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.
A Fresh Start for 2026: Why Now Is the Time to Upgrade Your Cleanroom Strategy
As we step into a new year, many organizations are setting goals for growth, efficiency, and innovation.
For companies in biotech, pharmaceutical manufacturing, medical device production, advanced
materials, and high-precision industries, a cleanroom isn’t just a part of the facility—it's the heart of
operations. And the new year is the perfect time to ensure that heart is performing at its best.
At Cleanetics, we believe that a cleanroom should evolve with the demands of your industry. Whether
you need an upgrade, a full-build custom solution, or an evaluation of your current environment, the
start of the year is the ideal moment to invest in a cleaner, safer, more compliant future.
How Proper Cleanroom Maintenance Saves Time and Money
Cleanrooms represent a significant investment, but without proper maintenance, they can quickly become liabilities. Preventive care is essential to protecting both financial and operational resources. **Reduced Downtime**: Malfunctioning systems can...
Turnkey Cleanroom Construction: What It Means and Why It Matters
Building a cleanroom is a complex project that involves design, engineering, construction, and compliance. A turnkey solution simplifies the process by providing a single point of accountability. With turnkey construction, Cleanetics manages every...
Why Cleanrooms Are Essential in Modern Manufacturing
Why Cleanrooms Are Essential in Modern Manufacturing
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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