost effectiveness in decontamination and cleaning.
An airtight compartment, which is shielded on every side, is kept under negative pressure in order to produce the
radiopharmaceutical (automatic synthesis).
Then, the radiopharmaceutical can be transferred to the fractioning chamber (Class A) via an internal shielded duct. The
fractioning chamber with laminar flow has a dispenser that prepares the radiopharmaceutical doses in full compliance with
cGMP standards.

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1.1.1 Features and Benefits

• Work chamber for dispensing with air quality complying with Class A “At rest” (EEC-cGMP) and equipped with laminar
flow over the entire area
• Material introduction chamber (airlock) with air quality complying with Class B “At rest” (EEC-cGMP) and equipped with
handling gloves
• Synthesis chamber with air quality complying with Class B “At rest” (EEC-cGMP)
• Waste compartment with air quality complying with Class B “At rest” (EEC-cGMP) and removable tray
• Duct passing between dispensing chamber and waste area equipped with airtight door
• Duct passing between the synthesis camber and waste area, equipped with airtight connections to discharge liquid
waste
• Product extraction system in shielded container by means of specific drawer. The extraction occurs by means of a double
airlock system with air quality complying with Class B “At rest” (EEC-cGMP) and Class C “At rest” (EEC-cGMP)
• Dose calibrator compartment equipped with pneumatic system to move the vial in the well
• Possibility of installing a product extraction system equipped with “Pass-through dose calibrator”
• Possibility of setting up connection and integration with COMECER automatic dispensers
• Possibility to install the semi-automatic Bubble Point Test integrated with COMECER dispensers
• Technical cabinet to contain the control box for the synthesis module and any HPLC pump
• Epoxy-coated carbon steel support structure
• 316L AISI stainless steel work chambers with Mirror-Bright internal surface finish, TIG continuous welds, and widely
rounded corners
• Shielded side sliding door between material introduction chamber and dispensing chamber.
• Shielded and hinged front doors
• Chambers tightness ensured by inflatable gasket system, placed on the perimeter of the openings
• 304 AISI stainless steel front coverings, easy to decontaminate, separates the laboratory area (front) from the technical
cabinet (rear)
• Shielding elements realised from primary ingots with Pb 98% + Sb 2% purity.
• Shielded chambers under constant negative pressure
• Filtration system to generate laminar flow in the Class A chamber, made with H14 absolute filtering cartridge
• Filtration system for Class B Drawing System and Solid Waste (if present) with HEPA H14 absolute filtering cartridge
• Air outlet filtration system made with active carbon filtering cartridge
• 7” touch-screen operator panel to check and trace the critical parameters of the machine both in “at rest” or “in operation”
mode
• 1/8” technical gas supply lines with shut-off valves, which can be controlled from the outside
• 6 mm technical gas supply line with shut-off valves, which can be controlled from the outside
• Radiofluid airtight shielded inlets for the synthesis chamber and airtight shielded capillary passages between the
synthesis chamber and the dispensing chamber
• Cable input through multi-diameter airtight system for the synthesis chamber and the dispensing chamber
• Electric power supply sockets protected and controlled from the operator panel for the synthesis chamber and the
dispensing chamber
• Tele-pliers on special ball bearings for high sensitivity and precision-movement handling
• Possibility of installing a Geiger-Muller probe to detect radioactivity inside the synthesis and dispensing cell and door
interlock management
• The synthesis chamber can be connected to the contaminated air compression and storage system manufactured by
Comecer (AVC-ACS) or by a third party (AVC-DL, connection to be made by the customer)
• An automatic ventilation closing system (AVCL) can be installed for the main chamber and for any pre-chamber, with set-
up for connecting hydrogen peroxide generators (VPHP). The system allows you to automatically conduct the leak test.
• Set-up for a particle counter sensor in the main chamber and in the material introduction pre-chamber

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1.2 REFERENCE STANDARDS

This product is manufactured in compliance with the following EU Directives:
• Directive 2006/42/EC on machinery, and amending Directive 95/16/EC (Machinery Directive)
• Directive 2014/30/EU relating to electromagnetic compatibility (EMC)
And, to the extent applicable, with the harmonized standards:
• EN ISO 12100:2010 Safety of machinery - General principles for design - Risk assessment and risk reduction (ISO
12100:2010)
•• (following the ISO TR 14121-2:2012 - Safety of machinery - Risk assessment - Part 2: Practical guidance and examples
of methods)
• EN 60204-1:2006 Safety of machinery - Electrical equipment of machines - Part 1: General requirements (IEC 60204-
1:2005 (PEQ)
• EN 61000-6-2:2005 - Electromagnetic compatibility (EMC) Part 6-2: Generic standards - Immunity for industrial
environments (IEC 61000-6-2:2005)
• EN 61000-6-4:2007 - Electromagnetic compatibility (EMC) Part 6-4: Generic standards: Emission for industrial environments
(IEC 61000-6-4:2006)
And with the following standards and technical specifications:
• ISO 10648-1:1997 Containment enclosures - Part 1: Design principles
• ISO 10648-2:1994 Containment enclosures - Part 2: Classification according to leak tightness and associated checking
methods
• ISO 14644-1:2015 Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness by
particle concentration
• ISO 14644-3:2005 Cleanrooms and associated controlled environments - Part 3: Test methods
• ISO 14644-7:2004 Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods,
gloveboxes, isolators and mini-environments)
The product was designed in compliance with the following requirements:
• Eudralex - Volume 4 Good Manufacturing Practices (GMP) Guidelines.

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1.3 EQUIPMENT LINES

The machine is available in different equipment lines to fulfil the requirements of any production centre.

