User Requirement Specification
                  Comprehensive specification of requirements
BEIJING MEDICAL FACTORY clean room, rooms 01-09

Project			Gambro
Cleanroom			MED-03
URS identification			project_CR_BEIJING MEDICAL FACTORY_URS_01
Prepared By Process Engineer:
István Varga
Initials:	Date:			Signature:
Reviewed By Technical Flow Manager:
Károly Szép
Initials:	Date:			Signature:
Reviewed Production Flow Manager:
Ottó Steiner
Initials:	Date:			Signature:
Reviewed By Quality Assurance:
Tibor Montovay
Initials:	Date:			Signature:
Approved By Production Director:
Bart Nolden
Initials:	Date:			Signature:
Approved By Key Account Manager:
Balázs Döbör
Initials:	Date:			Signature:
Approved By Quality Director:
István Czaba
Initials:	Date:			Signature:
Distribution:
Original to:		WSS > Production Documents > Gambro > belső dokumentumok > validációs dokumentumok > Clean Room			Q-P archive>Gambro > belső dokumentumok > validációs dokumentumok > Clean Room
Paper copy to:		Quality organisation
Electronic copy to:		WSS > Production Documents > Gambro > belső dokumentumok > validációs dokumentumok > Clean Room

 

1PURPOSE

The purpose of this document is to specify the requirements for the premises, the air management, and the equipment to be installed in BEIJING MEDICAL FACTORY. The requirements must be compatible with the GMP and with the requirements concerning security, the environment and health. We have specified these requirements in such a manner that they should correspond to the requirements imposed by projects, users and the quality assurance department.

1.1      Scope

The premises are intended to be used for the production injection moulded components for medical technical products for Nolato.
The requirement specification includes requirements for manufacturing hall, sluice gates and finished product packaging rooms, dressing rooms. The requirements cover construction, air management and equipment-related issues.
The injection moulding hall must be fit for injection moulding, in compliance with the effective URS.
This means that all equipment should be scaled in such a manner that on average, it should be possible to work with 30 injection moulding machines of 50-160 tons (clamping force).

1.2      Project background

-       The hall should be adjusted so that production with maximum intensity could take place there, with max15 persons in each shift. In the first step 6 IM machine will be set up.  The hall should also be able to be used for a different scenario, when production  are running with summ 30 machine  with more packaging and product management.
Both scenarios have been calculated for continuous operation (4 shifts 7 day/week).
-       The input material for injection moulding is different types of plastic raw materials.

2         SYSTEM OVERVIEW

2.1      Interface/responsibility

·                    The lighting and interior fittings required for a process are covered by the specifications for the respective processes.
·                    The building contractor is responsible for making holes and joints in the roofs, walls, doors and the floor.
·                    The building contractor is responsible for the placement of the fresh- and exhaust air apertures in the halls after consultation with Nolato.
·                    HEPA-filters must be handled, installed and tested by staff members having the requisite qualification.
·                    The existing Monitoring system (Control and Monitoring System) must control (regulate) the air management equipment so that it operates in line with the air technical parameters described in this requirement specification.
·                    A Monitoring -system must continuously monitor and record critical air technical parameters under its control.
·                    The building contractor is responsible – after consulting Nolato - for the placement of the compressed air and other gas outlets, the connections in the cleanroom and the air sluices.

2.2      System description

 
BEIJING MEDICAL FACTORY cleanroom
Definitions:
White Zone: The part of the clean room ISO 8 having no connection with the uncontrolled area (BEIJING MEDICAL FACTORY CLEAN ROOM-01, and CLEAN ROOM-02)
Grey Zone: Adjacent or connecting rooms that have connection with clean room and the uncontrolled areas such as warehouse, sluice gates, dressing rooms etc.
The raw material for injection moulding coming from outside the cleanroom by an automatized centralized material system in a closed pipeline system. The centralized material system should have the possibility to make use of a scanner system with locks to prevent errorous material handling. 
 The packaging materials supplied from the central warehouse into the material handling area “grey zone” side, from the “grey zone”, the plastic bags go into the “white zone” through a sluice gate. The plastic bags go into the production area from the white zone.
In the production area BEIJING MEDICAL FACTORY-01 goods are packed in single palstic bags and plastic boxes as temporaly storage or according to customer requirements. In these boxes, the final goods leave BEIJING MEDICAL FACTORY-01 through a sluice gate (goods air shower). Here, the goods are packed according to customer requirements and the finished package (in closed cardboardboxes or similar) go out to the central warehouse.

2.3      Specification of room, air management and equipment

 
·                    The input components of the hall, the air management system and the equipment must be designed with a view to hygiene and ergonomics, so that cleaning and tidying etc. should be easy.
·                    All input components in the classified halls must be designed, adjusted and shaped to meet the requirements of the hall’s cleanliness level.
·                    All components in the cleanroom must complie to MSZ-EN-ISO 14644 and withstand cleaning with common cleaning agents like 70 % Iso-propil-alkohol, Bendurol Forte, Molarsolv EV07, 70%-os etil-alkohol, GERMIMED, VANTROPOL, MEDONAL

2.4      Critical parameters influencing processes and products

The following parameters have a direct influence on the process and consequently on product safety and quality:
·                    Electricity
·                    Compressed air pressure
·                    Water cooling/pressure
 
None of these parameters will be verified in connection with the facility validation. They will be validated in the equipment validation process.
 
