GMP, Cleanroom and Server Room Cleaning

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cGMP (Current Good Manufacturing Practices) contain both requirements and guidelines for manufacturing of food and drug products in a sanitary environment. The Food and Drug Administration FDA CFR Title 21 mandates that any building used to manufacture a drug, food, medical device, cosmetics or holding of such shall be maintained in a clean and sanitized condition.

Disinfection is the process of sanitization eliminating many or all bio-burden, including viruses, bacteria, molds and yeasts, except bacteria spores, on inanimate objects. Disinfection is achieved by liquid disinfectants.

A sporicide is required for effective elimination of spore-forming microorganisms. this process is usually performed during the initial validation cleaning methods and periodically thereafter, based on the validation outcome and documented SOPs.

Cleanroom Cleaning

Cleanroom cleaning methodology is the same as GMP cleaning above except a cleanroom detergent  or DI water / Isopropyl blend products are used instead of disinfectants. The cleaning process remains cleaning from the area in the room farthest from the exit, cleaning top-down, side to side to remove particulates. Cleanroom cleaning may also have added steps prior to the liquid cleaning phase such as vacuuming with HEPA filtered Nilfisk vacuums or using cloths to remove particles at 0.25 microns and larger. This step increases the effectiveness of the cleanroom cleaning.

This cleaning process can also carry over to USP 797 compounding Pharmacies.