FHR-SSC

HOOD WITH LAMINAR FLOW

TD_FHR-SSC_R6_ENG – 03/08/17

ISO 9001 & ISO 13485 Certified Quality System

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TD_FHR-SSC_R6_ENG – 03/08/17

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_FHR-SSC_R6_ENG – 03/08/17

INDEX

1 OVERVIEW.....................................................................................................................................................................................4
1.1 REFERENCE STANDARDS........................................................................................................................................................................... 5

2 CONSTRUCTIONAL FEATURES..................................................................................................................................................6
2.1 DESCRIPTION OF MAIN COMPONENTS............................................................................................................................................... 6
2.2 MACHINE STRUCTURE................................................................................................................................................................................ 7
2.2.1 CONSTRUCTION FEATURES............................................................................................................................................................... 7
2.2.2 WORK AREA.............................................................................................................................................................................................. 7
2.2.3 QUALITY OF THE AIR............................................................................................................................................................................. 8

3 TECHNICAL DATA........................................................................................................................................................................9
3.1 OVERALL DIMENSIONS.............................................................................................................................................................................10

4 ACCESSORIES............................................................................................................................................................................ 11
4.1 STANDARD SUPPLY....................................................................................................................................................................................11

5 WORK AREA DISINFECTION KIT ........................................................................................................................................... 12

6 VALIDATIONS - FAT/SAT PROTOCOLS.................................................................................................................................. 13

6.1 MAIN STEPS OF VALIDATION:.................................................................................................................................................................13
6.2 FAT (FACTORY ACCEPTANCE TEST)......................................................................................................................................................13
6.3 SAT (SITE ACCEPTANCE TEST)................................................................................................................................................................14
6.4 OPTIONAL......................................................................................................................................................................................................15
6.4.1 IQ & OQ (INSTALLATION QUALIFICATION & OPERATIONAL QUALIFICATION)............................................................15

7 AFTER-SALES SERVICE............................................................................................................................................................ 16
7.1 MAINTENANCE SERVICES........................................................................................................................................................................16
7.1.1 PREVENTATIVE MAINTENANCE......................................................................................................................................................16
7.1.2 ON CALL MAINTENANCE..................................................................................................................................................................16
7.2 REMOTE ASSISTANCE / HELP DESK......................................................................................................................................................16
7.2.1 MAINTENANCE CONTRACTS OFFER............................................................................................................................................16
7.3 TRAINING & CONSULTING.......................................................................................................................................................................16
7.4 UPGRADE & RETROFIT..............................................................................................................................................................................16
7.5 UPGRADE & RETROFIT..............................................................................................................................................................................16
7.6 SPARE PARTS.................................................................................................................................................................................................16
7.7 VALIDATION & IQ / OQ..............................................................................................................................................................................17
7.8 SERVICE AS A CONTINUOUS SUPPORT TO CUSTOMERS............................................................................................................17
7.9 IMMEDIATE RESPONSE TO THE REQUESTS OF THE CUSTOMER..............................................................................................17
7.9.1 PRESENCE IN THE FIELD....................................................................................................................................................................17
7.10 PLANNING......................................................................................................................................................................................................17

8 INSTALLATION REQUIREMENTS............................................................................................................................................ 18
8.1 NOTES REGARDING INSTALLATION.....................................................................................................................................................18

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TD_FHR-SSC_R6_ENG – 03/08/17

1 OVERVIEW
Laminar flow hood for preparations under aseptic conditions “not radioactive”. It guarantees the protection for the materials
and the product whilst maintaining sterility.
The hood is conceived for the preparation and manipulation of materials and products which must be carried out in asepsis,
therefore in room with class A with laminar flow. It’s characterized by laminar vertical flow on the work bench. The entering
air is filtered via a HEPA filter.
When the hood is switched on, the air inside the room is extracted via the grill placed at the base of the frontal opening and
passes under the work bench. After passing through the HEPA filter it then enters from the top of the work chamber with a
vertical flow at parallel running, with constant speed from 0,36 to 0,54 m/sec (guide value GMP - Annex1) in the working area.
The air quality of the hood FHR SSC has characteristics such as to be classified in class “A”. The hood can be used for the
introduction of the materials in the farmaceutical production lines and for the management of the reagents of the synthesis
modules in radiochemistry.
The quantity of the particles in the air corresponds to the characteristis required for the class ISO 5 (EN 14644-1), class A (GMP
- Annex1) and for the critical zones: ≤ 3.500 particles/m3 with ø ≥ 0,5 μm.

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TD_FHR-SSC_R6_ENG – 03/08/17

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)
The product was designed in compliance with the following requirements:
• Eudralex - Volume 4 Good Manufacturing Practices (GMP) Guidelines.