The following systems have an indirect influence by way of creating the environment in which the product is produced, or are used as assistance tools in the process.
·                    Ventilation (temperature, relative humidity and the number of particles and micro-organisms)
·                    Compressed air
·                    Tap water (hand washing) and drain
 

2.5      Interface to other systems

·                    Monitoring system (Monitoring system) for ventilation and equipment in Nolato Beijing Medical factory needs to be installed.
·                    Existing water and drain system have been expanded and needs to be installed
·                    A separate transformator will be supplying  the clean room area

2.6      Accessible equipment

None of the existing equipment will be used

2.7      Environment, health and safety

• Work environment, minimise noise (≤ 85 dB (A))  from the systems and the machines.
• Fire classification for whole cleanroom have to “D”
• Emergency exit have to built in

 

2.8      Layout/drawings

The layout and the drawings were given separately.

2.9      Life cycle

The facility and all components must follow a life cycle including its every phase, i.e. design/construction, installation, validation, use and removal. This means that all design documents must be updated during the whole life cycle, so that they should always reflect the real layout and function of the facility. The following documents are included:
·                    URS
·                    Room function programme
·                    Drawings and sketches
·                    Technical building descriptions (construction documents)
·                    Traceability matrix
·                    Other design documents
 
The documents must be available in the appropriate version and shall be approved. This means that the following approved documents must be available:
·                    Before installation/the start of the construction (including the construction documents)
·                    Before validation
·                    After validation (including the “as built” documentation)
·                    After changes in the course of usage
 
In order for the documents to be traceable and well under control, all changes must take place in a well-controlled manner. See bracket 11
 

3         LIMITATIONS

This document includes only the requirements imposed by operation. This document does not cover financial or legal aspects related to procurement/procurement procedure.
 

4         DEFINITIONS AND ABBREVIATIONS

This part presents the definitions and abbreviations used in this document.

4.1        ABBREVIATIONS

RK/EG	Cleanliness category/ Environmental grade
EU GMP	European Commission Good Manufacturing Practices
ISO	International Organization for Standardization
GMP	Good Manufacturing Practice
GEP	Good Engineering Practice
OEL	Occupational Exposure Limit
HEPA-filter	High Efficiency Particle Air- filter
RFP	Room function programme

 

4.2    Definitions

See the Nolato instruction Terms and abbreviations in the validation process

4.3      Cleanliness categories /environmental grades and environmental requirements

The requirements for the number and size of the particles in the classified halls are found in EN ISO-14644-1 “Cleanroom-associated controlled environments Part 1- Classification of air cleanliness” Methods for design, operation, testing and monitoring are found in ISO-14644-2 to ISO-14644-5. A vocabulary can be found in ISO-14644-6. Requirements for the testing and monitoring of microorganisms are found in ISO-14698-1 and 2.
The BEIJING MEDICAL FACTORY shall meet ISO14644-1, min. class 8 in operation, in and “as built”  and “at rest” state. Microbiological requirements shall be met “as built”, according to 44/2005.X 10.19 EüM rendelet melléklete (GMP Eudralex, volume 4, Annex 1, class D).
The process requires controlled temperature and humidity in the production halls.

5         CLASSIFICATION OF REQUIREMENTS

In order to be able to differentiate between the different requirement types, we have rendered a code to every requirement, as stated below:
I= information that gives information but cannot be tested.
1= Nolato’s own internal requirements
Internal requirements related to. e.g. the environment, health and safety. These should not be tested formally, but verified against the Good Engineering Practice during – for example – the review.
2= GMP requirement
GMP requirements related to e.g. product safety, requirements in the ISO standard or requirements imposed by the authorities must be tested (qualified/validated) formally against the GMP, producing a testing protocol.
3= Non-GMP requirement
Non-GMP requirements related to e.g. construction-technology should not be tested or verified, but handled according to the tendering procedure.
 

6          OPERATIONAL AND FUNCTIONAL REQUIREMENTS VENTILLATION

6.1        Monitoring systems

6.1.1       General

Requirement no.	Description	Code
6.1.1.1	A monitoring system must monitor the air management equipment according to the air technical parameters presented in this requirement specification.	I

 

6.1.2       Alarm functions

Requirement no.	Description	Code
6.1.2.1	In the Monitoring system it must be possible to set warning and alarm levels for critical parameters specified in this requirement specification.	2
6.1.2.2	The Monitoring system must continually monitor, alarm and log the critical parameters that are controlled by the Monitoring system. Critical parameters must be logged every 10 minutes.	2
6.1.2.3	Information about the alarm levels, delays and logging frequency is found in annexes (hall function programme for halls)	I
6.1.2.4	The alarm functions in the Monitoring system must be reviewed in consultation with NOLATO and shall be approved by NOLATO.	I
6.1.2.5	In the event of power breakdown or other disruption of the critical alarm, a visual alarm must be activated by the Monitoring system .	2
6.1.2.6	Alarms must be registered in the alarm lists, and it must be possible to print them out from the Monitoring system.	2

       