BBST COMBO

BBST COMBO WITH PASS THROUGH DOSE CALIBRATOR

1.4 MAIN EQUIPMENT

BBST COMBO WITH

DOSE CALIBRATOR
Models

PASS THROUGH
BBST COMBO
Main equipment

European electrical power supply R R

American electrical power supply R R
Tele-pliers S S
Led lighting S S
Notebook support S S
Indicator light for machine status S S
Internal connections for technical gases S S
Internal inlets for radiofluid capillaries S S
Sealed cable input S S
Dispensing chamber S S
Synthesis chamber S S
Side pharmaceutical pre-chamber for materials introduction S S
Solid waste compartment S S
Dose calibrator S S
Pass through dose calibrator - S
Smart Geiger (internal environmental monitoring system) O O
Automatic Bubble Point Test * O O
Product extraction system (Drawing system)
Product extraction system for vials and syringes S -
Product extraction system for vials and syringes with integrated pass through
- S
calibrator
Dispenser set-up
GET dispensing system set-up O O
TIMOTHEO LT dispensing system set-up O O
ARGO dispensing system set-up O O
FEBO RP dispensing set-up O -
Shielded container
Vial shielded container mod. CF18 S S
Vial shielded container mod. CF18-T O O
Syringe shielded container mod. SXC O O
*For Comecer dispensers (not included)
S= Standard; O= Option; R= Configurable when placing order

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1.4.1 Equipment available on request

BBST COMBO WITH

DOSE CALIBRATOR
PASS THROUGH
BBST COMBO
Available accessories

Steel coverings reaching the laboratory ceiling O O

CFR21 licence PART 11 O O
Dose calibrator model
IBC Dose Calibrator up to 20 Ci R R
DVK-103 pass through dose calibrator up to 2 Ci - S
AVC Light
(including set-up for VPHP with manual valve on the VPHP line and leak test
functionality)
Dispensing chamber R R
Main dispensing chamber & Pre-chamber R R
AVC
AVC with anti-implosion system set-up for ACS (including leak test) for the
R R
synthesis chamber
AVC with anti-implosion system set-up for Delay Line (including leak test) for the
R R
synthesis chamber
Particle counter
Dispensing chamber R R
Main dispensing chamber & Pre-chamber R R
S= Standard; O= Option; R= Configurable when placing order

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2 CONSTRUCTIONAL FEATURES

2.1 DESCRIPTION OF MAIN COMPONENTS

All installed parts are defined by the selected configuration

1
18 2
17 3

4
5

16 5

6
15
7
14
8
13 9

12 10

11
Ref. Description Ref. Description
1 Air inlet grille from laboratory 10 PC shelf
2 Light indicator with buzzer 11 Product extracting system - Drawing System
3 Touch screen operator panel 12 Waste compartment shielded door
4 Emergency stop button 13 Synthesis chamber front door
5 Technical gas valve control 14 Pre-chamber door for material introduction
6 Internal radioactivity monitoring display 15 Upper technical compartment
7 Dispensing chamber front door 16 Camera monitor
Pressure regulators + pressure gauges for
8 Shielded glass window 17
technical gas
9 Tele-pliers for manipulation 18 Connection test compartment

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Dispensing Chamber

3
11

10

9 5
8
7

Rif. Descrizione
1 Laminar air flow filter
2 Internal radioactivity monitoring probe
3 Air flow speed monitoring probe
4 Well access hole - Dose calibrator
5 Product extractor duct
6 Waste discharge duct
7 Material infeed pre-chamber internal door (Airlock)
8 Shielded sealed inlets for radiofluids
9 Cable entry through multidiameter sealed system
10 Technical gas connection
11 Electric sockets

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Pre-chamber

1
3

2
4

Ref. Description
1 Pre-chamber
2 Sliding tray
3 Materials transfer door
4 Inflatable gasket

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Synthesis chamber

LATERAL CONNECTIONS

8
7

1
6
5
2
4
3

Ref. Description
1 Electrical sockets
2 Multidiameter cables passage
3 Radio-fluids passage to cyclotron
4 Radio-fluids passage to dispensing
5 Technical gases inlet with manometers for pressure adjustment
6 Synthesis modules connection - Optional
7 Waste air passage to waste compartment
8 Radio-fluids passages to waste compartment

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Upper technical compartment

2
1

Ref. Description
1 Ethernet port to frontal panel
2 Synthesis modules connection - Optional
3 Multidiameter cables passage
4 Electrical sockets

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2.2 MACHINE STRUCTURE

All installed parts are defined by the selected configuration

2.2.1 Structure

Supporting frame
Support frame made of tubular AISI steel with outer Scotch-BriteTM surface finishing. The joints are welded with TIG welding
in an argon gas atmosphere; the weld seams are ground and smoothened.

Work area
The work chamber is made from a single block of AISI 316L stainless steel, with Mirror-Bright internal surface finish, TIG
continuous welds, then ground and smoothed and widely rounded corners. These characteristics ensure maximum ease
and effectiveness of the decontamination procedures and prevent the infiltration and accumulation of contaminants in the
joints.

2.2.2 Coverings
All external coverings are realised completely in AISI 304 stainless steel with Scotch-Brite TM finishing.
The front coverings of the equipment can be prepared and installed in order to maintain an adequate seal level to reach the
correct classification of the laboratory in which the machine will be installed.
The coverings can therefore separate a differential pressure area (positive or negative) and act as a physical barrier of
separation between the laboratory area (front) and the technical area (rear). If this functionality is required, the layout of the
laboratory must be evaluated in its entirety along with the size of the classified areas, in order to optimise the design of the
machine and then confirm the flow rates required by the ventilation system (HVAC) on site.

2.2.3 Shielding
The lead shields, with adequate overlapping, are fixed to the cell support structure using steel supports. The shielding
elements are realised from primary ingots with Pb 98% + Sb 2% purity.

2.2.4 Shielded glass window

High lead content glass (density ≥ 4.8 g/cm3) and is perfectly transparent. The glass is mounted in a shielded frame to
guarantee the continuity of the shielding at the points where it joins the surface of the door.

2.2.5 Air tight system

An inflatable gasket system, along the perimeter of the openings, guarantees

chamber closure and quick, safe and easy movement of the panels, with no
mechanical locking systems. The control system guarantees air sealing and
maintains the position of the panels even if there is no electric and pneumatic
power supply, while allowing the emergency opening through the use of a
manual valve.

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2.2.6 Doors

Material introduction pre-chamber

The equipment is supplied with one or more doors to guarantee maximum air-
tightness and, at the same time, maximum comfort for the operator.
The door, hinged sideways, is made of Plexiglass or Lexan (optional in cases of
use of VPHP) and comes with gloves flanges.
The door is equipped with interlocks with the equipment’s safety systems.
It is used to introduce materials and for cleaning the chamber.

Work chamber

Shielded hinged door on bronze self’-lubricating bushings and bearings.

The door is equipped with electric lock with mechanical lock and sensor that
signals the close position, opening is controlled via the operator panel. The
same system may also be equipped with a functional interlocking opening,
dependant on the internal monitoring of radioactivity in the equipment and/or
on the laboratory’s safety systems.