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TD_FHR-SSC_R6_ENG – 03/08/17

2 CONSTRUCTIONAL FEATURES

2.1 DESCRIPTION OF MAIN COMPONENTS

5
6
4
1
2

A
SEZIONE A-A

Ref. Description
1 Plexiglas panel (10 mm thick)
2 Plexiglas side panels (10 mm thick)
3 Perforated work surface
4 HEPA filter (laminar flow)
5 Air inlet fan (laminar flow)
6 HEPA filter obstruction control pressure gauge
7 Technical compartment (electric board)

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TD_FHR-SSC_R6_ENG – 03/08/17

2.2 MACHINE STRUCTURE

2.2.1 Construction features

The hood features a front opening that allows air to enter and a vertical laminar flow on the work surface; the inlet air is
filtered by a HEPA filter. When the hood is switched on, the air in the room is sucked from the grid at the base of the front
opening. It passes under the work surface and, after going through the HEPA filter, is sent from above into the work chamber
with a vertical flow in parallel currents at a constant speed between 0.36 and 0.54 m/s (GMP guideline value - Annex1) into
the work area.
The air quality of the FHR SSC hood can be classified in class “A”. The hood can be used to insert materials in pharmaceutical
production lines and to manage reagents in radiochemical synthesis modules.

2.2.2 Work area

The work area is completely made of AISI 304 stainless steel with Scotch-BriteTM surfaces.
All the joints are made using the “arc” welding technique and are cut and polished in an inert gas atmosphere. The entire
structure is strengthened with box-section stainless sheet steel.
The work surface is made up of perforated AISI 316L stainless steel that is completely removable for elimination of
contaminated elements. The perforation makes it also possible to recuperate the air that returns to the air extraction fan via
a stainless steel collector. The hood has a frontal acrylic door (10 mm thickness) and on the sides, two clear acrylic panels
(thickness 10 mm).

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TD_FHR-SSC_R6_ENG – 03/08/17

2.2.3 Quality of the air

The FHR SSC hood is equipped with a ventilation system that can create a controlled contamination area. The fan sucks the
air from the room and pushes it inside the plenum which contains the absolute filter: it is filtered by an H14 HEPA filter with
99.995% efficiency measured on the particle with higher penetration (MPPS) as required by Standard EN 1822. The speed of
the air leaving the perforated diffuser panel below the HEPA filter allows (thanks to vertical Plexiglas panels mounted on the
hood) a laminar flow with total protection from airborne contamination.
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%.

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TD_FHR-SSC_R6_ENG – 03/08/17

3 TECHNICAL DATA
Frame material AISI 304 - Scotch-BriteTM
Working chamber material AISI 316L - Mirror-Bright
Electrical panel protection rating IP 54
Frontal closing Plexiglass, with compass opening
Air velocity m/s 0.36 - 0.54
Total nominal air capacity m3/h 594
Air inlet filter type Absolute (HEPA)
HEPA filter efficiency % 99,995 (H14)
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_FHR-SSC_R6_ENG – 03/08/17

3.1 OVERALL DIMENSIONS

932
A

770
2400

392
1800
1000

1000

A SEZIONE A-A
1230

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TD_FHR-SSC_R6_ENG – 03/08/17

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

4.1 STANDARD SUPPLY

• Lighting with one or more LED lamps
• Filter clogging control pressure gauges
• Frontal connection for filter leak test
• Compartment with hinged doors
• Key lock
• Centrifugal fan for extraction air

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TD_FHR-SSC_R6_ENG – 03/08/17

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_FHR-SSC_R6_ENG – 03/08/17

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_FHR-SSC_R6_ENG – 03/08/17

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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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

Prevent the failure of equipment before it actually occurs and preserve and enhance equipment reliability by replacing worn
components before they actually fail.

7.1.2 On Call Maintenance

Diagnosis: the process of corrective maintenance begins with a failure and a diagnosis of the failure. The diagnostic process
can include a physical inspection of a system, the use of a diagnostic computer to evaluate the system, interviews with
system users. It is important to determine what caused the problem in order to take appropriate action.
Action: on site or by remote access (only for automatic systems). Inspection of the equipment to identify the reason of failure
and the action to be taken to eliminate or reduce the frequency of future similar failures.
Testing: technician verifies that the fix problem has been fixed by testing the system.

7.2 REMOTE ASSISTANCE / HELP DESK

The service allows connecting to the Comecer computer to access directly all machine functions and verify their proper
operation.

7.2.1 Maintenance Contracts offer

• Standard: preventive maintenance + ON CALL (secured lead time).
• Full Risk: preventive maintenance + ON CALL (secured lead time) + Spare parts.

7.3 TRAINING & CONSULTING

Additional training for users.
Level 1 maintenance training.
Helping the customer to find the best solution ensuring that both operational and economical needs are optimally met.

7.4 UPGRADE & RETROFIT

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

7.5 UPGRADE & RETROFIT

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

7.6 SPARE PARTS

Critical Spare Parts always available
Comecer warehouse.
Stock of parts as close to customers as possible using service providers warehouses.

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7.7 VALIDATION & IQ / OQ

DOP test for HEPA filters.
Particle Counting test.
Laminar Flow Air Streams Test (visual inspection).
Laminar Flow speed test.

7.8 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.

7.9 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.

7.9.1 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.

7.10 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.
It is the customer’s responsibility to check that the doors, corridors and worktops of the laboratory allow the passage of the
largest component during the installation phase.
The correct installation of the machine requires the presence of floor plan, stable and level.

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

C
B

A Parts supplied by COMECER: STANDARD FRONT COVERINGS

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:
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©2017 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