USP797 Products

Cleanroom Filters & Supplies can help you with all your USP797 needs from
single components to complete systems.

Cleanrooms - A minimum of ISO Class 7 particulate levels using airflow dilution, temperature and humidity control within the buffer room.  Walls, floor and ceiling should be smooth, impervious, free from cracks or crevices, non-shedding and resistant to disinfectants. 

Cleanroom (buffer area) should attain ISO Class 7 Cleanliness Levels.  Cleanroom (buffer area) should be so designed as to provide positive pressure thereby preventing particle ingress into the clean areas. Cleanroom (buffer area) should not contain sinks or floor drains. 

Ante Room (clean area for donning personnel barriers and help minimize ingress of particulates into buffer room) should have a “hands-free” operating sink, air hand dryer, coat hooks and uniform storage.  Supplies such as needles, syringes, ampoules, bags, vials of parenteral fluids and packages of transfer tubing sets for large volume fluids must be un-cartoned and disinfected.

Gowning will include hair/beard covers, gloves, knee-length gowns/coats or full cleanroom attire, shoe covers, and appropriate PPE.  A facemask is optional when using a barrier isolator or vertical LFCB with a permanent shield between operator and sterile material, but head and facial hair must be covered.  All hand and arm jewelry must be removed prior to gowning.

Cleanroom construction:

Ceiling tiles should be impregnated with a polymer to render them impervious and hydrophobic.  Ceiling tiles sealed with RTV to the support frame.

Lighting fixture exterior lens surface should be smooth, mounted flush and sealed.

Filtration should be of sufficient air changes to maintain Cleanliness Classification during all modes of operation.  A rule of thumb would be to discount the use of LFCB and BSC discharge air.

Walls may be panel-locked and sealed or of epoxy-coated gypsum board.  Junctures to ceilings and walls should be coved or caulked to avoid cracks and crevices where dirt can accumulate. 

Floors are overlaid with wide sheet vinyl flooring with heat-welded seams and coving to the sidewall.

USP797 Compliant Products

Cleanroom Garments	Cleanroom Shoe Cleaners	Tacky Mats
Wipes	Cleanroom Furniture	Storage Containers
	Stainless Steel Pass-Thru's

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