HELIOS

SHIELDED ISOLATOR WITH INTEGRATED DISPENSER FOR VIALS AND SYRINGES

TD_HELIOS_R5b_ENG – 31/08/21

ISO 9001 & ISO 13485 Certified Quality System

 TD_HELIOS_R5b_ENG – 31/08/21

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_HELIOS_R5b_ENG – 31/08/21

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........................................................................................................................................................................................ 9
1.4.1 EQUIPMENT AVAILABLE ON REQUEST...................................................................................................................................10

2 CONSTRUCTIONAL FEATURES............................................................................................................................................... 11
2.1 DESCRIPTION OF MAIN COMPONENTS.............................................................................................................................................11
2.2 MACHINE STRUCTURE..............................................................................................................................................................................14
2.2.1 STRUCTURE.......................................................................................................................................................................................14
2.2.2 COVERINGS.......................................................................................................................................................................................14
2.2.3 SHIELDING.........................................................................................................................................................................................14
2.2.4 SHIELDED GLASS WINDOW (IF PRESENT)............................................................................................................................14
2.2.5 AIR TIGHT SYSTEM..........................................................................................................................................................................14
2.2.6 DOORS................................................................................................................................................................................................15
2.3 VENTILATION................................................................................................................................................................................................16
2.3.1 MAIN CHAMBER..............................................................................................................................................................................16
2.3.2 MATERIALS INTRODUCTION PRE-CHAMBER.......................................................................................................................17
2.3.3 QUALITY OF THE AIR.....................................................................................................................................................................18
2.3.3.1 MAIN CHAMBER..............................................................................................................................................................................18
2.3.3.2 MATERIALS INTRODUCTION PRE-CHAMBER.......................................................................................................................18
2.3.3.3 DRAWING SYSTEM.........................................................................................................................................................................18
2.3.3.4 SOLID WASTE COMPARTMENT..................................................................................................................................................18
2.4 CONTROL PANEL.........................................................................................................................................................................................19
2.4.1 DATA TRANSFER..............................................................................................................................................................................19
2.4.1.1 DATA TRANSFER MODE LAY-OUT............................................................................................................................................20

3 OPERATIONAL FUNCTIONING............................................................................................................................................... 21
3.1 OPERATING PRINCIPLE.............................................................................................................................................................................21
3.2 STERILE KIT....................................................................................................................................................................................................24
3.3 DISPENSING FORMATS.............................................................................................................................................................................25
3.4 OTHER FEATURES AND BENEFIT...........................................................................................................................................................25

4 ACCESSORIES............................................................................................................................................................................ 26
4.1 MACHINE EQUIPMENT..............................................................................................................................................................................26
4.1.1 LED LAMPS FOR LIGHTING.........................................................................................................................................................26
4.1.2 LIGHT INDICATOR WITH BUZZER.............................................................................................................................................26
4.1.3 SHIELDED SEALED INLETS FOR RADIOFLUIDS...................................................................................................................26
4.1.4 SOFTWARE COMPLIANT WITH CFR21 PART11 (ELECTRONIC RECORDS; ELECTRONIC SIGNATURES).........26
4.1.5 SMART GEIGER GM PROBE.........................................................................................................................................................27
4.1.6 AVCL: AUTOMATIC VENTILATION CLOSING SYSTEM........................................................................................................27

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 TD_HELIOS_R5b_ENG – 31/08/21

4.1.7 CF18 - SHIELDED CONTAINER FOR VIAL TRANSPORT.....................................................................................................27