Communication door

Sliding shielded lateral door. This door can be opened by controlling the
deflation of the inflatable gasket from the panel, and using the gloves available
on the pre-chamber. The door can be fitted with interlocks that may be
provided with an environmental detection system to prevent it from opening
in the presence of radiation.

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2.3 VENTILATION

3
1

2 4

The internal upper wall of the main work chamber has an absolute filter that covers the entire work area (Ref. 1). The entire
internal volume of the chamber is continuously washed by a flow of air with parallel currents and with a minimum speed
gradient (Ref. 2).
The mass of air drawn from the laboratory and filtered through the absolute filter is moved by a fan (Ref. 3) which recirculates
the air through the absolute filter (Ref. 1). The flow is directed vertically downwards and the air passes through a perforated
surface (Ref. 5) and returns to the fan through a return air manifold (Ref. 4). The perforated surface can be removed to ensure
cleanliness and decontaminability.
The speed of the flow corresponds with the features requested for the critical areas (Class A) by the EEC-GMP Directive (1997
Issue): 0.45 m/sec ± 20%.
A small fraction of the mass of air (± 20%) is extracted from the chamber through the exhaust pipe, in order to guarantee
constant internal negative pressure and filtered through an active carbon filter. This condition, along with perfect sealing,
guarantees safety in the case of accidents with the release of radioactive product. The complete washing of the laminar flow
currents on the entire work surface compensates the impossibility, owing to radioprotection necessity, to operate in a work
environment with positive pressure in compliance with the Standards suggested by EEC-GMP (10/15 Pa).

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2.3.1 Quality of the air

2.3.1.1 Dispensing Chamber

The particle content in the air complies with the ISO 14644-1 and EEC-cGMP requisites.
For grade A “At rest” (EEC-cGMP):
• Class ISO 5 (ISO 14644-1): ≤ 3520 part./m3 for particles Ø ≥ 0.5 µm
• Class ISO 4.8 (ISO 14644-1): ≤ 20 part./m3 for particles Ø ≥ 5.0 µm
The speed of the flow corresponds with the features required for critical areas (Grade A) in accordance with the EEC-cGMP
Directive: 0.45 m/sec ± 20%.

2.3.1.2 Pre-chamber
The particle content in the air complies with the ISO 14644-1 and EEC-cGMP requisites.
For grade B “At rest” (EEC-cGMP):
• Class ISO 5 (ISO 14644-1): ≤ 3520 part./m3 for particles Ø ≥ 0.5 µm
• Class ISO 5 (ISO 14644-1): ≤ 29 part./m3 for particles Ø ≥ 5.0 µm

2.3.1.3 Drawing-System
The particle content in the air complies with the ISO 14644-1 and EEC-cGMP requisites.
For grade B “At rest” (EEC-cGMP):
• Class ISO 5 (ISO 14644-1): ≤ 3520 part./m3 for particles Ø ≥ 0.5 µm
• Class ISO 5 (ISO 14644-1): ≤ 29 part./m3 for particles Ø ≥ 5.0 µm

2.3.1.4 Waste compartment

The particle content in the air complies with the ISO 14644-1 and EEC-cGMP requisites.
For grade B “At rest” (EEC-cGMP):
• Class ISO 5 (ISO 14644-1): ≤ 3520 part./m3 for particles Ø ≥ 0.5 µm
• Class ISO 5 (ISO 14644-1): ≤ 29 part./m3 for particles Ø ≥ 5.0 µm

2.3.1.5 Synthesis chamber

The equipment has a ventilation system which guarantees protection for both the product and the operator.
The chamber is kept constantly in negative pressure conditions to prevent the release of radioactivity to the outside in the
event of an accident.
The particle content in the air complies with the ISO 14644-1 and EEC-cGMP requisites.
For grade B “At rest” (EEC-cGMP):
• Class ISO 5 (ISO 14644-1): ≤ 3520 part./m3 for particles Ø ≥ 0.5 µm
• Class ISO 5 (ISO 14644-1): ≤ 29 part./m3 for particles Ø ≥ 5.0 µm

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2.3.2 Connection layout between chambers

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2.4 CONTROL PANEL

The equipment has one or more 7” touch screen operator control panels
suitable for use with gloves.
The operator control pane allows for the traceability of critical system
parameters both at rest and in operation.
The control panel further allows for equipment management avoiding the
use of buttons and switches, allowing for a surface which can be entirely
decontaminated and sterilised.
Particular elements of the system include the use of large icons and pages
dedicated to single critical parameters, notwithstanding the possibility of
continually viewing a panorama of parameters to be controlled on the front
page.
The control panel can simultaneously monitor more than 100 parameters with
relevant warnings and alarms for complete control of the equipment and its
components.
Up to 8 password levels with different privileges can be entered and up to 21
operators with dedicated Usernames and Passwords can be set, in order to
trace the operations performed.
The operator panel allows you to save all the logs in an internal memory buffer.

2.4.1 Data transfer

Critical data can be exported according to the following modes:

1- standard: USB port at the front of the equipment - side (see fig).
2- on request: Ethernet connection from PLC for transferring instantaneous
values; the reception and storage of these values must be carried out from the
customer’s system (PC, SCADA, etc.)
As for the second mode, Comecer can provide:
• PLC Ethernet connection (switch ETH)
• Software export data
• Documents with data interconnection specifications.
Comecer does not supply:
• Ethernet cable
• Data acquisition external system

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2.4.1.1 Data transfer mode lay-out

ETHERNET cable
USB cable
B

PLC
C
HMI
D

E
A

F
1 2
Ref. Description
A USB key (not supplied)
B USP port
C HMI internal memory
D Ethernet Port on PLC
E Switch ETH
F External Computer (responsibility of the customer)

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3 ACCESSORIES

3.1 MACHINE EQUIPMENT

3.1.1 LED lamps for lighting

The equipment has one or more low-consumption LED lamps for illuminating
the entire work area.

3.1.2 Light indicator with buzzer

The equipment has one or more lights and buzzers to signal the operating
status with the following logic:
· Flashing red light + buzzer: unsafe (or potentially unsafe) status. Danger for the
operator / Emergency
· Fixed yellow light: abnormal condition / presence of one or more alarms. An
operator is required to restore the machine normal operation. It is not related
to a danger for the operator.
· Flashing green light: machine in preparation. The machine is waiting to reach
the normal status and/or normal condition it is intended for.
· Fixed green light: normal status (safe). Expected operating condition.