6.1.3       Control/interlocks

Requirement no.	Description	Code
6.1.3.1	The differential pressure must be maintained by controlling exhaust air (dampers & valves in the ventilation channels)	3
6.1.3.2	Fresh air must maintain the turnover requirements imposed, normally constant.	2
6.1.3.3	In the event of power breakdown or interruption of service of the air handling unit, air flow directions must not be reversed.	2
6.1.3.4	In the event of power breakdown of service, air flow directions must be kept by closing a spring loaded latch.	2
6.1.3.5	The New cleanroom plc controller should controll the humidity	3

 
 

7         TECHNICAL REQUIREMENTS

7.1        Clean room

7.1.1       General requirements surface materials

Requirement no.	Description	Code
7.1.1.1	The surface must withstand common cleaning with chemical agents, 70 % Iso-propil-alkohol, Bendurol Forte, Molarsolv EV07, 70%-os etil-alkohol, GERMIMED, VANTROPOL, MEDONAL, INTOMILD .The chemical certificate confirming this must be enclosed to the documentation.	2
7.1.1.2	Surfaces must be visibly smooth and without any visible cracks or holes.	2
7.1.1.3	All connections between the walls, floor, roof and installations must be joined together tightly.	2
7.1.1.4	Floor: Epoxi (silica infused), Grey (Or similar colour Polyurethane) in the whole BEIJING MEDICAL FACTORY.	3
7.1.1.5	Exposed surfaces may not be of wood, chipboard, plywood, paper or cardboard.	2
7.1.1.6	The walls must have  powder coated, smooth surface (inner surface) Kingspan panel (or similar)	2
7.1.1.8	All materials used must be described in data sheets and specifications enclosed to the documentation.	2
7.1.1.9	Avoid horizontal and tilted surfaces as much as possible to make cleaning easy.	2
7.1.1.10	The installation of electricity, pipes and data cables must be hidden in the walls as much as possible or must be outside the room.	2

 

7.1.2      Ceiling

Requirement no.	Description	Code
7.1.2.1	The surface must withstand common cleaning with chemical agents, 70 % Iso-propil-alkohol, Bendurol Forte, Molarsolv EV07, 70%-os etil-alkohol, GERMIMED, VANTROPOL, MEDONAL, INTOMILD. The chemical certificate confirming this must be enclosed to the documentation.	2
7.1.2.2	Surfaces must be visibly smooth and without any visible cracks or holes.	2
7.1.2.3	The ceiling shall be a self carry construction, passable from the top (200kg/m2)	3
7.1.2.4	All joints between ceilings, walls, must be joined and sealed.	2
7.1.2.5	Eventual equipment must simply be drawn through an opening in the roof. Transits must be sealed.	2
7.1.2.6	All media must be drawn above the ceiling and in the service corridors.	2
7.1.2.7	For joining together, always use mould-resistant material.	2
7.1.2.8	Specification/data sheet for how to use the joining material must be enclosed to the documentation.	2
7.1.2.9	All materials used must be described in data sheets and specifications enclosed to the documentation.	2
7.1.2.10	The plates in the ceiling must be white.	3

7.1.3       Walls

Requirement no.	Description	Code
7.1.3.1	The surface must withstand common chemical cleaning agents, like 70 % Iso-propil-alkohol, Bendurol Forte, Molarsolv EV07, 70%-os etil-alkohol, GERMIMED, VANTROPOL, MEDONAL, INTOMILD. The chemical certificate confirming this must be enclosed to the documentation.	2
7.1.3.2	Surfaces must be visibly smooth and without any visible cracks or holes.	2
7.1.3.3	All materials used must be described in data sheets and specifications enclosed to the documentation.	2
7.1.3.4	All joints between the wall elements, roof, floor, doors and windows must be joined together tightly.	2
7.1.3.5	For joining together, always use mould-resistant material.	2
7.1.3.6	Specification/data sheet for how to use the joining material must be enclosed to the documentation.	2
7.1.3.7	All eventual equipment must simply be drawn through an opening in the wall. Cable transits must be sealed.	2
7.1.3.8	The floors must be drawn up onto the walls with a wedge having a holker to the room.	2
7.1.3.9	Exhaust air apertures must be installed and joined into the wall.	2

7.1.4       Doors

Requirement no.	Description	Code
7.1.4.1	Doors must close tightly against the floor, the ceiling and the walls when shut.	2
7.1.4.2	Doors must be constructed in a way that makes them fulfill the requirements set for cleanrooms ISO 14644 Materials of the doors must be plastic or metal. Doors must be equipped with safety glass windows.	2
7.1.4.3	All materials used must be described in data sheets and specifications enclosed to the documentation.	2
7.1.4.4	Doors must have an auto-close function.	2
7.1.4.5	The doors should open into the rooms with the highest differential pressure. The differential pressure must help the door close. Deviations may be allowed if the layout so requires. If needed it must be checked if the door/s really close/s if the air management system is in full operation.	2
7.1.4.6	Doors of the sluices leading to production halls must be interlocked with an interlock system.	2
7.1.4.7	Thresholds may not be present on floors.	2
7.1.4.8	Doors with windows must be even with the door panel.	2
7.1.4.9	Door fittings must be designed in such a way that there are no sharp parts or places that are difficult to clean.	2
7.1.4.10	All joints between the door and the wall elements must be joined and sealed.	2
7.1.4.11	For joining together, always use mould-resistant material.	2
7.1.4.12	Specification/data sheet for how to use the joining material must be enclosed to the documentation.	2
7.1.4.13	Fast moving door towards the non controlled  area from the grey zone of the pack area.	2

