This video is a step by step instruction on how to achieve negative pressure per USP <800>. Per the chapter, the containment secondary engineering control (C-SEC) must be externally vented and maintain a certain number of air changes per hour and a negative...
When designing a cleanroom for both USP <797> and USP <800> sterile compounding it might make sense to include an airlock between spaces in an effort to minimize or eliminate the ingress of particulates or CFUs. This principle is especially important if the...
There is a looming deadline on December 1, 2019 and that is the implementation of USP chapter <800>-Hazardous Drugs, Handling in Healthcare Settings. State Boards of Pharmacy (SBOP) are forming task forces and committees to determine if their state will fully...
USP chapters <797> and USP <800> use similar language with reference to surfaces inside of a cleanroom and hazardous drug compounding room, so when we consult with architects discussions around acceptable materials of construction are a strict focus. First let’s...
One of the areas that USP Chapter 800 Hazardous Drugs – Handling in Healthcare Settings does not directly address is the pre-sterilization process of a sterile preparation, hence the title of the article “Can a Class I and a Class II Biological Safety...