3.1.3 Technical gas connections

Inside the working chamber there are connections for technical gas lines useful
for the correct operation of synthesis modules installed on the equipment.
The connections to technical gas lines are in AISI 316 stainless steel with
spherical intercept valves with flow control control handwheels and gas
identification plates.

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3.1.4 Shielded sealed inlets for radiofluids

Every chamber is equipped with a steel plate with radiopharmaceutical capillary

inlets, which come from the floor within a lead shielded duct. The inlet to the
chamber is manufactured with airtight fittings.

3.1.5 Sealed cable entry - Multidiameter Roxtec system

The Multidiameter Roxtec system is a special system that allows introducing

and subsequently sealing a large number of cables of various sizes. It is a
versatile type of cable gland with an efficient use of the useful space that allows
saving time during installation. Quick and reliable sealing guarantees perfect
tightness. The system is based on multi-diameter modules that can be adjusted
to adapt to a wide range of cables. The multiple layer technology allows the
module to adapt to cables with different diameters by simply leafing through
the various layers starting from the centre.

The Multidiameter Roxtec system offers the advantage of avoiding the removal of the connectors from the cables when
introducing them and ensuring perfect sealing.
The following cables can be ducted:
• 12 cables with diameter between 3.5 and 10.5 mm
• 2 cables with diameter between 3.5 and 14.0 mm
The system is mounted on a stainless steel support fixed to the wall of the chamber with sealing gaskets.

3.1.6 CF18 - Shielded container for vial transport

The CF18 shielded container is made of 40 mm lead and fully coated with AISI
304 stainless steel. It is used for the transportation of radioisotopes. The cover
is locked with a stainless steel locking ring, also in stainless steel; air sealing is
guaranteed by a silicon gasket on the upper part of the container itself; the CF18
cover is equipped with a stainless steel retractable handle, for easy transport.
Thanks to design of the CF18 many containers can be easily stacked, optimizing
your storage operations.

3.1.7 Tele-pliers

2 tele-pliers on special ball bearings for high-sensitivity handling and movement

precision.
Its are used to operate inside the main chamber. The tele-pliers can be regulated
using the relevant knob. To grip an object, grip it and tighten the lever.

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3.1.8 Product extraction system - Drawing System

The Drawing System is a manual system that allows the transfer of vials or
shielded syringes containing radiopharmaceutical from inside the cell to the
external environment while keeping the work chamber environment class
unaltered.
The passage of the vial/shielded syringe from inside the cell to the shielded
container for transport (mod. CF18 or CF18T for vials - SXC for syringes) takes
place thanks to a pneumatic discharge system that is activated by the operator,
thus allowing the vial/syringe to move down into the container.
The supported formats are:
• DIN/ISO 20 vials (external outlet diameter 20 mm) with 10ml capacity
(standard Comecer format D25.5 x H53.5) up to 30ml capacity (maximum
dimensions D36 x H65)
• Standard 10ml BD type syringes with Comecer pierceable cap (equipped with PST shielding)
• Standard 5ml BD type syringes with Comecer pierceable cap (equipped with PST shielding)
65 MAX

O 36 MAX

Depending on the format of the vial or syringe, a special shielded container is provided for transport (check the type and
supply).
If vials are discharged (in the supported formats), the system is able to automatically remove the cover of the shielded
transport container (type CF 18) before starting the discharge cycle, and automatically positions it again on completion.
Before extracting it, the operator must only lock the safety lever.
If syringes are discharged (in the supported formats), the cover of the shielded container (series SXC) is removed by the
operator before starting the discharge cycle (and also positioning it again later).

End product format Supported Transport container

DIN/ISO 20 vials (external outlet diameter 20 mm) with 10ml
Yes CF18 / CF18-T
capacity (standard Comecer format D25.5 x H53.5)
Standard 10ml BD type syringes with Comecer pierceable cap and
Yes S10CP
PST shielding
Standard 5ml BD type syringes with Comecer pierceable cap and
Yes S5CP
PST shielding

CAUTION
The shielded containers standard Comecer (CF18 or CF18-T) may not be able to accommodate bottles
with a diameter greater than 30 mm. Should be carefully assessed the datasheet of the container you
intend to use for the discharge of the bottle.

NOTE
In case of vial sizes different from the standard one, please contact Comecer.

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3.1.9 Vial or vial/syringe extraction system (Drawing System) with integrated pass through dose calibrator
The drawing system equipped with pass through dose calibrator is an automatic
measurement and extraction system for vials and syringes.
The system can be integrated in dispensing hot cells for production of
radiopharmaceuticals.
The system is based on a special patented ionising chamber that allows the
passage of the vial or syringe without the limits imposed by the “well” solution.
The “pass through” ionising chamber allows a unidirectional flow along the
axis of the object being measured. The chamber has been designed to obtain
the same measurement precision of a normal ionising chamber; this way, a
measurement process equal to a solution with traditional calibrator is obtained.
The integrated system allows you to perform one measurement step and then
a delivery step of the vial or syringe in one single automatic cycle.
The supported formats are:
• DIN/ISO 20 vials (external outlet diameter 20 mm) with 10ml capacity (standard Comecer format D25.5 x H53.5) up to
30ml capacity (maximum dimensions D36 x H65)
• Standard 5ml BD type syringes with Comecer pierceable cap (equipped with PST shielding)
• “Letho” Comecer cartridges with 9ml capacity and Comecer pierceable cap, equipped with PST shielding
65 MAX

O 36 MAX

Depending on the format of the vial or syringe, a special shielded container is provided for transport (check the type and
supply).
If vials are discharged (in the supported formats), the system is able to automatically remove the cover of the shielded
transport container (type CF 18) before starting the discharge cycle, and automatically positions it again on completion.
Before extracting it, the operator must only lock the safety lever.
If syringes are discharged (in the supported formats), the cover of the shielded container (series SXC) is removed by the
operator before starting the discharge cycle (and also positioning it again later).
End product format Supported Transport container
DIN/ISO 20 vials (external outlet diameter 20 mm) with 10ml
Yes CF18 / CF18-T
capacity (standard Comecer format D25.5 x H53.5)
Standard 5ml BD type syringes with Comecer pierceable cap and
Yes S5CP
PST shielding
Comecer “Letho” cartridge with PST shielding Yes LETHO holder

CAUTION
The shielded containers standard Comecer (CF18 or CF18-T) may not be able to accommodate bottles
with a diameter greater than 30 mm. Should be carefully assessed the datasheet of the container you
intend to use for the discharge of the bottle.