7.1.5     Windows

Requirement no.	Description	Code
7.1.5.1	It must not be possible to open the windows.	2
7.1.5.2	The Materials of the windows must be plastic or metal materials	2
7.1.5.3	All materials used must be described in data sheets and specifications enclosed to the documentation.	2
7.1.5.4	The windows must be even with the wall elements in the clean room.	2
7.1.5.5	All joints between the windows and the wall elements must be joined and sealed.	2
7.1.5.6	The windows must be placed in the walls between the different rooms of the clean room and from the injection moulding area to the service corridors.	3

 

7.1.6     Floor

Requirement no.	Description	Code
7.1.6.1	The floor must bear a load of 2 tons in a point (2t/100cm2)	3
7.1.6.2	Material: Epoxi, Grey (Or similar colour Polyurethane). With holker against all walls.	2
7.1.6.3	All materials used must be described in data sheets and specifications enclosed to the documentation.	2
7.1.6.4	The surface must be free of pores. (fulfill the cleanroom requirement ISO 14644 )	2
7.1.6.5	The floor must be drawn up on the walls with a wedge that forms a holker with the room.	2

7.1.7       Lighting

Requirement no.	Description	Code
7.1.7.1	The luminaries must be fit and sealed to the ceiling, closed system, easy to clean and must withstand cleaning agents.	2
7.1.7.2	All materials used must be described in data sheets and specifications enclosed to the documentation.	2
7.1.7.3	The fluorescent lamps must be made of safety glass and may not be of the “starter” type (fire hazard).	2
7.1.7.4	Luminosity in BEIJING MEDICAL FACTORY should be 800 ± 10% Lux in the centre of the production hall without daylight. At the outer edges of the production halls the luminosity must not be lower than 450 Lux. The luminosity must be measured at 1500 mm from the floor with calibrated measuring instrument, and a copy of the calibration certificate of the measuring instrument must be enclosed.	2

7.1.8       Electronic connecting points and computer outlets

Requirement no.	Description	Code
7.1.8.1	All materials used must be described in data sheets and specifications enclosed to the documentation.	2
7.1.8.2	The 400V and the 240V sockets must be installed with as few protruding details as possible, and that is it possible to wipe them off with a wet cloth.	2
7.1.8.3	Cat. 6 Screened cables in the production spaces, but not in the offices	3

7.1.9     Heating systems

Requirement no.	Description	Code
7.1.9.1	Heating is maintained by the air management equipment.	3
7.1.9.2	Radiators are not allowed inside the clean room	2

7.1.10Sluice gates  

7.1.10.1   Staff sluice gates

Requirement no.	Description	Code
7.1.10.1.1	All entries and exits of the personnel must be through the personnel sluices.	2
7.1.10.1.2	Sluice gates must be equipped with an interlock system. (See Interlock spec).	2
7.1.10.1.3	There must be clear definitions /markings between the different sluice steps (grey zone- white zone).	2
7.1.10.1.4	The white zone of the sluice must have ISO8 category in operation.	2
7.1.10.1.5	The grey zone of the sluice must have ISO 8 category as built	2
7.1.10.1.6	The staff and material sluice gates must be separate	3
7.1.10.1.7	The lowest height of the internal roof must be 2.5 meters	3
7.1.10.1.8	The staff sluice gates must not have any wall windows towards the external corridors.	3
7.1.10.1.9	Every door in the sluice gate must have windows allowing the sight of the next room.	3
7.1.10.1.10	Personnel sluices must be equipped with wash basins that are connected to the sewage system of the building. These must have a back-lock design to prevent odour etc from the sewage system.	2
7.1.10.1.11	Soap-, disinfectant-, and towel dispensers must be set up at the wash basins.	2
7.1.10.1.12    S	There must be a mirror in the sluice.	2

 

 

7.1.10.2   Material sluice gate

Requirement no.	Description	Code
7.1.10.2.1.	All in- and outbound transportation of materials and equipments must be carried out through the material sluice.	2
7.1.10.2.2.	The air shower of the sluice area must conform with ISO8 category class for operation.	2
7.1.10.2.3.	There must be well defined areas for clean and less clean materials in the sluice, (markings on the floor etc.).	2
7.1.10.2.4.	All sluices must have interlocking doors. (See Interlocs spec).	2