4.1.8 CF18-T - CONTAINER TO TRANSPORT BOTTLES WITH TUNGSTEN SHIELDING.....................................................28
4.1.9 SXC - SHIELDED CONTAINER MADE OF LEAD FOR SYRINGES......................................................................................28
4.1.10 PARTICLE COUNTER SET-UP.......................................................................................................................................................28
4.1.11 REMOTE PARTICLE COUNTER....................................................................................................................................................28
4.1.12 AUTOMATIC SYSTEM FOR FILTER INTEGRITY TEST (BUBBLE POINT TEST)..............................................................29
4.1.13 DOSE CALIBRATOR MOD. IBC DOSE CALIBRATOR............................................................................................................30
4.1.13.1 IONISATION CHAMBER, MODEL VIK-210...............................................................................................................................30
4.1.13.2 IBC DOSE CALIBRATOR.................................................................................................................................................................31
4.1.13.3 LABEL PRINTER................................................................................................................................................................................31
4.1.14 E-LABEL - AUTOMATIC VIALS LABELLING SYSTEM...........................................................................................................32
4.1.15 SOLID WASTE COMPARTMENT..................................................................................................................................................33

5 TECHNICAL DATA..................................................................................................................................................................... 34
5.1 VENTILATION AND FILTERS.....................................................................................................................................................................35
5.2 SHIELDINGS...................................................................................................................................................................................................35
5.3 OVERALL DIMENSIONS.............................................................................................................................................................................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_HELIOS_R5b_ENG – 31/08/21

1 OVERVIEW

1.1 OVERVIEW
HELIOS is a Class A shielded isolator equipped with laminar flow throughout the entire main chamber and with an integrated
fully automatic system for radiopharmaceuticals dispensing in asepsis, according to referred regulations for operators,
environment and products safety. Specifically, HELIOS is designed for radiopharmaceutical production center, laboratories
or hospitals following cGMP guidelines.
HELIOS dispenses radiopharmaceuticals in open vials, closed vials or syringes depending on the configuration of the
machine, ensuring the sterility conditions.
The integrated fully automatic dispenser is the faster dispensing system available in the market: it is designed to produce
batches of 50 syringes or vials with an avarage process speed dependent on the type of filling.

Cycle times
Closed vials (5ml) 40 sec Syringe with pierceable cap (5ml) 75 sec
Open vials, capped and crimped (5ml) 67 sec Vials or syringe with E-Label + 2 min

The system has features functions such as Bubble Point Test (BPT) execution for the dispensing filter, leak test of the
main chamber and pre chamber. Plus, the system can be equipped for dynamic air sampling, particle counting and VPHP
sterilisation cycle.
HELIOS can be provided with 75 or 100 mm lead shielding, thus guaranteeing radioprotection of the operators.

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 TD_HELIOS_R5b_ENG – 31/08/21

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 (pre chamber) with air quality complying with Class B “At rest” (EEC-cGMP) and equipped
with handling gloves
• Extraction system with Class B area provided with pass-through dose calibrator (2 Ci of F18)
• Air tight meet class 3 ISO 10648-2 (both in main chamber and pre chamber)
• Integrated fully automatic dispensing system in the main chamber
• Possibility to dispense in open vials, closed vials or syringes depending on the configuration of the machine
• 75 or 100 mm of lead shielding available
• Shielded and hinged front door of the main chamber equipped with lead glass
• Frontal hand doors for manipulation available for 75 mm shielding
• Hinged front door of the material input chamber made of Plexiglas and equipped with glove flanges
• Shielded side sliding door between material introduction chamber and dispensing chamber
• O
ptional waste compartment with air quality complying with Class B “At rest” (EEC-cGMP) equipped with front door for
extraction
• End product extraction system equipped with pass through dose with air quality complying with Class B “At rest” (EEC-
cGMP)
• Filtration system for main chamber and pre-chambers with HEPA H14 absolute filtering cartridge
• Air outlet filtration system made with active carbon filtering cartridge (excluding pre-chamber having a fine filter)
• 316L AISI stainless steel work chambers with Mirror-Bright internal surface finish, TIG continuous welds, and widely
rounded corners
• Shielding elements realised from primary ingots with Pb 98% + Sb 2% purity.
• Epoxy-coated carbon steel support structure
• 304 AISI stainless steel front coverings, easy to decontaminate, separates the laboratory area (front) from the technical
cabinet (rear)
• Operator panel to check and trace the critical parameters of the machine both in “at rest” or “in operation” mode
• Shielded entry for radioactive fluids
• Connection for DOP test (filter sealing test) for absolute filters
• Semi-automatic Bubble Point Test for the dispensing system
• Geiger-Muller probe to detect radioactivity inside the cell and door interlock management
• Set-up for connecting hydrogen peroxide generators (VHP) in the main chamber and in the pre-chamber
• Automatic leak test for main chamber and pre chamber
• Set-up for a particle counter sensor in the main chamber and in the pre-chamber

