USP797 has been a mandate that originated in the early 2000's. The need arose after illnesses and in some cases, death, were caused due to microbial contamination of compounded sterile preparations. The standards have gone through several changes since 2004 and will continue to evolve. The biggest challenge was noticed in the hospital sector. Prior to USP797, hospital compounding was practiced but not in a cleanroom environment. This left the hospital pharmacists in charge of building cleanroom environments to meet the USP797 mandate and ensuring the rooms met the regulations. Inspections were conducted by State Boards of Pharmacy and JACHO. This mandate will continue to make changes as challenges arise.
Why Cleanrooms Are Essential in Modern Manufacturing
Why Cleanrooms Are Essential in ModernManufacturing
Cleanrooms are no longer niche environments reserved for highly specialized industries. Today, they
are at the heart of manufacturing processes
Top 5 Cleanroom Compliance Challenges (and Howto Solve Them)
Top 5 Cleanroom Compliance Challenges (and How
to Solve Them)
The Future of Cleanroom Design: Trends to Watch in2025
The Future of Cleanroom Design: Trends to Watch in
2025
Who We Are & What We Do?
At Cleanetics, we design, build, certify, and maintain cleanrooms that meet the highest industry standards. Our team supports healthcare, pharmaceuticals, biotechnology, and advanced manufacturing by delivering safe, compliant, and reliable environments.
Why Cleanroom Maintenance Is Important
At Cleanetics, we understand that a cleanroom is more than just a controlled space—it’s the heart of critical work in healthcare, pharmaceuticals, research, and advanced manufacturing.
What are ISO 14644-1 and Federal Standard 209E?
Levels of ISO 14644-1 Standards. The acceptable amount of 0.5microns allowed in the ambient air.
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