The regulations and standards that need to be met vary with the applications and industry your company is involved in. A cleanroom used for sterile compounding of hazardous drugs is completely different from a cleanroom for pharmaceuticals or microelectronics. Depending on your industry and application, you might have to comply with an ISO 5 to 8 class standard, the FDA and ISO-14644 regulations. In pharmaceutics, you will certainly have to comply with GMP. For sterile compounding, NAPRA and USP 797/USP 800 will apply. We must make sure your design complies with the given regulations to get your certification and validation.
