Clean room ceiling

Filter Location HEPA filters may be installed in a facility either within an air handler or at the inlet to a plenum above the clean room or in the clean room ceiling. High-velocity HEPA filters, that is, filters with a face velocity up to 500ft/min, are frequently installed in air handlers serving Class 100,000 clean rooms and are also used in make-up air handlers. Where hazardous materials may be trapped by the filters a bag-in-bag-out filter arrangement, such as that depicted in Figure 16, may... 

Figure 9.29 shows a typical arrangement of a laminar-flow clean room. The flow may be vertical through a perforated ceiling and floor. 

In some installations (e.g. clean rooms), the electrical distribution system can be located in the sealed ceilings, allowing maintenance access without affecting the clean facilities (Figure 7.12). 

Figure 3.1. Diagrammatic illustration of the flow pattern of HEPA-filtered air through a t5 pical clean room. Air is pumped into the room through HEPA filters (see text) located in the ceiling, and exits via extract units, normally located at floor level. Although the air flow is non-unidirectional (i.e. not true laminar flow), it generates a constant downward sweeping motion, which helps remove air-borne particulate matter from the room...

To determine if there is intrusion of unfiltered air into the clean work areas from outside the clean room enclosure through joints and cracks in the walls, ceiling, etc., other than from the pressurized air supply system... 

Lighting. Lighting hxtures in the manufacturing areas are dust- and airproof surfaces, flush-mounted, clean room types. They are sealed to the ceiling with pharmaceutical-grade silicone, serviced from above, outside the manufacturing area. 

HEPA hlters are installed at the upper face of the pressure plenum and the plenum is pressurized with hltered air. The ceiling-mounted HEPA hlters have a face velocity up to 100-120ft/min. This is somewhat higher than the HEPA hlters serving the rest of the clean room. The hlters are commonly supplied with air by a... 

When bringing the utilities to the point of use, care should be taken to ensure that the clean room is not compromised. A clean construction protocol should be implemented and wall, ceiling, and floor penetrations, if needed, should be flashed and sealed in such a manner as to prevent contaminants from entering the clean room. Such entry points should also be smoothly sealed to ensure that there are no crevices to harbor organisms. Drains should be avoided in the clean room wherever possible. When this is not possible, the drains should be covered when not in use with a means specifically designed for biopharmaceutical clean-room application. Such means are tight, smooth, cleanable, and corrosion resistant. 

Standard construction techniques are used until the clean-room envelope is completed, HEPA filters with protective film in place are installed and air handlers are ready to start. The clean envelope consists of clean-room walls, ceiling, and floor. Prior to starting the air handlers, a thorough clean-up of the space within the clean envelope is accomplished as described in Appendix B, 2A-2J. Following clean-up and start-up of the clean-space air-handling system, particle counts should quickly drop to well within operational requirements. 

This is used for construction of those areas rated at Class 100 (ISO 5) employing a 100% HEPA filter ceiling. Generally standard construction techniques should be used. The clean-room envelope includes walls, ceiling, floor, return ductwork, supply fans, and supply ductwork. 

For making sandwich panels both the resol-type and benzylic ether-type foams can be used. These sandwich panels are used as building materials (partition panels, ceiling panels, wall panels, panels for clean rooms, door panels, panels for prefabricated refrigeration storehouses, etc.). 

In general, the CL is operated as a mixed-flow clean-room facility, meaning that the Class-lOO/ISO Class 5 areas are the workbenches and fiime cupboards in the various rooms, rather than the entire room. A laminar flow of clean air falls from high-performance particulate (HEPA) filters in the suspended ceiling of the room and is directed to the work area by plastic curtains. Certain clean laboratories in the network employ full laminar flow in the rooms at US Class lO/ISO Class 4 cleanliness conditions. The most sensitive measure of effectiveness is the blank levels of U and Pu that can be achieved, rather than the chosen cleanliness class. Blanks consist of the following types ... 

What should be attended to in the assessment of the DS In premises intended for sterile and aseptic preparations (clean rooms) the most severe requirements apply to the walls, doors, floors, ceilings, heating and furniture, see further subsections. Premises which are only intended for non-sterile preparations can do with less far-reaching demands. Nevertheless in practice it might be wise to apply the requirements for sterile premises also for non-sterile premises if both are at stake. In the first place in a new building the itemisation of methods and materials between premises meant for sterile preparation and for non-sterile preparation usually doesn t yield much cost reduction. Additionally many of the starting points for the requirements for sterile preparations more or less apply to non-sterile . 

Mobile dust removers (vacuum cleaners) with integrated HEPA filter are used in clean rooms, most of the time to clean the floor and ceilings. Dust removers are not designed to extract fumes, because fumes pass the filter unit and are blown back in the room. The HEPA filter has to be replaced periodically. 

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