Cleanroom Classification

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.

Read More »

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.

Read More »

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.

Read More »
cleanroom particle counter in use

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.

Read More »
Sign Up to Our Newsletter

Categories
Search Posts
PAC on Twitter
Follow me on Twitter