7.2        Air management

7.2.1       General requirements for air management units    

Requirement no.	Description	Code
7.2.1.1	The air management unit must be designed with a view to hygiene, which includes: ·         Easy to assemble components for easy cleaning and maintenance ·         Fully flat inside and outside surfaces ·         Sealed panel joints ·         Large inspection doors ·         Extensible filter walls ·         F9 pre filter in the machine	I
7.2.1.2	The BEIJING MEDICAL FACTORY must meet the requirements for particles set by ISO14644-1 class 8  “as built” & “at rest” and “in operation” in white zone and “as built” and “at rest” in grey zones.	2
7.2.1.3	All materials used must be described in data sheets and specifications enclosed to the documentation.	2
7.2.1.4	The installation must be carried out in such a way that it is easily accessible for cleaning and maintenance.	2
7.2.1.5	The installation must be carried out in such a way that areas around (sides and above) are easily accessible as far as possible.	2
7.2.1.6	The cleaning agents specified by supplier must be approved by NOLATO: The specification of the cleaning agent used must be enclosed to the documentation.	2
7.2.1.7	Drainage of parts of the unit and the components thereof must be possible. Drainage sumps must slope towards the sewer.	3
7.2.1.8	Drainage function has to be controlled and documented prior to approval. Enclose signed and dated minutes to the air management documentation.	2
7.2.1.9	It must not be possible for water to gather in corners or dirt catchers and become stagnant in parts of the air handling unit.	2
7.2.1.10	Filtering in the air management unit must be carried out two steps: outdoor air goes through a fine filtration process, with the filter class being F5  F7 and goes out trough a F9 towards the room intake HEPA filters.	2
7.2.1.11	Assembled filters and filter class must be documented in a dated and signed protocol which is attached to the documentation of air management.	2
7.2.1.12	The filter edges and the filter bars must be sealed. Control is carried out visually and a dated and signed test protocol is attached to the documentation on air management.	2
7.2.1.13	Filters must not rest on the floor of the air management unit. Visually inspect and enclose a dated and signed test protocol to the air management documentation.	2
7.2.1.14	Pressure tests must be carried out on the air management unit and its components. Air handling units and its components must be made and sealed in such a way that they meet the requirements for class B tightness (described in for example VVS AMA 98 - General description of materials and works in the field of Building Services). A dated and signed proof of pressure tests must be attached to the documentation on air management.	2
7.2.1.15	The components of the dampers must be designed ISO 16…. requrements (with a view so that microbiological growth that could contaminate the air management components or the system is prevented. )	2
7.2.1.16	All parts of the air handling unit must be cleaned before the unit is put into service. Cleaning must be confirmed and documented.	2
7.2.1.17	Air management takes place with recirculated air, 70% is internal air.	2
7.2.1.18	Jointing can only be done by using a mildew resistant jointing compound. All materials used must be described in data sheets and specifications enclosed to the documentation.	2
7.2.1.19	Energy recycling takes place with heat exchanger.	3
7.2.1.20	Install HEPA filter (H14) in the end of the system in the clean room BEIJING MEDICAL FACTORY.	2
7.2.1.21	Include nipples to feed in the test aerosol in units equipped with a HEPA filter or where a HEPA filter can be installed.	2
7.2.1.22	It should be possible to install a pipe with an external diameter of 6 mm .	2
7.2.1.23	The placing and marking of the nipples must be documented in the drawings.	2
7.2.1.24	The requirement for the sealing test of the HEPA-filter (H14) and its fixture is <0.05 %. The upstream concentration of the test aerosol must be at least 10 µg/l. (A higher concentration may be required for stable measurement). Test aerosol must be Emery 3004 or something equivalent regarding particle size. The testing method should be approved according to ISO 14644 and EN 1822 standards.	2
7.2.1.25	The upper limit value for the HEPA filter differential pressure must be possible to register in the Monitoring system, and the exceeded limit value will activate the alarm.	2
7.2.1.26	It must be possible to measure the pressure differential of F9	2
7.2.1.27	The air handling unit and all critical components thereof must be marked with specific, clear and hygienic labels.	2
7.2.1.28	HEPA filter (H14) is to be supplied with a filter certificate. The filter certificate must at least indicate the serial number, the filter class, the test method, the test standard and the scanning result. If a lower class of filter is installed, the filter class must be documented.	2
7.2.1.29	The serial number of HEPA-filter (H14)must be documented (for the sake of traceability).	2

7.2.2     Supply air diffuser

Requirement no.	Description	Code
7.2.2.1	Supply air must be brought in through ceiling diffusers. Exceptions are allowed if required by the process, to be approved by Nolato Medical Beijing.	2
7.2.2.2	All materials used must be described in data sheets and specifications enclosed to the documentation.	2
7.2.2.3	It must be possible to set up the supply air diffusers against the ceiling.	2
7.2.2.4	The inlet air apertures must withstand common cleaning agents e.g. 70 % Iso-propil-alkohol, Bendurol Forte, Molarsolv EV07, 70%-os etil-alkohol, GERMIMED, VANTROPOL, MEDONAL, INTOMILD. The chemical certificate conforming this must be enclosed to the documentation.	2
7.2.2.5	When placing the inlet air apertures in the room, consider the activity therein. The location of the process equipment, the ventilation installations and lighting must not inhibit the mixing of the air. The impetus and the range must be taken into consideration in order to have peaceful air movement in the room. Choose the location in consultation with NOLATO.	I
7.2.2.6	The supply air diffusers are positioned/distributed in the room as evenly as possible in order to avoid areas of stationary air. Positioning is documented in the drawings.	2