NOTE
In case of vial sizes different from the standard one, please contact Comecer.

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3.1.10 Waste compartment

Waste is disposed of by means of a hole on the work surface equipped with shielded connection. The drain hole has a closed
shielding.
The collected solid waste is conveyed inside a stainless steel casing containing a plastic bucket (standard container for
hospital waste).

WASTE LATERAL VIEW (LIQUID) WASTE FRONT VIEW (SOLID)

RADIOFLUID PASSAGE
TO SYNTHESIS

LIQUID WASTE 4 LITERS

WASTE TANK

REMOVABLE TRAY

For the Liquid waste, inside the compartment the following bottles receive the different fluids that come from the synthesis
module:
• nr. 2 bottles of 250 ml
• nr. 2 bottles of 100 ml
• nr. 2 bottles of 30 ml

3.1.11 Remote particle counter

The remote particle counter was designed for continuous monitoring.
It simultaneously controls particle sizes 0.5μm and 5.0μm with a flow speed of 1.0 CFM (28.3 LPM).
The sensor is directly built into the control panel of the cell using Modbus/RS485 communication.
The counter complies with ISO 21501-4. The counter complies with GMP requirements and is suitable to monitor classified
environments.

Features and Benefits

• 2 channels (0.5μm e 5.0μm)
• 1.0 CFM (28.3 LPM)
• 2-year warranty
• Accuracy ± 3%
• Modbus/RS485 output
• Compliant with ISO 21501-4 and JIS B9921
• Stainless steel structure

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3.1.12 Dose calibrator mod. IBC Dose Calibrator

Comecer is one of the leading manufacturers of dose calibrators for nuclear medicine and radiopharmacology departments.
The dose calibrators are also known as radioisotope calibrators, radionuclide calibrators, Curie measurement systems and
activity meters.
Based on 25 years of experience, combined with the technological knowledge of Veenstra Instruments, today Comecer
offers a vast range of models to satisfy any type of request.
Comecer is specialised in checking, measuring and safely managing radiation. In addition to this specific know-how, Comecer
also takes care of design software, mechanics and electronics, obtaining and wide range of unique products for nuclear
medicine, radiochemistry, radiopharmacy and calibration laboratories.

3.1.12.1 VIK-202 and VIK-203 ionisation chambers

The heart of every Comecer dose calibrator is the ionisation chamber: a completely digital detector that gives a fast, reliable
reading. The 100% digital output allows the detector to be flexibly integrating into other instruments or structures with no
need for a converter or a separate reading unit.
The VIK-202 ionisation chamber is pressurised at 14 bar (absolute) of Argon and its measurement range is up to 2 Ci (74 GBq)
of F-18; the VIK-203 ionisation chamber is also available, pressurised at 1.4 bar (absolute) of Argon, for a measurement range
of up to 20 Ci (740 GBq) of F-18.

Camera di ionizzazione VIK-202 Camera di ionizzazione VIK-203

Camera di ionizzazione Pressurizzata (14 bar ass. Argon) Pressurizzata (1,4 bar ass. Argon)
Tensione di ionizzazione 150 V batteria al litio
Dimensione pozzetto Ø 69 mm x 280 mm
Liner a pozzetto (parte interna) Ø 57 mm x 270 mm
>200 GBq (Tc-99m), >70 GBq (F-18) >2000 GBq (Tc-99m), >700 GBq (F-18)
Saturazione
>6 Ci (Tc-99m), >2 Ci (F-18) >60 Ci (Tc-99m), >20 Ci (F-18)
Intervallo energia 25 keV - 3 MeV
Schermatura in piombo 3 mm Pb
Linearità ± 1% tra 1 MBq e 200 GBq (Tc-99m) ± 1% tra 50 MBq e 700 GBq (Tc-99m)
Accuratezza elettrometro ± 1%
Accuratezza test HV ± 5%
Coefficiente di temperatura 0,1%/°C tra 10°C e 40°C a 5 MBq e superiore
Riproducibilità ± 1% su 24 ore, condizioni stabili
± 3 %, a seconda della sorgente di calibrazione specifica e delle variazioni
Accuratezza totale
geometriche
Tempi di risposta Massimo 2 secondi per il 95% del valore finale
Isotope factor Regolazione digitale
Guadagno Regolazione digitale
Correzione degli errori Regolazione digitale
Regolazione dello zero Regolazione digitale
Calibrazione Regolazione digitale
Sottrazione del fondo Controllo digitale
Test alta tensione Controllo digitale
Interfaccia Interfaccia camera di ionizzazione
Alimentazione 5 VDC, 250 mA
Cavo 2,5 metri
Dimensioni Ø 150 mm (inferiore Ø 160 mm) x 451 mm altezza
Peso 15,5 kg

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3.1.12.2 IBC Dose Calibrator

The IBC Dose Calibrator is a completely digital dose calibrator managed by IBC-
LITE. The ionisation chamber is connected directly to a PC with Windows (not
supplied).
Like all Comecer dose calibrators, each model is used in combination with a
completely digital VIK-202 or VIK-203 model ionisation chamber.
The IBC-LITE software offers a simple and user-friendly interface that supports all
functions required for dose calibration when preparing radiopharmaceuticals.
The IBC Dose Calibrator is suitable for radio pharmacy use within a Nuclear
Medicine department, as it can be easily integrated into any type of
Microbiological Safety Cabinet.

Reading Curie / Becquerel (selectable)

MBq 0.001
Resolution
μCi 0.01
Operating system Windows 7 or Windows 10
1x RS-232 interface for each ionisation chamber
Peripheral interface
1x USB interface for the optional label printer.
Defined Isotopes > 55 selectable isotopes
User-definable isotopes Limitless
Pre-set isotopes 15
Voltage V 100 – 240
Frequency Hz 50-60
Power W 15

Features IBC-LITE software

• Developed according to the GAMP-5 methodology
• Built-in isotope list
• Isotope preset list
• Suitable for measuring vials and syringes
• User-definable containers
• Future dose calculation
• Vial/syringe preparation with patient information
• Quality control tests for the ionisation chamber:
• Molybdenum breakthrough measurement
• User-definable labels
• Touch screen control

3.1.12.3 Label printer

The IBC Dose Calibrator supports all printers that use Windows drivers. The labels can be defined by the user via a dedicated
tool in IBC-LITE that is easy to use.

