
Immunology and Microbiology Cleanrooms
Large clinical-scale cleanroom operations for T cell therapies often use a class ISO 7 (Class 10,000) cleanroom room environment with an ISO 5 (Class 100) biological safety hood.
Large clinical-scale cleanroom operations for T cell therapies often use a class ISO 7 (Class 10,000) cleanroom room environment with an ISO 5 (Class 100) biological safety hood.
First published in 2004, USP Chapter <797> has undergone proposed revisions as of July 2018. These revisions are now available for public comment.
Updated: USP 800 is a cleanroom standard issued in March of 2014 by the United States Pharmacopeial Convention (USP). The deadline December 2019 for compliance may change.
USP Chapter 797 cleanroom design requires that facilities pressurize non-hazardous compounding and storage areas. ISO 5, 7 and 8 environments support primary engineering controls, buffer rooms, and ante-rooms.
Facilities unpacking hazardous drugs within a negative pressure room do not require procedural changes to meet USP unpacking area requirements. Facilities unpacking HDs within positive pressure ante rooms or facility spaces will require reconsideration.
A comparison of cleanroom classifications and specifications.
Cleanroom particle counters differ widely based upon particle threshold, cost, and features. How to do you determine if you need a particle counter or what model of particle counter to purchase? In this article we will go over the basics of particle counters and give you the facts to help you determine which one is best for your cleanroom application.