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 TD_HELIOS_R5b_ENG – 31/08/21

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)
• EN 60204-1:2006 Safety of machinery - Electrical equipment of machines - Part 1: General requirements (IEC 60204-
1:2005 (PEQ))
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
• GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems
• FDA CFR21 part 11

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 TD_HELIOS_R5b_ENG – 31/08/21

1.3 EQUIPMENT LINES

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

HELIOS 75 BASE MACHINE WITH GLASS

HELIOS 75 WITH GLASS, HAND PORTS AND SOLID WASTE

HELIOS 75 WITH GLASS, HAND PORT, SOLID WASTE AND E-LABEL

HELIOS 100 BASE MACHINE WITH GLASS

HELIOS 100 WITH GLASS AND SOLID WASTE

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 TD_HELIOS_R5b_ENG – 31/08/21

1.4 MAIN EQUIPMENT

MACHINE WITH GLASS

MACHINE WITH GLASS

GLASS, HAND PORTS
Models

GLASS, HAND PORT,

AND SOLID WASTE

SOLID WASTE AND

HELIOS 100 WITH

HELIOS 100 BASE
HELIOS 75 WITH

HELIOS 75 WITH
HELIOS 75 BASE

SOLID WASTE
E-LABEL
Main features
(included in configurated machine)

Shielding (mm Pb) 75 75 75 100 100

“Class B” material introduction side pre-chamber S S S S S
Integrated fully automatic dispensing system S S S S S
Hand ports on frontal shielded door - S S - -
Solid waste compartment - S S - S
Dose calibrator (bulk) S S S S S
Pass through dose calibrator (final product) S S S S S
E-Label (automatic vial labelling system) * - - S - -
Smart Geiger (internal environmental monitoring system) S S S S S
Bubble Point Test S S S S S
CFR21 licence PART 11 S S S S S
European electrical power supply R R R R R
American electrical power supply R R R R R
AVC Light (including set-up for VPHP with manual valve on the
S S S S S
VPHP line and leak test functionality)
LED lighting S S S S S
Buzzer with indication of machinery status S S S S S
Internal inlets for radiofluid capillaries S S S S S
Drawing System S S S S S
Final product extraction position
Front Drawing System drawer opening S S S S S
Rear Drawing System drawer opening - - - - -
Shielded container
Shielded container mod. CF18
S S S S S
(n°1 container included in basic supply)
Shielded container mod. CF18-T O O O O O
Shielded container mod. S5C O O - O O
Shielded container mod. S5CP
(n°1 container included in basic supply when selected accessory O O - O O
for filling 5ml syringes)
Shielded container mod. S10C O O - O O
Shielded container mod. S10CP
(n°1 container included in basic supply when selected accessory O O - O O
for filling 10ml syringes)

* With the E-Label option is only possible to deliver vials (syringes are not supported)
S= Standard; O= Option; R= Configurable when placing order

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 TD_HELIOS_R5b_ENG – 31/08/21

1.4.1 Equipment available on request

MACHINE WITH GLASS

MACHINE WITH GLASS

Models

GLASS, HAND PORTS

GLASS, HAND PORT,

AND SOLID WASTE

SOLID WASTE AND

HELIOS 100 WITH

HELIOS 100 BASE
HELIOS 75 WITH

HELIOS 75 WITH
HELIOS 75 BASE

SOLID WASTE
E-LABEL
Available accessories
(to be quoted separately)

Setup for custom vials (Other from the standard 10ml vials) * R R R R R
Setup for naked syringes with removable cap
R R - R R
(Only one single format supported)*

Setup for extra naked syringes with removable cap* R R - R R

Setup for 5ml naked/PST syringes with pierceable
R R - R R
septum*
Setup for 10ml naked syringes/PST with pierceable
R R - R R
septum*
Integrated particle counter R R R R R

Integrated microbiological sampler R R R R R

Custom vial lead or tungsten container support O O O O O

SSC syringes container support O O - O O

Custom syringe container support O O - O O

* This setup includes the supply of 5 syringe (or vial) holders

S= Standard; O= Option; R= Configurable when placing order

INFORMATION
Each accessory component in this table is quoted separately as an offer item added to the price listing
of the configured machine.

