Cleanroom Environmental Monitoring Standards are set by the FDA/USP/EU/cGMP. The parameters that need to be adhered to are determined by your industry. For example, the USP797 and USP795 regulations will be for hospital pharmacies/503A/B sites. Medical Device Companies adhere to a different regulation. Our team will first determine your industry and will know the regulations you must comply to.
Our team of Certifiers stay up to date on changing guidelines and will follow ISO14644-1 Standards. Our Cleanroom Certifications services include: HEPA filtration testing, particle counts (viable and non-viable options), pressure differential, temperature & relative humidity, BSC/LAFW/PEC certifications and decontamination. Completed Certificates are issued within 5 days of completed services.