Every effort is made to keep the website up and running smoothly. However, CLIN® takes no responsibility for, and will not be liable for, the website being temporarily unavailable due to technical issues beyond our control.
ISPE Baseline Sterile Manufacturing Facilities
An area with defined environmental control of particulate and microbial contamination constructed and used in such a way as to reduce the introduction, generation and retention of contaminants within the area.
PIC/s PE 009-6
Strict procedures are must followed to prevent contamination to the product by controlling the total environment. Air flow rates and air flow direction, pressurization, temperature, humidity, non-viable airborne particle and viable particle counter to be complies with regulatory.
On the upstream levels, design of the Cleanroom as the main criteria should be in place prior goes to the downstream and processes.
Construction and Design of Cleanroom are generally defined as follows:
1. The materials of construction of a clean room should be smooth on the surface facing the inside of the clean room. Color selection for ceiling, walls and doors is white. Nowadays commonly used sandwich panel filled with Polyurethane or polystyrene complete with steel plate coated baked finishes.
2.The surface should be free of ledges and easily wiped free of any contamination that is deposited. The surface finish in a clean room must not break up easily and disperse chips or particles of material which may contaminate the cleanroom.
3. The butts and joints, as seen from the inside of the clean room, should not show openings that may harbor, and then disperse, dirt. Penetration point (e.g. for utility services, sprinklers or other devices and light fixtures) should be kept to the minimum required, and be sealed with proper silicon type (eg. anti-fungal, FDA approved)
4. Utility services supplied to process equipment are piped in with piping and cables hidden (eg. in raceways with coated steel plate panels complete with proper label such as direction flow and tagging).
5. Wall, floor and ceilings in clean rooms should be designed and constructed in such a way that the surfaces are accessible for cleaning.
6. Clean room surface, especially floor, should be able to withstand chemical disinfectant that used in clean room or liquid products. Some processes use strong acids or solvents that will attack surface.
7. Flooring type for clean room shall be easy cleanable, chemical resistance; corner and junction may provide flush coving especially at floor-to-wall and wall-to-wall junction for floor to wall to ceiling.
8. Ceiling system shall be not obstructing personnel from inspection or provision for other services
9. Pass through boxes both active and standard, should double interlocks with indicator lights.
10. Air diffusers in the corridors and processes rooms should be design in such a way to prevent dust contamination.
11. Air showers for dedicated areas with sensitizing drug substances. Only placed at exits from processing zones.
12. Restricted access to authorized Production, Engineering staff by means of Proximity Card Readers and magnetically locked doors. These devices are placed at the entrance to the clean room production area
13. Fire sprinklers, recessed type designed for cleanrooms and dome type smoke detectors. Fire extinguishers (powder type), boxed in, flush and sealed. Should be access easily and visible during emergency.
14. Consideration should be given to the location and configuration of components such as lights and sprinklers, detectors to avoid disturbance of the intended airflow.
15. Ceiling should be sealed, to prevent ingress of air borne particles, or other contaminants, from the ceiling void/technical space.
1. Floor surface layers should be non-porous, slip-resistant, abrasion-resistant, conductivity if necessary; resistant to the chemical and easy to clean.
2. The self leveling epoxy flooring typically with 3.5 mm thick self leveling epoxy with excellent mechanical and chemical resistance and covering with flush coving from wall to floor.
3. The floor should support heavy static and dynamic loads with the required durability.
1. Wall system shall be flush structure, made of panel material is coated steel or stainless steel with flush coving. Safety glass window can be integrated flush in a panel.
2. Cover strips or seals between panels should be smooth, with flush fitting to facilitate efficient cleaning and limit retention of contaminant.
3. Where glazing in wall or door, it should be of the non-opening type. If binds or shutters are required, these should be fitted outside the clean zone. Glazing frame should be smooth.
1. Door handles, lever type, where required, should be smooth, non-staging and easy to clean. Doors are single or double leaf swing, half glass type with door closer and lock set. Doors shall be reasonably air sealed tight with a self-rising/gravity-fall bottom flap to prevent air leakage.
2. Doors complete with Retractable Bottom Flap Seal, single glazed flush.
3. Doors complete with automatic closer/ door closer.
1. The lighting levels and uniformities design is required to provide good architecturally room lighting and the lighting position above ceiling. Certain level of lux to be defining for sufficient luminaires during manufacturing/ processes.
2. The color rendering of light should be specified and should provide significant effect on the comfort of personnel and manufacturing process.
3. The lighting system design should be consistent with the effective of the clean room. Light fitting should free of contamination may be released. Commonly the cleanroom lighting comes with dense gasket (neoprene) for airtight closure.
4. The used of sealed of flush fitting should be selected. This type of lighting may come with top access (maintenance will be external cleanroom which will not interrupt the process or cleanroom integrity remains).
5. For unidirectional airflow area or room, the design and positioning of light fitting and associated diffuser should be such as to minimize or negate turbulence. Tear drop type commonly use for the Unidirectional flow areas (Grade-A Clean room classification).
6. The lighting should be serviceable in a manner such that the integrity of the clean room in not violated and excessive contamination is not produced.
7. The effect of glare should be considered within the context of the work being carried out.