7.2.3       Exhaust air apertures

Requirement no.	Description	Code
7.2.3.1	Exhaust air must be led through apertures near the floor and in the roof above the injection moulds. Exceptions are allowed if required by the process approved by NOLATO.	2
7.2.3.2	All materials used must be described in data sheets and specifications enclosed to the documentation.	2
7.2.3.3	The extract air diffusers must be positioned /distributed in the room as evenly as possible in order to avoid areas of stationary air. Positioning is documented in the drawings.	2
7.2.3.4	Extract air diffusers in the room must be supplied with protecting grilles. The design must be approved by NOLATO.	2
7.2.3.5	The protecting grilles must be easily removed and reassembled.	2

7.2.4       Air apertures above

Requirement no.	Description	Code
7.2.4.1	NA

7.3        Pipe systems and other ventilation installations

Requirement no.	Description	Code
7.3.1	The ducting must be made of galvanized sheets.	2
7.3.2	All materials used must be described in data sheets and specifications enclosed to the documentation.	2
7.3.3	The duct system must be equipped with inspection holes The choice of location takes place in consultation with Nolato.	3
7.3.4	There must be sockets in the pipe system to control the air flow. There must be sockets so that it is possible to control the air flow in every room.	2
7.3.5	Bore all the holes and install all the sockets and sensors before installing a pipe section. No drilling can be made to the pipes after they have been sealed.	2
7.3.6	All pipes must be cleaned and sealed up before installation so as to ensure that there are no metal particles or dirt in the pipes before and after installation. Inspect the pipe sections visually with a view to cleanliness before the contractor installs them. Document the results and enclose to the documentation.	2
7.3.7	As the work proceeds, seal up the canals at the end of each work phase and at the end of the working day.	2
7.3.8	The intake section and the exhaust section must be positioned  such a way that exhaust air is not drawn into the intake section. The intake section must be positioned in such a way that possible external odours and sources of contamination like exhaust gases are not drawn in. Enclose a documentation explaining the choice of the location to the air management documentation. Take the effective main direction into consideration.	2

 

7.4        Air turnover

Requirement no.	Description	Code
7.4.1	There must be a process mode.	2
7.4.2	The air turnover measured in the incoming air must be ≥15 changes/h  for BEIJING MEDICAL FACTORY whole area	2

 

 

7.5        Differential pressure and air directions  

Info: The differential pressure must be constantly monitored through the Monitoring system.      

Requirement no.	Description	Code
7.5.1	The positive differential pressure from the BEIJING MEDICAL FACTORY to the unclassified halls must be ≥ 10 Pa under normal operating conditions.	2
7.5.2	The differential pressure must be measured and monitored over the sluice gates sides. The measurement points must be chosen in consultation with NOLATO. The differential pressure is presented on the layout, the pressure level and the air directions.	2
7.5.3	When setting the differential pressure, take eventual measuring errors in the calibration equipment and during inspection into consideration, and remember that the target value under normal operation should not be too close to the chosen alarm limit. The consequence of the target value being too close to the alarm limit is that fluctuations in the air management system and the opening of doors in the locks and rooms may result in false alarms .	2
7.5.4	The air must flow from ISO class 8 through the sluice towards the unclassified areas.	2
7.5.5	+10Pa  pressure diff.  from the unclassified part of the staff sluice gate towards the unclassified showing corridor. This is presented on the layout of the cleanliness category, pressure level and air directions.	2
7.5.6	The differential pressure meter must have a working range 0  to 50 Pa and a measuring uncertainty of ≤ 3 %.
7.5.7	The manufacturing certificate must be presented in the case of critically important sensors. (differential pressure)	2
7.5.8	The differential pressure must be monitored and logged, and exceeded alarm limits must be recorded in the Monitoring system as alarms.	2
7.5.9	The excess of alarm limits must be indicated visually in the production rooms. (red lamp)	2

7.6      Climate

Info: The temperature and relative humidity must be measured/monitored via the Monitoring (all temp and humidity condition equal in all cleanroom area)

Requirement no.	Description	Code
7.6.1	The temperature in all classified rooms must be 20 ±3 °C.	2
7.6.2	The relative humidity must have a target value of 55% RH with a permitted variation of ± 20 % RH. See the specification of every room.	2
7.6.3	The temperature and air humidity must be logged in the Monitoring system. Limit excesses must be recorded as alarm.	2
7.6.4	Temperature sensors Measuring range: 0 ... +40 °C or more Measuring precision: 0.5 °C or better	2
7.6.5	Relative humidity sensor Measuring range: 0-100% RH Measuring precision at 0...+ 50 °C  (0....100% RH) ±5. % RH at 20°C (40….60% RH) ±3. %	2
7.6.6	The manufacturing certificate must be presented for critical sensors (temperature and relative humidity).	2