INFORMATION
In the basic configuration of Helios, the supply of 10 holders for 10ml vials is always provided.

INFORMATION
To reach the maximum batch capacity (50) it is necessary to separately purchase an appropriate
number of holders in the required format combination.

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 TD_HELIOS_R5b_ENG – 31/08/21

2 CONSTRUCTIONAL FEATURES

2.1 DESCRIPTION OF MAIN COMPONENTS

All installed parts are defined by the selected configuration

1 13

12

2 11

4 10

9
5

8
6

Ref. Description Ref. Description

1 Main chamber and prechamber air inlet grille 8 Solid waste compartment front door
2 Connection test compartment 9 Main chamber shielded door
3 Material transit pre-chamber (Airlock) 10 Shielded glass window
4 Touch screen operator panel 11 Emergency stop button
5 Label printer 12 Main chamber environmental monitoring display
6 Lower technical compartment 13 Buzzer with indication of machinery status

7 Drawing System front door

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 TD_HELIOS_R5b_ENG – 31/08/21

1 16

2 15

3 14

4 13

12
5

11
6

10
7
9
8

Ref. Description Ref. Description

1 Laminar air flow filters 9 Waste compartment
Product discharge duct with pass through
2 Smart geiger probe 10
ionization chamber
3 System for filling open/closed vials 11 Waste discharge duct
4 Main chamber / prechamber connection tunnel 12 Bulk ionization chamber hole
5 Barcode reader unit 13 Dispensing unit
6 Conveying system for vials and syringes 14 Actuator unit for vials management
Actuator unit for syringes management and
7 15 Shielded sealed inlets for radiofluids
vials/syringes discharge
Laminarflow sensor and temperature/humidity
8 Product extraction system 16
probe

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 TD_HELIOS_R5b_ENG – 31/08/21

1 6

5
2

Ref. Description
1 Pre-chamber
2 Preset for Particle Counter
3 Sliding tray
4 Inflatable gasket
5 Materials transfer door
6 Utilities plate

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 TD_HELIOS_R5b_ENG – 31/08/21

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 (if present)

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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 TD_HELIOS_R5b_ENG – 31/08/21

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.
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 system is equipped with functional interlock for opening, dependent on
internal radioactivity monitoring system of the machine.
In the lower area of the door (depending on the configuration of the machine)
there are two panels for the hands that allow you to perform manual tasks by
exposing the operator to limited radiation.

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.

Waste compartment door

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.

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 TD_HELIOS_R5b_ENG – 31/08/21

2.3 VENTILATION

2.3.1 Main chamber

3
1

2 4

Inlet flow

Outlet flow

Filters

The upper wall of the main chamber has two absolute filters that cover 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 two fans (Ref. 3), which
recirculate the air through the absolute filter (Ref. 1). The flow is directed downwards in a vertical direction, therefore, it flows
out from the main chamber through a special fissure located along the rear wall of the same chamber (Ref. 5) and returns to
the fan through a return air manifold (Ref. 4).
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 (± 30%) 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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2.3.2 Materials introduction pre-chamber

Inlet flow

Outlet flow

Filters

The upper wall of the material input pre-chamber has an H14 absolute filter. Air is pushed by a fan and filtered before
being input into the pre-chamber with a turbulent flow that ensures Class B, according to EEC-GMP guidelines. Before being
expelled, the air is filtered by means of a F9 fine filter.

