Ask the Experts at Cutsom-Cal: visit www.Custom-Cal.com or call (908) 328-3663 about certification of your clean room. Certifications are performed by engineers and metrologists with extensive OEM and PMEL experience. We have the expertise and the necessary standards to certify or validate your clean room. Clean room certification is vital to countless manufacturing processes in the industrial world. Whether you require certification for biotechnology, pharmaceutical, microelectronics, medical, military or telecommunications, the following are examples of qualifications the experts at Custom Cal can help you meet:
? 21 CFR 1271 for Human Cell, Tissue, and Cellular and Tissue-Based Products (HCT/P)
? 21 CFR Part 11 Compliance
? GMP and cGMP Particle Counting Requirements for EU and FDA Regulations
? ISO 14644 Cleanroom Classification
? ISO 21501: Determination of Particle Size Distribution
? ISO Cleanroom Class Particle Monitoring
? Microbial
? Monitoring Particles in Injectables for USP 788 and EP6
? USP 797 Particle Monitoring Solutions