USP <797> Revisions Take Effect November 2023

After years of collecting and analyzing information across the industry, the United States Pharmacopeia (USP) published its final version of the revisions to General Chapter <797> Pharmaceutical Compounding – Sterile Preparations, originally issued in 2008. The USP update to <797> incorporate advances in science and clinical practice and aim to clarify topics that were not…

USP <797> Compliance Overview

Our website offers useful information for getting and staying USP <797> compliant. See USP <797> revisions for November 2023. This guide serves as an overview to these resources. Our trained cleanroom consultants can assist you with questions about your specific protocols especially if you are facing issues with contamination or product incompatibility. Just ask! USP…

Donning and Doffing Cleanroom Apparel Effectively

Proper Cleanroom Attire Correct cleanroom attire for your application is vital, but not effective if not donned and doffed correctly. Specific gowning procedures within your overall cleanroom SOPs often differ between critical environments, the basic steps apply to all. Proper donning and doffing of cleanroom garments prevents contamination of manufactured products and the worker. But…

Sterilizing with Hydrogen Peroxide in Cleanrooms

Hydrogen peroxide is an excellent sterilizing solution to include in your cleanroom’s standard operating procedures for cleaning. Sterile controlled environments must rigidly adhere to cleaning and disinfecting regimens and most include hydrogen peroxide. Hydrogen peroxide disinfection is effective against a wide variety of micro-organisms and is cost-effective, it is a safe alternative to other methods…

Microbial Contamination Control in a Cleanroom Environment

Feature image: E. coli Bacteria (CC BY 2.0) by NIAID Preventing, detecting, and eliminating cleanroom contamination from bacteria, viruses, and spores is an ongoing battle. But a battle that must be fought consistently and methodically in controlled environments for pharmacies, hospital labs, biomedical manufacturing, and other health-related controlled environments. People’s health, and perhaps lives, are at stake. Proper,…

Pharmacy Cleanroom Cleaning to USP Standards

Compounding Pharmacy Cleaning to USP Standards with Troubleshooting Ideas The video from Pharmacy Purchasing & Products below is chock full of information about how USP 795, 797, and 800 guide cleaning protocols and creation of related standard operating procedures (SOPs) for non-sterile areas and sterile pharmacies. It offers specific guidance about keeping your critical environment…