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 TD_HELIOS_R5b_ENG – 31/08/21

2.3.3 Quality of the air

2.3.3.1 Main 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%.

2.3.3.2 Materials introduction 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

2.3.3.3 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

2.3.3.4 Solid 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

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 TD_HELIOS_R5b_ENG – 31/08/21

2.4 CONTROL PANEL

The equipment has a 20” touch-screen operator control panel 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 1000 parameters with
relevant warnings and alarms for complete control of the equipment and its
components.

There are 1024 password levels and an unlimited number or operators available, runtime manageable according to CFR21
part 11 for complete traceability of who has carried out operations on the equipment.
The operator panel saves all sensitive data in a log file in the project folder; such files can be exported via the USB port or via
Ethernet.

2.4.1 Data transfer

Critical data can be exported according to the following modes:

1- Standard: USB port on the front of the cell - laboratory side - within the “test
connection compartment” (see fig.)
2- On request: ethernet connection from the PLC to transfer the instantaneous
values; receiving and storing these value will be made by the customer’s system
(PC, SCADA, ...).
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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 TD_HELIOS_R5b_ENG – 31/08/21

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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 TD_HELIOS_R5b_ENG – 31/08/21

3 OPERATIONAL FUNCTIONING

3.1 OPERATING PRINCIPLE

The hot cell is equipped with a fully automatic system in the main chamber, able to provide a complete ad aseptic GMP
dispensing process on vials and syringes.
The integrated fully automatic dispensing system is the faster dispensing system available in the market: it is designed to
produce batches of 50 syringes or vials. Each cycle includes dispensing, calibration (in the pass-through ionization chamber),
discharge in the shielded container and extraction.

Conveyor positioned
underneath the hot cell floor

INFORMATION
The maximum number of syringes that can be loaded on a single batch is 50 (size of 5ml). The maximum
number of vials that can be loaded on a single batch is 50 (size 15ml).

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The dispensing system consists of the following parts:

1) An “invisible” conveying system (image A) for vials and syringes, where vials and syringes are placed on the work table
of the cell inside magnetic containers and moved to allow filling and unloading in a sequential and fast way.
A magnetic transport system (image B) is placed under the worktop which, thanks to the correspondence of a magnet
under the work surface for each magnetic container positioned above the plane, allows the transport of the containers
and therefore of vials and syringes.

A) 50 vials or 50 syringes path B) Magnetic transport system

2) Two actuators units with electric grippers for vials and syringes. The first actuator unit (image C, ref. 1) move vials from
the conveying system to the filling systems and back; the second one (image C, ref. 2) moves vials from the conveying
system to the pass-through calibrator (image C, ref. 3), and moves syringes from the conveying system to the filling
system and then to the pass-through dose calibrator.
3) Two barcode readers, one to read the label of the vials or syringes, and one to identify the transport holder before filling
(image C, ref. 4).
4) A system for filling open or closed vials (image C, ref. 5)), consisting of:
• a crimping station
• an aluminium ring pick and place station
• a rubber stopper pick and place station
• open filling station with underneath scale (image C, ref. 6). A needle is used for open filling and a scale is placed as
gravimetric feedback. The scale can be used also for a “post filling” weight check.
• closed filling station (without underneath scale). A needle is used to piece the vial for the filling.
5) A filling system for syringes (image C, ref. 7), consisting of:
• a filling station for Comecer syringes, with a top down connection for the GEMINI connector
• a rotation system able to remove and place (screwing) the luer-lock cap of common syringes (not Comecer syringes)
with filling station for common syringes, with a direct connection on the luer.

