USP 797 Guidelines
Cleanrooms are a contained area where a laminar flow of HEPA or ULPA filter air is fed to provide a pre-determined level of cleanliness. That level is the number of .5 micron or larger particles
in a cubic foot of air. In the case of USP 797, the level is ISO Class 8 (formerly Class 100,000). An ante area, or gowning area, is required and may or may not be separated by a physical wall depending on the risk level. Cleanrooms may be hard wall or soft wall, free standing or converted rooms or parts of rooms.
ISO CLASS 7 & 8 SOFT WALL CLEANROOMS
Soft wall cleanrooms are the most common rooms especially in ISO Class 7 and 8 (Class 10,000 and 100,000). They may be free standing or incorporated into a portion of an existing room. Free standing soft wall cleanrooms are relatively inexpensive, easily assembled by in-house personnel and readily moveable and expandable. The cleanroom is placed on a seam and crack free floor, usually vinyl with welded seams. Most of our soft wall cleanrooms may be assembled by one, but preferably two competent maintenance personnel in a day or two. When pre-wired, the only additional item is to have a single connection wired into a junction box by a certified electrician. All the pieces are pre-drilled and easily assembled. Construction time and debris are minimal (see CAP 577).
CLEANROOM STRUCTURES WITH WALLS
An alternative to a free standing unit is to use one or more existing walls as a part of the cleanroom structure. A curtain may be used to divide a room or multiple curtains may be used to cordon off a corner or section of a larger area. Again, the floor must be seam and crack free (generally a vinyl floor with welded seams) and in this case, the walls painted with an epoxy cleanroom wall paint to resist the introduction of particles. Curtains are used to divide the area from the rest of the room. Motorized HEPA filters, cleanroom lights and cleanroom ceiling tiles are suspended in a ceiling grid, normally 2 x 4 foot. This is similar to most 2 x 4 grids but because of the weight of the motorized filter and tiles, this gridwork should be heavy duty. A strip door is normally added for entry. Portions of a free-standing unit may also be used to construct one, two or three walls of the structure. Our NCI staff is available to assist you with the planning of your cleanroom project. See below for some of the items that may be required.
Additional Cleanroom Items
MOTORIZED HEPA CEILING FILTER (12BL-424)
ENVIROGARD CEILING TILE (WI-1190CRF1)
LIGHTS (1210142120)
PAINT (CX5200-1)
CEILING GASKETING (gasket)
HARD WALL CLEANROOMS
Hard wall cleanrooms are similar to soft wall cleanrooms in that they are easily assembled, expandable and moveable. There a several reasons to select a hard wall cleanroom over a soft wall. The first is its aesthetic appeal. The hardwall cleanroom also allows for double wall construct to provide less costly heating and cooling, especially in larger cleanrooms. Cleaning may be easier and the hard walls may provide less chance of contamination in high traffic areas. Using one or more of the hard walls can also be used to convert an existing room into a cleanroom. (see CAP 591)
CONVERTING AN EXISTING CLEANROOM
An existing room may be converted into a clearoom with some minor modifications. First, the room must be properly vented. The vents provide the HEPA filtered air a place to escape and must be placed so as not to create "dead spots" where the air stagnates and becomes contaminated with particles. Many times the venting is accomplished with a double wall or plenum. Preparation of the walls and floors is required. Addition of cleanroom lights, tiles and mortorized HEPA filters is necessary. The door can be replaced with strip curtains or a cleanroom door and an ante room or gowning area can be added inside or outside the room. NCI knowledgeable staff can help you with this convesion process.
Please Contact Innotech for Information that fits your Cleanroom Specifications!
