FHR1-50

HOOD FOR MANIPULATIONS AT MEDIUM ACTIVITY

TD_FHR1-50_R7_ENG – 12/01/18

ISO 9001 & ISO 13485 Certified Quality System

 TD_FHR1-50_R7_ENG – 12/01/18

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_FHR1-50_R7_ENG – 12/01/18

INDEX

1 OVERVIEW.....................................................................................................................................................................................5
1.1 REFERENCE STANDARDS........................................................................................................................................................................... 6

2 CONSTRUCTIONAL FEATURES..................................................................................................................................................7
2.1 DESCRIPTION OF MAIN COMPONENTS............................................................................................................................................... 7
2.2 SHIEDINGS LAYOUT..................................................................................................................................................................................... 9
2.3 MACHINE STRUCTURE..............................................................................................................................................................................10
2.3.1 MATERIALS USED.................................................................................................................................................................................10
2.3.2 STRUCTURE............................................................................................................................................................................................10
2.3.3 COVERINGS.............................................................................................................................................................................................10
2.3.4 SHIELDING..............................................................................................................................................................................................10
2.3.5 SHIELDED GLASS WINDOW.............................................................................................................................................................10
2.4 WORK AREA...................................................................................................................................................................................................10
2.5 VENTILATION................................................................................................................................................................................................11
2.5.1 MAIN COMPONENTS..........................................................................................................................................................................11

3 ACCESSORIES............................................................................................................................................................................ 12
3.1 STANDARD SUPPLY....................................................................................................................................................................................12
3.2 ACCESSORY DESCRIPTION .....................................................................................................................................................................12
3.2.1 LED LAMPS FOR LIGHTING..............................................................................................................................................................12
3.2.2 TECHNICAL GAS CONNECTIONS...................................................................................................................................................12
3.2.3 SHIELDED SLIDING FRONT PROTECTION - BMI.......................................................................................................................12

4 TECHNICAL DATA..................................................................................................................................................................... 13
4.1 OVERALL DIMENSIONS.............................................................................................................................................................................14

5 WORK AREA DISINFECTION KIT ........................................................................................................................................... 15

6 VALIDATIONS - FAT/SAT PROTOCOLS.................................................................................................................................. 16

6.1 MAIN STEPS OF VALIDATION:.................................................................................................................................................................16
6.2 FAT (FACTORY ACCEPTANCE TEST)......................................................................................................................................................16
6.3 SAT (SITE ACCEPTANCE TEST)................................................................................................................................................................17
6.4 OPTIONAL......................................................................................................................................................................................................18
6.4.1 IQ & OQ (INSTALLATION QUALIFICATION & OPERATIONAL QUALIFICATION)............................................................18

7 AFTER-SALES SERVICE............................................................................................................................................................ 19
7.1 MAINTENANCE SERVICES........................................................................................................................................................................19
7.1.1 PREVENTATIVE MAINTENANCE......................................................................................................................................................19
7.1.2 CORRECTIVE MAINTENANCE..........................................................................................................................................................19
7.2 REMOTE ASSISTANCE / HELP DESK......................................................................................................................................................19
7.3 TRAINING & CONSULTING.......................................................................................................................................................................19
7.4 UPGRADE & RETROFIT..............................................................................................................................................................................19
7.5 SPARE PARTS.................................................................................................................................................................................................19
7.6 VALIDATION & IQ / OQ..............................................................................................................................................................................20
7.7 SERVICE AS A CONTINUOUS SUPPORT TO CUSTOMERS............................................................................................................20

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 TD_FHR1-50_R7_ENG – 12/01/18

7.8 IMMEDIATE RESPONSE TO THE REQUESTS OF THE CUSTOMER..............................................................................................20

7.9 PLANNING......................................................................................................................................................................................................20

8 INSTALLATION REQUIREMENTS............................................................................................................................................ 21
8.1 NOTES REGARDING INSTALLATION.....................................................................................................................................................21

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 TD_FHR1-50_R7_ENG – 12/01/18

1 OVERVIEW
Workstation for the breakdown of the airborne radioisotopes coming from the manipulation of the volatile liquid or gas
substances.
Completely made from 1.5mm thick AISI 304 stainless steel with Scotch-BriteTM finish. Designed in accordance with the
current Radioprotection standards.
Supporting structure made in AISI 304 stainless steel.
The frame is supported on feet that can be automatically levelled and adjusted in height with a polyamide-supporting base.

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 TD_FHR1-50_R7_ENG – 12/01/18

1.1 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)
• EN IEC 61010-1:2010 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1:
General requirements
• EN 61326-1:2013 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General
requirements (IEC 61326-1:2012)
The product was designed in compliance with the following requirements:
• Eudralex - Volume 4 Good Manufacturing Practices (GMP) Guidelines.