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4 5 1

2 7 3 6 8
C) Dispensing system

Inside the main chamber there is also a special ionization chamber provided
with and integrated scale and a magnetic stirrer (optional). The ionization
chamber is able to detect up to 20 Ci of F18. The design of the area will allow the
positioning of a 500 ml glass bulk. A magnetic stirrer integrated in the ionization
chamber, if present as option, will allow to execute the homogenization of the
radiopharmaceutical without the risk of bubbles in the fluid. The gas mixing
anyway is always possible.
The dispensing system can receive radiopharmaceuticals from a multidose
vial or a synthesis module. In any case the radiopharmaceuticals are loaded in
the bulk (mother vial) with a maximum capacity of 500 ml, indirectly from the
multidose vial or directly from the synthesis module.
Near the ionization chamber is positioned the peristaltic pump (image C, ref.
8) that allows a pre-dilution of the bulk, analysis of the radiopharmaceuticals
concentration by weight / activity and another dilution if needed.
The pre-dilution and dilution are made with an NaCl saline (isotonic) solution
and mixed using a technical gas (bubble mixing) or magnetic stirrer.
The concentration is evaluated measuring the radioactivity through the dose
calibrator and the weight through the scale.
Concentration and dilution analysis can take place at the beginning or even in
the middle of the dispensing process.
The integrated dispensing system ends with pass-through ionization chamber and the discharge system. The pass-through
ionization chamber is able to detect up to 2 Ci of F18. After the calibration, the final product is discharged in the final
container. Connection between the pass-through ionization chamber and the extraction compartment is made with sealed
mechanisms. After discharge, the operator can proceed with the extraction (after container closure if needed).

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3.2 STERILE KIT

The disposable kit is an essential part of the system.
The system is designed for use with a disposable kit which is easy to position.
The composition of the kit can change according to the type of filling to be carried out: only vials, only syringes, vials and
syringes, with bulk dilution, etc.
The full configuration is described below:

1 2 3
4

14
6

8
13

12

11 10 9 4

Ref. Description Ref. Description

1 Sterilising idrofilic filter 0.22µm 8 Bulk with inlet straw
2 Radiofluid syringe pump 9 Syringe pump for saline solution
3 Technical gas connection 10 Valve ramp for saline solution management
4 Spike for saline solution bag connection 11 Valve ramp for radiofluid management
5 Peristaltic pump tube for bulk dilution 12 Dispensing needle for saline solution vial filling
6 Radiofluid arrival connection 13 Double-needle perforator for syringe filling
7 Sterilising idrofobic filter 0.22µm 14 Dispensing needle for radiofluid vial filling

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3.3 DISPENSING FORMATS

The dispensing system is designed to dispense radiopharmaceuticals in the following formats:
• 10 ml to 30 ml ISO 20 open vial followed by crimping.
• 10 ml to 30 ml ISO 20 closed vial by piercing the rubber cup (transseptal).
• 5 ml to 10 ml not shielded common syringes to be capped after dispensing (models to be defined and validated in the
machine before approval)
• 10 ml not shielded syringe (Comecer) with pierceable cap (Comecer KIT GEMINI B). The PST can be present in the final
container and the extraction system will place the syringe in the shielding
• 5 ml not shielded syringe (Comecer) with pierceable cap (Comecer KIT GEMINI B). The PST can be present in the final
container and the extraction system will place the syringe in the shielding
The common syringes are standard syringes available in the market and equipped with a luer-lock connector and an un-
screwable closing cap. The syringes will be managed by the system always without tungsten shielding.
The syringes with pierceable cap are the standard Comecer KIT GEMINI B syringes. The PST can be present in the final
container and the extraction system will place the syringe in the shielding.
In the same batch is possible to dispense:
• Open vials of different capacity (between the supported capacity listed above);
• Closed vials of different capacity (between the supported capacity listed above);
• Syringes with Comecer pierceable cap of different capacity (between the supported capacity listed above);
• Syringes with luer lock connection of different capacity (between the supported capacity listed above);
• Vials (open or closed) and syringes (with Comecer cap or with luer lock connection), between the supported capacity
listed above – pre-sales avaluation needed.
To perform the format change is possible to intervene with adapters placed by the operator, but without the need for
mechanical adjustments or complex software adjustments. Every adaptor is an accessory and it is not included in the
standard configuration.