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3.1.13 Smart Geiger GM probe

SMART GEIGER is a device for detecting radioactivity inside hot-cells. Its main
function is to lock the door when the dose rate rises above a pre-set alarm
threshold. Alternatively, the instrument can be used to monitor the outlet air
duct. In the event an alarm is triggered, the cell air inlet and outlet valves are
closed (optional supply). The alarm threshold can be set from the membrane
keyboard.
The device consists of a detector probe and counting electronics that allows
reading the measurements and managing the alarms. The radiation-sensitive
element (detection probe) is installed inside the cell, whereas the counting unit
is mounted on the panel.
The device has a beam-on signal inlet, which is used to turn off the probe high
voltage. This ensures a longer life of the Geiger.

CAUTION
The customer is responsible for the definition of a warning level which can guarantee operator safety.

3.1.14 Particle counter set-up

The work chamber and the pre-chamber are equipped with fittings with antistatic tubes connected with the testing
connection flange, to which a particle counter can be connected (optional).

3.1.15 AVCL: automatic ventilation closing system

Automatic ventilation closing system for chambers and/or pre-chambers

including set-up for sanitisation system with VPHP (Vapour-Phase Hydrogen
Peroxide) connected directly to the cell ventilation system and managed
separately from the chambers in decontamination. The system allows you to
automatically conduct the leak test inside each chamber in which it is installed.
AVCL entails:
Main chamber and pre-chamber isolation with the aim of periodical leak tests.
Support for the VPHP generator for bio-decontamination.
The system consists of:
2 pneumatically-actuated valves controlled from an HMI touch panel (4 with
pre-chambers) that isolate the cell.
2 manually-actuated valves (4 with pre-chambers) that exclude the VPHP
generator input and output.
INFORMATION
The decontamination system and its accessories (e.g. concentration sensors inside and outside the
chamber) are not included in this optional unit but must be purchased separately.
When the cell is coupled to a decontamination system (e.g. VPHP generator), the overall dimensions
resulting from the connections between the two systems must always be evaluated.

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3.1.16 CF18-T - Container to transport bottles with tungsten shielding

The CF 18 shielded container is in tungsten and is used to transport radioisotopes

vials.
The top is locked by means of a fixed joint (Bayonet catch). The lock is equipped
with an O-Ring seal that ensures a perfect tightness. The CF 18 shielded
container is also equipped with a built-in handle to enable easy transport.

3.1.17 SXC - Shielded container made of lead for syringes

Containers to transport Comecer 10 ml and 5 ml BD type syringes with

pierceable cap (equipped with or without PST shielding).
Series SXC containers are made of lead and covered in fibre-reinforced plastic
composite materials.
The total equivalent shielding (including the PST, if applicable) is 15 mm of lead.
The containers are closed by a threaded device and are equipped with a
stainless steel built-in handle for transport.
The type is distinguished by colour coding:
• S5C container for a 5 ml syringe with Comecer pierceable cap or needle* -
blue
• S5CP container for a 5 ml syringe with Comecer pierceable cap and PST shielding - light blue
• S10C container for a 10 ml syringe with Comecer pierceable cap - dark green
• S10CP container for a 10 ml syringe with Comecer pierceable cap and PST shielding - light green
* The S5C container can contain 5 ml syringes with maximum total needle length of 45 mm (including the Luer Lock fitting)

3.1.18 Software compliant with CFR21 part11 (Electronic records; electronic signatures)

The conformity of the software to the CFR21 part 11 norm is self-certified by

Comecer following documented analysis of the regulation’s requirements: how
these requirements are applied in the development of the software is described
here. The requirements relative to CF R21 part 11 are further validated by a test
protocol (STS Software test specifications).
The software is supplied with the following characteristics:
· Control and safety of operator access to the system.
· Audit trail
· Archiving and recovering archived data
· Electronic signature

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3.1.19 Automatic system for filter integrity test (Bubble Point Test)

A bubble point test is a test designed to determine the pressure at which a

continuous stream of bubbles is initially seen downstream of a wetted filter
under gas pressure. To perform a Bubble Point Test, gas is applied to one side
of a wetted filter, with the tubing downstream of the filter submerged in a
bucket of water. The filter must be wetted uniformly such that water fills all the
voids within the filter media. When gas pressure is applied to one side of the
membrane, the test gas will dissolve into the water, to an extent determined
by the solubility of the gas in water. Downstream of the filter, the pressure is
lower. Therefore the gas in the water on the downstream side is driven out of
solution. As the applied upstream gas pressure is increased, the diffusive flow
downstream increases proportionally. At some point, the pressure becomes
great enough to expel the water from one or more passageways establishing
a path for the bulk flow of air. As a result, a steady stream of bubbles should be
seen exiting the submerged tubing. The pressure at which this steady stream is
noticed is referred to as the bubble point.

The system allows to perform a non-destructive bubble point test to check filter integrity at the end of a batch production.
The test is performed by slowly increasing the pressure inside the filter, until rapid continuous bubbling is observed at
the outlet (a standard vial filled with saline or injectable water can be used for this purpose): at this point the operator has
to complete the test by requesting the appropriate finish command, and the pressure value will be recorded. Of course,
the accuracy of this test will also rely on the operator’s ability to successful recognize this point. The test can be started or
interrupted at any time by the user by requesting the appropriate start and abort commands. If the maximum test pressure
is reached, the cycle will automatically stop.
A pressure-controlled automated valve is used to regulate the gas pressure towards the filter.
The following parameters can be adjusted before starting the test:
• STEP PRESSURE: delta-value to be used for pressure increase during the cycle.
• TIME BETWEEN PRESSURE STEP UP: the amount of seconds to wait before increasing the pressure set-point of one step
value during the cycle.
• MAXIMUM TEST PRESSURE: when this value is reached at valve’s outlet, the pressure set point will be set to zero and
cycle will be interrupted.
A graph plots the real-time trend of both pressure set point value and pressure outlet value.
Manual commands are also available to manually perform the procedure or to test the functionality of the system.
A bubble point value lower than the specification is an indication of one of the following:
• fluid with different surface tension than the recommended test fluid
• integral filter, but wrong pore size
• high temperature
• incompletely wetted membrane
• non-integral membrane or seal

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3.2 RELATED PRODUCTS

3.2.1 GET: Vials fractioning system

The GET dispensing unit installed inside a COMECER BBST-PC cell allows
fractioning the FDG or other radiopharmaceutical doses in sterility conditions
in compliance with GMP standards.