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 TD_FHR1-50_R7_ENG – 12/01/18

2 CONSTRUCTIONAL FEATURES

2.1 DESCRIPTION OF MAIN COMPONENTS

1
1
4

2 5

Ref. Description
1 Upper technical compartment
2 Technical gas valve control
3 Sliding shielded glass window
4 Pressure gauges for filter obstruction
5 Internal lighting control
6 Electrical panel technical compartment
7 Lower technical compartment

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 TD_FHR1-50_R7_ENG – 12/01/18

2 3

6
7

9
8
10

Ref. Description
1 Air extractor duct (extraction fan not included)
2 Active charcoal filter (canister with barrier bag)
3 Absolute filter (canister with barrier bag)
4 LED lamp
5 Electrical socket
6 Technical gas connection
7 Technical duct
8 Lower technical compartment
9 Electrical board
10 Shielded duct for radio-fluids arrival

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 TD_FHR1-50_R7_ENG – 12/01/18

2.2 SHIEDINGS LAYOUT

1 4
B B
2

SECTION A-A A

SECTION B-B

Description Material Thickness (mm)

Shielded glass window Lead glass 50*
Front shielding Pb 50
Work surface shielding Pb 50
Rear shielding Pb 50
Lateral shielding Pb 50

* Value equivalent to an hypothetical thickness of lead

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 TD_FHR1-50_R7_ENG – 12/01/18

2.3 MACHINE STRUCTURE

2.3.1 Materials used

Building the machine completely in AISI 304 stainless steel allows for fast removal of external contamination and durability.

2.3.2 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 Scotch-BriteTM 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.

2.3.3 Coverings
All external coverings are realised completely in AISI 304 stainless steel with Scotch-Brite TM finishing.
Upon request of the customer, the cell can be made in order to ensure the airtight system between laboratory and technical
compartment.

2.3.4 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.

2.3.5 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.

2.4 WORK AREA

A connection hole to the lower technical compartment is available on the

worktop. This connection can be used as a passage for the capillary tubes and
to discharge waste materials by inserting a special container for waste in the
lower technical compartment. Furthermore, it can be used as a passage for the
radioactive fluids with a connection from the floor by means of a lead duct, with
30 mm thickness.
Connections for the technical gases and electrical sockets are available in the
work area.
Two precision pressure gauges for the continuous measurement of the filter
obstruction (absolute filter and active charcoal filters) and the switch to turn on
the internal lights and the controls for the manual valves that open/close the
technical gases are located on the front upper part of the hood.

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 TD_FHR1-50_R7_ENG – 12/01/18

2.5 VENTILATION
Suction and filtering unit for the removal of airborne radioisotopes (particulate or gas). The system is dimensioned to
maintain a flow speed of the front entry air of 50 ± 20% cm/sec.

2.5.1 Main components

Main components

Hepa H13 efficiency MPPS 99.95%

dimensions: 149 x 610 x 305 (w x d x h)
Absolute Filter
rated air capacity: 600 m3/h
initial loss of load: 250 Pa

Dimensions: 298 x 610 x 305 (w x d x h)

Active Charcoal
rated air capacity: 650 m3/h
filter:
initial loss of load: 100 Pa

The absolute filter and the active charcoal filter are in

Canister an air-tight housing fitted with a barrier bag for the safe
replacement of filters.

The efficiency of the filters is continually monitored by two

Control system
pressure gauges on the front upper part of the hood.

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 TD_FHR1-50_R7_ENG – 12/01/18

3 ACCESSORIES
The machine is provided with a complete supply of accessories

3.1 STANDARD SUPPLY

• Lighting with one or more LED lamps
• Filter clogging control pressure gauges
• Technical gas connections
• Electrical power supply sockets
• BMI - Shielded sliding front protection

3.2 ACCESSORY DESCRIPTION

3.2.1 LED lamps for lighting

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

3.2.2 Technical gas connections

Every chamber is equipped with 3 1/8” (3.175 mm) AISI 316 stainless steel gas
supply lines with ball shut-off valves equipped with command handwheels
and gas identification plate and with 1 6 mm AISI 316 stainless steel gas supply
line with ball shut-off valves equipped with command handwheels and gas
identification plate.
The respective manual valves, used to control passage of the technical gases,
are located on the front of the equipment.
NOTE: the number of connections can vary according to the configuration of
the equipment.

3.2.3 Shielded sliding front protection - BMI

This front protection shielded with lead is specifically designed to protect

operators when they perform manual operations. It is equipped with a shielded
glass window.
When not in use, BMI protection can be placed internally on the side of the front
opening.

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 TD_FHR1-50_R7_ENG – 12/01/18

4 TECHNICAL DATA
Frame material AISI 304 - Scotch-BriteTM
Working chamber material AISI 316L - Scotch-BriteTM
Electrical panel protection rating IP 54
Lead purity % Pb ≈ 98%+ Sb ≈ 2%
Weight kg 2800
Overall dimensions mm 1500 x 850 x 2560 (w x d x h)
Work area dimensions mm 1300 x 600 x 800 (w x d x h)
Total nominal air capacity m3/h 650
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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 TD_FHR1-50_R7_ENG – 12/01/18

4.1 OVERALL DIMENSIONS

850
A

B B
800

2560
SECTION A-A A
1500

1300
600

SECTION B-B

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 TD_FHR1-50_R7_ENG – 12/01/18

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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 TD_FHR1-50_R7_ENG – 12/01/18

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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 TD_FHR1-50_R7_ENG – 12/01/18

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.

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 TD_FHR1-50_R7_ENG – 12/01/18

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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 TD_FHR1-50_R7_ENG – 12/01/18

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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 TD_FHR1-50_R7_ENG – 12/01/18

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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 TD_FHR1-50_R7_ENG – 12/01/18

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_FHR1-50_R7_ENG – 12/01/18

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: comecer@comecer.com
tel. (+39) 0546 656375 - fax (+39) 0546 656353

Part of COMECERGROUP