3.4 OTHER FEATURES AND BENEFIT

Disposable kits for dispensing will be introduced with double envelope through the hot cell pre-chamber
The dispensing system is provided with disposable kits, removable and mountable through gloves. The disposable will be
made of PVC in the basic version, but also in PTFE version suitable for radiopharmaceuticals for brain scanning.
The dispensing system is designed to support the final sterilization through 0,22 µm filter.
The above operations shall be carried out in conformity with the cGMP guidelines.
A filter integrity test (bubble point test) can be carried out at the end of each batch using technical gas. It is possible to
perform an inline bubble point test on filters, using a semi-automatic “bubble presence” approach or a completely automatic
approach only in the case of non-ventilated filters.
The dispensing system is able to manage different type of labels and to print them during the dispensing process.

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4 ACCESSORIES

4.1 MACHINE EQUIPMENT

All installed parts are defined by the selected configuration

4.1.1 LED lamps for lighting

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

4.1.2 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.

4.1.3 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.

4.1.4 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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4.1.5 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.

4.1.6 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.

4.1.7 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.

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4.1.8 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.

4.1.9 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)

4.1.10 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).

4.1.11 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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4.1.12 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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4.1.13 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.

4.1.13.1 Ionisation chamber, model VIK-210

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-210 ionisation chamber is pressurised at 1.4 bar (absolute) of Argon and its range of measurement is up to 20Ci (74
GBq) of F-18.

Ionisation chamber Pressurised (1.4 bar abs. Argon)

Ionisation voltage 150 V lithium battery
Well size Ø 69 mm x 280 mm
Well liner (inside) Ø 57 mm x 270 mm
>2000 GBq (Tc-99m), >700 GBq (F-18)
Saturation
>60 Ci (Tc-99m), >20 Ci (F-18)
Energy range 25 keV - 3 MeV
Lead shielding 3 mm Pb
Linearity ± 1 % between 50 MBq and 700 GBq (Tc-99m)
Electrometer accuracy ±1%
HV test accuracy ±5%
Temperature coefficient 0,1%/°C between 10°C and 40°C at 5 MBq and up
Reproducibility ± 1% over 24 hours, stable conditions
± 3 % dependant of specific calibration source and
Overall accuracy
geometric variations
Response time Maximum 2 seconds for 95% of the end value
Isotope factor Digital adjustment
Gain Digital adjustment
Bias correction Digital adjustment
Zero adjustment Digital adjustment
Calibration Digital adjustment
Background subtraction Digital control
High voltage test Digital control
Interface Ionisation chamber interface
Power supply 5 VDC, 250 mA
Cable 2.5 meters
Dimensions Ø 150 mm (bottom Ø 160 mm) x 451 mm height
Weight 15.5 kg

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4.1.13.2 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 2.5

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

4.1.13.3 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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4.1.14 E-Label - Automatic vials labelling system

This equipment has been designed and manufactured for the automatic labelling over sealed vials filled with radiotracers,
used in PET (Positron Emission Tomography) and SPECT (Single Photon Emission Computed Tomography) diagnostics as well
as of generic radiopharmaceuticals for therapy, and discharged with Comecer Pass Throgh dose calibrator.
Comecer eLabel features a thermal transfer printing head to quick transfer data over laminated labels, an automatic label
applier and the interface with vial delivery system, everything inside a compact metal frame.
eLabel allows the application of the correct amount of activity, calibration time, expiry date and further production
information, collected after the dispensing.

Printing system

Unibody tape cassette

CAUTION
When E-Label is installed, HELIOS cannot deliver syringes. With the E-Label option is only possible to
deliver vials..

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4.1.15 Solid Waste compartment

The machine can be equipped with a large shielded waste compartment (50 mm Pb) connected to the main chamber by
means of a sealed duct. The duct and the waste compartment are independent chambers ventilated from HEPA H14 inlet
and outlet filters (Class B).
Access to the discharge duct from the main chamber is through a shielded hinged door equipped with an inflatable gasket.
In the waste area a plastic 12-litre bin is placed (standard container for hospital waste), able to accommodate an entire
disposable kit set at the end of dispensing.
The cover of the bin is placed in a special housing by the operator during the machine’s set-up phase. The waste area has a
shielded door (equipped with an inflatable gasket) on the front side of the cell. The operator will place the cover on the waste
container before its extraction.
Usually the two isolated chambers are kept in increasing depressions with respect to the main chamber. In this way there is a
system for the isolation of waste with a double chamber for maximum product safety in GMP optic and at the same time for
the containment of the radioactive.

