2018 USP Sterile Compounding Revisions
First published in 2004, USP Chapter <797> has undergone proposed revisions as of July 2018. These revisions are now available for public comment.
Cleanroom Classification
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USP <800> Compounding Cleanrooms
USP 800 is a cleanroom standard issued in March of 2014 by the United States Pharmacopeial Convention (USP). The deadline for compliance may change, at the time of this articles publication the deadline is scheduled for December 2019. The date and scope of adoption may differ on a state-by-state basis, thus consulting with a compliance specialist is encouraged.
USP 797 Guidelines: Sterile Compounding Cleanroom Design, Components, and Procedure
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.
How Does USP 800 Change Storage and Unpacking of Hazardous Drugs?
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.
Cleanroom Classification Comparison Specifications Defined
A comparison of cleanroom classifications and specifications.
How to Choose the Right Cleanroom Particle Counter
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.