For further information, consult the relative technical specification.

3.2.2 TIMOTHEO-LT: Vials fractioning system

The TIMOTHEO-LT system has been designed and manufactured to fill sterile
vials with radiopharmaceuticals without having to perforate the cap.
The system can be installed inside a COMECER laminar flow cell mod. BBST-
PC (class A). This combination ensures a production in compliance with GMP
standards

For further information, consult the relative technical specification.

3.2.3 ARGO: Automatic dispensing system for vials

ARGO system is an easy to operate semi-automatic vial dispensing product-line
for safe and accurate dispensing inside a hotcell cabinet. It is specially designed
for operation via manipulators, resulting in a robust and fail-safe dispenser.

For further information, consult the relative technical specification.

3.2.4 FEBO RP: Automatic dispensing system for syringes

FEBO-RP is a dispenser for safe and accurate fractionation of radiopharmaceuticals
in syringes. The device was made in full compliance to cGMP guidelines. It is
intended to introduce a quick and effective preparation process inside Nuclear
Medicine departments.
The capability of measuring dosage activity by means of an integrated ionising
chamber makes it as reliable as any standard dose calibrator.
FEBO can receive radiopharmaceuticals from a synthesis module and is
designed to be installed inside a hotcells.

For further information, consult the relative technical specification.

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4 TECHNICAL DATA
Support frame material Carbon steel treated with epoxy paints
External casing material AISI 304 - Scotch-BriteTM
Working chamber material AISI 316L - Mirror-Bright
Lead purity Title Pb 98% + Sb 2%
Electrical panel protection rating IP 54
Shielding (Pb) mm 75
Shielded glass dimensions mm 200 x 200 (l x h)
Weight kg 10000
Internal pre-chamber dimensions mm 555 x 740 x 495 (l x d x h)
Internal dimensions of the dispensing chamber mm 594 x 587 x 662 (l x d x h)
Internal dimensions of the synthesis chamber mm 635 x 680 x 675 (l x d x h)
External dimensions mm 2040 x 1090 x 2400 (l x p x h)(l x d x h)
For Europe
Main power supply 230V (1Ph+N+PE) | 50/60Hz | 16A TN-S
& similar
For North
Main power supply America & 208/120V (2Ph+N+PE(GND)) | 60Hz | 15A
similar

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4.1 VENTILATION AND FILTERS

Air classification: Class “A” with laminar flow (LAF) on the entire area
Air inlet: n°1 F9 filter
Dispensing chamber Laminar flow (LAF): n°1 H14 absolute filter
Air outlet: n°1 active carbon filter
Air flow rate: 100 m3/h

Air classification: Class “B”

Air inlet: n°1 H14 absolute filter
Pre-chamber for materials introduction
Air outlet: n°1 F9 filter
Air flow rate: 20 m3/h

Air classification: Class “B”

Air inlet: n°1 H14 absolute filter
Synthesis chamber
Air outlet: n°1 active carbon filter
Air flow rate: 20 m3/h

Air classification: Class “B”

Air inlet: n°1 H14 absolute filter
Drawing System for vials/syringes
Air outlet: n°1 active carbon filter
Air flow rate: 10 m3/h

Air classification: Class “B”

Air inlet: n°1 H14 absolute filter
Waste compartment
Air outlet: n°1 active carbon filter
Air flow rate: 10 m3/h

4.2 SHIELDINGS

Description Material Thickness (mm)

Calibrator compartment Pb 75
Radiofluids duct Pb 50
Work chamber/pre-chamber passage shielded door Pb 75
Synteshis chamber Pb 75
Dispensing chamber Pb 75
50
Waste compartment Pb
(frontal door 75)
Drawing System compartment Pb 50

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4.3 OVERALL DIMENSIONS

+5

+5
2040 0 MAX OVERALL DIMENSION
1090 MAX OVERALL DIMENSION
0
A

MAX OVERALL DIMENSION

B
468

662

747

+5
0
2549
SECTION A-A A

559 594
587
742

478
R
547 59
3
R 49
6

R 81
1

SECTION B-B

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5 WORK AREA DISINFECTION KIT

To achieve controlled microbiological contamination inside the machine it is essential to follow dedicated cleaning
procedures, based on precise and specific operator movements and products that are proven to be effective. Accordingly,
Comecer recommends using two kits, “Cleaning Kit - WIPES” and “Cleaning Kit - DISINFECTION”. The former contains cloths
with low particle release and the latter is comprised of specific work area disinfection products, duly accompanied by a
validation protocol, proving the effectiveness of the disinfectant on the most common surfaces in nuclear medicine/
radiopharmaceutical workshops (glass, plexiglass, pvc, steel, etc.).

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6 VALIDATIONS - FAT/SAT PROTOCOLS

According to the GMP requirements (Good Manufacturing Requirements), each manufacturer has the task of identifying the
validation steps which are necessary in order to prove that the critical aspects of his particular operation are under control.

6.1 MAIN STEPS OF VALIDATION:

• URS - User Requirement Specification (by User)
• DQ-Design Qualification (standard supply, can be covered in normal design reviews)
• FAT-Factory Acceptance Test (standard supply)
• SAT-Site Acceptance Test (standard supply)
• IQ-Installation Qualification (optional supply)
• OQ-Operation Qualification (optional supply)
• PQ-Performance Qualification (by User).
Comecer supply FAT (Factory Acceptance Test) validation protocols for every Hot Cell/Dispensing system/Isolator. Comecer
perform SAT (Site Acceptance Test) and supply if requested IQ & OQ protocols (Installation Qualification & Operational
Qualification). The validation protocols comply to the following standards:
• ISO 14644 (Clean-rooms and associated controlled Environments)
• ISO 10648 (Containment enclosures)
• EEC-GMP (Good Manufacturing Practice - Annex 1 Manufacture of sterile Medicinal Products)
• PDA -TR Nr 34 (Design and Validation of Isolator Systems for the Manufacturing and Testing of Health Care Products).