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5 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%
Shielding (Pb) mm 75 100
Shielded glass dimensions (if present) mm 200 x 200 (l x h) NA
Weight kg 11780 13800
Internal pre-chamber dimensions mm 555 x 740 x 495 (l x d x h)
Internal dimensions of dispensing chamber mm 930 x 725 x 635 (l x d x h)
External dimensions mm 2000 x 1290 x 2400 (l x d x h)
Electrical panel protection rating IP 54
For Europe &
Main power supply 230V (1Ph+N+PE) | 50/60Hz | 20A TN-S
similar
For North America
Main power supply 208/120V (2Ph+N+PE(GND)) | 60Hz | 20A
& similar
Operating temperature °C 15 ÷ 35
Operating humidity % < 90 non condensing
Technical gas supply (He / N) bar 5
Minimum operating pressure bar 6
Compressed air consumption
Nl/min ~100
(with operating pressure 6 bar)
Volume of the saline solution ml 100 ÷ 500
Type of containers to be filled Open vials, closed vials, syringes
Dispensing method open vials Weight feedback
Dispensing method closed vials or syringes Volumetric dispensing
Minimum volume dispensed ml 0.5 (closed vial or syringe) | 0.3 (open vial)
Maximum volume dispensed ml vial or syringe max acceptable volume
0.5 ÷ 1 ± 0.05
Volumetric dispensing accuracy ml
>1 ± 5%
Bulk maximum total volume ml 500
Glass bulk with silicon tight connector cap and peek
Bulk type
draw capillary
Overall final dose accuracy (open vial) % ≥ 0.3 ml +/- 10% on the target dose
Overall final dose accuracy (closed vial or 0.5 – 1 ml +/- 15% on the target dose
%
syringe) > 1 ml +/- 10% on the target dose
4 ml (divided into 1 ml on the bottom of the glass
Residual volume at the end of the dispensing
bulk and 3 ml along the tubes)
Closed vials (5ml) 40
Open vials, capped and crimped (5ml) 67
Cycle time sec
yringes with pierceable cap (5ml) 75
Vials or syringe with E-Label + ~ 120

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5.1 VENTILATION AND FILTERS

Air classification: Class “A” with laminar flow (LAF) on the entire area
Air inlet: 1 H14 absolute filter
Main chamber Laminar flow: 2 U15 absolute filters
Air output: Active carbon filter
Air flow rate: 200 m³/h
Air classification: Class “B”
Air inlet: H14 absolute filter
“Class B” material introduction side pre-chamber
Air outlet: F9 pre-filter
Air flow rate: 10 m³/h
Air classification: Class “B”
Air inlet: H14 absolute filter
Drawing System
Air outlet: Active carbon filter
Air flow rate: 5 m³/h
Air classification: Class “B”
Air inlet: H14 absolute filter
Solid waste compartment
Air outlet: Active carbon filter
Air flow rate: 5 m³/h

5.2 SHIELDINGS

Thickness for 75 mm Thickness for 100 mm

Description Material
models (mm) models (mm)
Upper shielding Pb 75 100
Lateral shielding Pb 75 100
Rear shielding Pb 75 100
Front shielding Pb 75 100
Shielded front door Pb 75 100
Shielded glass Pb 75* 100*
Lower shielding Pb 75 100
Calibrator compartment Pb 75 100
Radiofluids duct Pb 50 50
Pre-chamber / main chamber passage shielded door Pb 75 100
Waste compartment Pb 50 50
Drawing System duct Pb 50 50
* Value equivalent to a hypothetical lead thickness

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5.3 OVERALL DIMENSIONS

1270

2400
1800

1440
1260
880

1164 2000
1870

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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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Laminar Flow Air Velocity Filter Leakage Unidirectional Air Flow Verification (Smoke
pattern test)

Glove Breach Test Leak Tightness Test 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_HELIOS_R5b_ENG – 31/08/21

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:
©2021 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