7.7      Air adjustments

Requirement no.	Description	Code
7.7.1	The automatic adjustment takes place when the building is intact and the air management equipment has been put into operation and tested. The result have to be included in the documentation. The setting procedure must be documented and approved by NOLATO.	2
7.7.2	The fine-tuned adjustment must take place when all process equipment have been delivered, installed and put into operation . The result have to be included in the documentation	2
7.7.3	While the fine-tuned adjustment is taking place, no other activity which may disturb the adjustment is allowed in the building.	2
7.7.4	All instruments used must be calibrated and are traceable to national standards with the help of the attached copies of certificate of calibration of the measuring instruments. Current method of calibration must be documented and the documents must be attached.	2
7.7.5	Protocols of air adjustment must at least include information on partial flow of supply air, extract air, measurings of differential pressure and air flow directions, as well as calculated air changes figures, and the HEPA filters integrity investigation. Air change figures must be calculated on the bases of the final supply air flows and the measured room volume. The contractor provides a measuring protocol that must be reviewed and approved by Nolato before the measurement starts.	2
7.7.6	The protocol must be dated and signed by all performers.	2
7.7.7	The documentation must be approved by NOLATO.	2

 

7.8      Storage rooms for products and materials

Requirement no.	Description	Code
7.8.1	NA	2

 

7.9      Compressed air systems

Requirement no.	Description	Code
7.9. 1	6,5-8 bar pressure, dehumidified, oil free	2
7.9. 2	0.1 µm technical filter	2
7.9. 3	Dew point -40 to -60°C	3
7.9. 4	Material: fulfill the ISO 14644 requirement	2
7.9. 5	Pipe dimension diam min 50mm	3
7.9. 6	The pipes must be closed off with valve	3
7.9. 7	The alarm function must be logged in the Monitoring system	3

 

7.10   Central vacuum cleaner

Requirement no.	Description	Code
7.10.1	There must be a central vacuum cleaner or the possibility to install one at a later time.	2
7.10.2	All material in the cleanroom must fulfil the cleanroom requirements ISO14644 class 8	2
7.10.3	The unit must be placed outside the cleanroom	3
7.10.4	The placement of outlets according to the relevant drawing	2
7.10.5	Maximum number of simultaneous users is 1.	3
7.10.6	The central vacuum cleaner must have a fire alarm	3
7.10.7	Consideration shall be taken to the desing of the piping work so that it minimized pressure drops. Bends need to be smooth and of large radiuses.	3

7.11 Water/drain

Requirement no.	Description	Code
7.11.1	There must be water/sewage in the personnel sluice acc . the construction documentation. The quality of water must meet the requirements of the Chinese water standards .	2
7.11.2	The water to the injection moulding machine and to the heaters must be led in a closed system; the water must be deionized and decalcified.	3
7.11.3	Cooling water temperature tool circle 16,5°C  +/- 1,5 ,machine oil cooling circle 23°C +/-1,5	3
7.11.4	Wash basins tap valves must be controlled by photo cells or by other similar technique which makes hand- to- faucet contact unnecessary. Wash basins must be easy to clean.	2

7.12   Clean air system

Requirement no.	Description	Code
7.12.1	NA	2

7.13   Raw material management for injection moulding

See in the URS of the material supply system:
BEIJING MEDICAL FACTORY project_material_supply_system_and_auxiliary_equipment

8         CALIBRATION

Info: Applies to all control and alarm sensors/measurement points in the Monitoring system.

Requirement no.	Description	Code
8.1	The control and alarm sensors in the system must be designed so that it is easy to implement regular calibration.	I
8.2	Indicate in the document the sensors to be calibrated and present this to NOLATO.	2
8.3	The supplier should supply methods of calibration and calibration frequency for sensors.	2
8.4	The critical sensor must be calibrated at the time of delivery and calibration certificate must be attached. The calibration method used must be compatible with the national standard.	2
8.5	All reference instruments must be calibrated and compatible with the national standard. A copy of the calibration certificate must be enclosed to the documentation. The certificate must contain information on calibration points, date of calibration and the next date for calibration.	2
8.6	All critical sensors must be calibrated and the results must be presented in a calibration certificate or calibration report. The certificate/report must include information regarding the identification of the sensor (unique ID), the calibration method, the identification of the reference instrument, the calibration interval, the calibration points, the acceptance criteria, the results, the date of calibration, the next calibration date and the date and signature.	2
8.7	All applied software must be validated

 

9         REGULATORY REQUIREMENTS

Requirement no.	Description	Code
9.1	The delivered equipment must be in compliance with all EU legislation and regulations effective as of the date of the order.	3
9.2	The delivered equipment must be CE-marked.	3
9.3	The installation must be used to produce and install components of medical technical products and must meet the ISO 13485 standard.	I
9.4	The installation must meet the requirements of MSZ-EN-ISO 14644-1 to MSZ-EN-ISO 14644-8 for the number of particles and for the measurement methods. The recommendations concerning the design and operation of the installation must be taken into consideration.	I

 

10   REQUIREMENTS ENVIRONMENT AND SAFETY

Requirement no.	Description	Code
10.1	Noise levels ≤ 85 dB (A)	1
10.2	All warm surfaces should be clearly marked	1
10.3	Surfaces potentially causing injury by crushing or squeezing should be clearly marked	1

11   CHANGE CONTROL

Requirement no.	Description	Code
11.1	All changes should be investigated and decisions/approvals should be documented in e.g. memos and meeting minutes.	I
11.2	All changes in design must be documented in the relevant design document.	I
11.3	All design documentation must be updated in versions. Changes must be documented in the documentation history including at least the date of the change, its description, the responsible/implementing person.	I

 

12   REQUIREMENTS DOCUMENTATION

12.1   General proMonitorings

Requirement no.	Description	Code
12.1.1	Every document must have a unique ID and must be updated in versions.	I
12.1.2	References to other documentation must be clear, also featuring unique identifiers.	I
12.1.3	The instruction documents/manuals must be in Hungarian. Other documents can be in English or in Hungarian.	I
12.1.4	All documents must be signed and dated.	I
12.1.5	Raw data/results, dates and signatures must be written in archiving- resistant ink.	I
12.1.6	When changing a result or a text, cross the affected part with a line so that the result or the text can still be read. Provide the reason for the change in writing.	I

 

12.2   Documents from the project implementation/contractor

(in case of contradiction between the contract and the requirement specification, consult NOLATO about the way forward.)