6.2 FAT (FACTORY ACCEPTANCE TEST)

The complete validation test for the equipment will be performed at Comecer’s site. The FAT protocol will include the
following tests:
• Test Instrument Data (Calibration Certificates of the reference instruments)
• System Documentation Verification (documents list for the equipment qualification)
• Construction Design Verification (“As Built drawings and schemes”)
• Main Equipment Specification Verification (correspondence with the design)
• Functionality/Interlocks Verification (Mechanical & Software)
• Glove Breach Test (only where gloves provided)
• Unidirectional Air Flow Verification (Smoke pattern test - only with Laminar flow)
• Air Change Rate
• Air Velocity Verification (only with Laminar flow)
• Filter Leakage (Integrity test)
• Leak tightness Test (only if applicable)
• Non Viable Particle Counts (Air classification).

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Fig. 1 Laminar Flow Air Velocity Fig. 2 Filter Leakage Fig. 3 Unidirectional Air Flow Verification
(Smoke pattern test)

Fig. 4 Glove Breach Test Fig. 5 Leak Tightness Test Fig. 6 Particle Counting Test (Air
Classification)

6.3 SAT (SITE ACCEPTANCE TEST)

The SAT will include the following tests:
• Finishing Visual check
• Main components visual check
• Internal box pressure and ventilation setting
• Utilities functionality and setting check
• Functionality/Interlocks Verification (Mechanical & Software)
• Hot test for dispensing systems (activity source supplied by Customer)
• Dose calibrator verification (activity source supplied by Customer)
• Safety devices and interlocks check
• Operator’s training
• Delivery of the performed FAT protocol and documentation package including:
•• Maintenance and User’s manual
•• Recommended spare parts list
•• Certificate of compliance
•• As built technical drawings (electrical, mechanical, pneumatic & process schemes)
•• Materials certificates/data sheets
•• Main equipments data sheets
•• Instruments calibration certificates
•• Welding Processes qualification.

6.4 OPTIONAL
6.4.1 IQ & OQ (Installation Qualification & Operational Qualification)
If requested, as an optional service , Comecer can perform IQ-OQ validation at customer’s site. The IQ-OQ validation will be
performed by qualified technicians (Comecer Validation Dept.) using calibrated instruments and the protocol will include
the complete tests list as performed during the FAT, repeated again at customer’s site.

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7 AFTER-SALES SERVICE

7.1 MAINTENANCE SERVICES

7.1.1 Preventative Maintenance

We carry out periodical checks on the appliances to prevent failures before they occur and to preserve and improve reliability.
Through measuring and diagnosis techniques of the machine, we can measure the real operating conditions of the single
components and of the equipment; therefore, we can recognise the components that start to wear in advance and plan
interventions according to the production requirements to guarantee maximum efficiency of the machine.

7.1.2 Corrective maintenance

Diagnosis: the corrective maintenance process starts with the diagnosis of the failure. During this phase, we will inspect the
system, use diagnostic instruments and interview the user. This is important to detect the problem and solve the cause and
not only “the symptoms”.
Intervention: in addition to the “on site” intervention, we can carry out interventions via remote connection (for automatic
systems) to minimise waiting time and machine downtime. Interventions aim at solving the problem definitively, with
solutions that go from replacing the failed component to machine upgrades to removing the cause of the failure.

7.2 REMOTE ASSISTANCE / HELP DESK

This service allows you to connect to Comecer’s computer to access all machine functions directly and check them for proper
operation.
Standard Maintenance Contract
Offer: Preventive maintenance + corrective maintenance (defined intervention time)
Full Risk: Preventive maintenance + corrective maintenance (defined intervention time) + spare parts.

7.3 TRAINING & CONSULTING

Training sessions for users (new users and refresh training) - Training for the customer’s technicians on first level maintenance.
We help our customers find the best solutions, ensuring that both the operating and financial goals are reached.

7.4 UPGRADE & RETROFIT

We propose constant updates on the equipment to increase durability and reliability both in terms of operational safety.

7.5 SPARE PARTS

Critical spare parts are always available in the dedicated Comecer warehouse.
Set of critical spare parts defined for each appliance.

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7.6 VALIDATION & IQ / OQ

DOP test for HEPA filters
Verification of particulate contamination (Classification).
Verification of one-way flow (smoke test – with laminar flow only)
Verification of one-way flow (with laminar flow only)

7.7 SERVICE AS A CONTINUOUS SUPPORT TO CUSTOMERS

From the SAT (Site Acceptance Test), Comecer Service takes care of its customers for the entire duration life of the equipment,
by supporting them either during the normal processing or maintenance operations or for extraordinary service.

7.8 IMMEDIATE RESPONSE TO THE REQUESTS OF THE CUSTOMER.

Our service engineering office handles over 1,000 worldwide technical support requests a year, either via telephone or on-
line.
Presence in the field
Comecer Field Engineers and autorized local Service Providers authorized and certified, manage over 1,500 interventions a
year, at the customer premises in short time, with high professionalism and expertise level in order to ensure top equipment
efficiency.

7.9 PLANNING
Our planning office ensures an optimized service planning, by assigning priority levels, according to the customer’s
requirements.

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8 INSTALLATION REQUIREMENTS
The customer is require to provide a number of pre-arrangements to install the equipment: for details refer to the specific
demo drawing for the configuration in question, provided separately.

8.1 NOTES REGARDING INSTALLATION

The photo below represents an example of the COMECER cells standard installation, as seen from the front side.
The external covering cases are not attached to the ceiling, as it can be seen from the photo. (A).

On customer request, COMECER will close the cells up to the ceiling.

On customer request the cell is made in order to ensure the air tightness between the laboratory and the technical area.

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 TD_BBST-COMBO-SERIES_R11_ENG – 21/02/19

The photo represents an example of the COMECER cells standard installation, as seen from the back side

C
B

STANDARD FRONT COVERINGS (see in the previous

A Parts supplied by COMECER:
image)
for the extraction of air, COMECER provides an air
B Parts supplied by COMECER:
extraction fan for every cell;
The connection of the radiofluids lines to the
C Parts not supplied by COMECER
COMECER cell valves is made by the customer;
The hidden parts of the cells (e.g. rear part) are not
D Parts not supplied by COMECER
covered by stainless steel coverings
If the cells are not against the wall, an access door is
E Parts supplied by COMECER on customer request
made in the rear area.

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NOTES:
©2018 COMECER S.P.A. | ALL RIGHTS RESERVED - TUTTI I DIRITTI RISERVATI
Via Maestri del Lavoro, 90 - 48014 Castel Bolognese (RA) Italy
http://www.comecer.com - E-mail: [email protected]
tel. (+39) 0546 656375 - fax (+39) 0546 656353

Part of COMECERGROUP