Usp 800 Cleanroom Design

The usp compounding expert committee is responsible for the development of general chapter 800.

Usp 800 cleanroom design.

Whisperflow laminar flow hood meets iso 5 primary engineering control requirement of usp 797. Usp 800 allows this but only for drugs that will be used for sterile compounding. The current design of common commercial hvac systems are mostly inadequate for maintaining usp 800 s required acph engineering and iso clean air standards. Because compounding pharmacists handle hazardous drugs in usp 800 labs the room is designed to contain and remove chemical contamination.

Usp 800 is a regulatory chapter issued by the united state pharmacopoeia. Cleanroom suite with usp 795 usp 797 usp 800 compounding areas. Pac s usp 797 and 800 cleanrooms provide cross functional structures with parallel rooms that share entrances and gowning spaces. Parallel designs provide the proper ante room requirements via cascading air systems.

Purifier logic biosafety cabinet is ideal for hazardous drug containment per usp 800 regulations usp 797 800 cleanrooms. To contain harsh drugs and contaminants in the lab the usp 800 door swings into the room. Additionally a common commercial hvac system usually only achieves 4 to 6 acph. It covers crucial standards and design requirements for the safe handling of hazardous drugs in pharmaceutical and healthcare environments.

Usp 800 context for implementation published 11 26 2019 compendial applicability of usp 800 published 11 18 2019 usp 800. By transporting non sterile hazardous drugs through sterile spaces the pharmacy increases the risk of cross contamination. 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. This fails to consider the non sterile hazardous drugs which will need to be stored in a separate negative pressure storage room.

Click here to see our state of the art usp 797 and usp 800 compliant cleanrooms click here to see our usp 797 and or usp 800 compliant mobile relocatable modular. Mecart is a north american turnkey design build cleanroom manufacturer with over 45 years of experience building world class cleanrooms. General chapter 800 was published on february 1 2016.