Requirement no.	Description	Code
12.2.1	The project implementation/contractor must deliver the documentation according to the following: ·         Construction documents incl. technical documents and drawings ·         Relations documents (“as built” documents including the technical documents, drawings and sketches, D drawings) ·         Supplier quality project control programmes ·         Technical documents and data sheets for critical components ·         Functionality descriptions ·         Reports/documentation on adjustments, controls, tests and probes ·         Technical manuals for operation and maintenance of all input equipment/components ·         Manuals for all input software, including system software, applications and development tools for continued maintenance. ·         Validation report of all software applied ·         Instructions manuals for  use of the systems, equipment, etc. ·         Calibration certificates and methods ·         Parts lists and critical part list, preventive maintenance plans ·         IQ validation protocol & report	2
12.2.2	All test documents must be dated and signed by the contractor and signed and checked by NOLATO The contractor is responsible for the existence of signing and dating fields.	I
12.2.3	Test readyness control/coordinated testing Installation controls can be implemented when a system, e.g. the air management system or the cleanroom, is installed. Own controls must be implemented so as to verify that the system is ready for a coordinated test. a)    The project implementation /contractor must prepare the minutes for the own control and the coordinated test. The protocol for the own control or the coordinated test must define what tests should be implemented as per NOLATO’s requirements laid down in this specification. In case of a coordinated test check if the systems function according to the requirements laid down for their relevant environment. b)     The own control- and coordinated test protocol must be delivered to NOLATO five (2) weeks before the test at the latest. c)    The own control must be presented to NOLATO for review and eventual updating before the installation starts. d)    The project implementation/contractor must write a report about the own control and the coordinated test.	I
12.2.4	All design documentation must be approved by NOLATO.	I
12.2.5	All test documentation must be approved by NOLATO.	I
12.2.6	All documentation must be handled in a safe and controlled manner.	I
12.2.7	Documents that are part of the final documentation must be delivered in at least two copies. One original and one copy.	2

 

13     VALIDATION AND QUALIFICATION

Requirement no.	Description	Code
13.1	The premises must be qualified before production starts.	1
13.2	The IQ is responsibility of the contractor (IQ protocol and report approved by Nolato is a must to take over the premises) Implement a final review of the “Test readyness control/coordinated testing“ and have it approved by NOLATO before IQ starts.	1

 

14   REQUIREMENTS FOR MAINTENANCE AND SERVICE

Requirement no.	Description	Code
14.1	The contractor must draw up a list containing the parts of all input equipment/systems & spare part list and critical part list (Sub-supplier identification).	2
14.2	The supplier must prepare a maintenance- and service plan in colaboration with Nolato.	2

 

15   TRAINING

Requirement no.	Description	Code
15.1	The contractor must provide training courses for those members of Nolato’s staff who will be in charge of the equipment and the systems.	2
15.2	The contractor must supply proof of training courses provided for NOLATO’s staff after the courses are performed.	2
15.3	The contractor must be responsible for the costs of the training.	2
15.4	The contractor must provide course material for NOLATO’s future internal trainings.	2

 

16   REFERENCES

·         MSZ EN ISO-14644-1 “Clean rooms associated controlled environments Part 1- Classification of air cleanliness”
·         MSZ EN ISO-14644-2 “Clean rooms and associated controlled environments, Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1”
·         MSZ EN ISO-14644-3 “Clean rooms and associated controlled environments - Part 3: Test methods”
·         MSZ EN ISO-14644-4 “Clean rooms and associated controlled environments, Part 4: Design, construction and start-up”
·         MSZ EN ISO -14644-5 “Clean rooms and associated controlled environments, Part 5: Operations”
·         MSZ EN ISO-14644-6 ”Clean rooms and associated controlled environments, Part 6: Vocabulary”
·         MSZ EN ISO-14698-1” Clean rooms and associated controlled environment, Biocontamination control, Part 1: General principles and methods”
·         MSZ EN ISO-14698-2 ” Clean rooms and associated controlled environments, Biocontamination control, Part 2: Evaluation and interpretation of biocontamination data”
·         44/2005.X 10.19 EüM rendelet melléklete (GMP EUDRALEX, volume 4, annex 1.)
·         SS-EN 1822 Highly effective air filters (HEPA and ULPA)
·         AMA 98 General material and work description
 

17   ATTACHMENTS

Room functionality programme
Interlock plan

VERSION MANAGEMENT
 

Version	Date	Changed	Prepared by
1	2013.07.17	1st edition	Jonas Porat

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