Usp 800 Cleanroom Design

This fails to consider the non sterile hazardous drugs which will need to be stored in a separate negative pressure storage room.

Usp 800 cleanroom design. To contain harsh drugs and contaminants in the lab the usp 800 door swings into the room. Pac s usp 797 and 800 cleanrooms provide cross functional structures with parallel rooms that share entrances and gowning spaces. Because compounding pharmacists handle hazardous drugs in usp 800 labs the room is designed to contain and remove chemical contamination. Parallel designs provide the proper ante room requirements via cascading air systems.

Usp 800 allows this but only for drugs that will be used for sterile compounding. General chapter 800 was published on february 1 2016. Cleanroom suite with usp 795 usp 797 usp 800 compounding areas. Usp 800 is a regulatory chapter issued by the united state pharmacopoeia.

When you work with cleanroom design llc you are guaranteed the most state of the art technology and the highest quality of specialized engineering for your cleanroom project. Review their work plan and past meeting summaries. It covers crucial standards and design requirements for the safe handling of hazardous drugs in pharmaceutical and healthcare environments. The current design of common commercial hvac systems are mostly inadequate for maintaining usp 800 s required acph engineering and iso clean air standards.

Purifier logic biosafety cabinet is ideal for hazardous drug containment per usp 800 regulations usp 797 800 cleanrooms. Whisperflow laminar flow hood meets iso 5 primary engineering control requirement of usp 797. Mecart is a north american turnkey design build cleanroom manufacturer with over 45 years of experience building world class cleanrooms. Additionally a common commercial hvac system usually only achieves 4 to 6 acph.

By transporting non sterile hazardous drugs through sterile spaces the pharmacy increases the risk of cross contamination. Usp 800 context for implementation published 11 26 2019 compendial applicability of usp 800 published 11 18 2019 usp 800. Usp 800 clean room usp 800 hazardous drugs clean room design and construction by descco the united states pharmacopeial convention usp chapter 800 provides standards for handling hazardous drugs to promote patient safety worker safety and environmental protection.