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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…
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…
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…
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…
Before we delve into what stainless steel to use in your cleanroom and why, we want to give some basics about what stainless steel is which will help you better understand why the grade of stainless steel matters when choosing cleanroom equipment. What is Stainless Steel? Steel is iron combined with carbon. It is stronger…
Use of the laminar flow hood in your compounding pharmacy is a necessity to protect your products and the patients that use them. We offer tips on its use including how we can help you procure all the right cleaning products and PPE apparel needed to property use the hood. The enclosed workstation creates a…
USP 797 has been implemented by compounding pharmacies, hospital labs, and other healthcare facilities for almost 20 years now. But maintaining sterility is still a common source of confusion, and as humans are the biggest source of contamination in a cleanroom, it is generally a process that must be vigilantly monitored, evaluated, and improved. But…
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,…
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…
The Importance Of Proper Cleanroom Mop Use Now that your clean room is up and running, you may think the hard part is done. Maintaining the cleanliness of your cleanroom is an everyday project that is vital for success. Albeit that your facility is now ready for workers to work and products to be made,…