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Cleanroom bags are used to package sensitive products that cannot be exposed to particles or contamination. Clean room bags are made inside of a clean room to ensure they are contamination-free since they are housing delicate items. This means no foreign substances in or on the cleanroom supplies and no release of chemicals and other…
As with cleanroom contamination, the source of failure in airlocks or anterooms is human behavior. Bioburden is the number of bacteria living on a non-sterilized surface and is the primary source of cleanroom contamination. There are many methods and processes involved in controlling microbes in a cleanroom, including the use of an anteroom, airlock, or…
Using cleanroom wipes for disinfection is common in compounding pharmacies, laboratories, hospitals, medical device manufacturing, food handling, and other sterile processing industries. In addition to using the proper lint-free wipe, you should choose the right method to apply the solution and the optimal wiping method for your disinfection application. The right cleanroom wipe for your…
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…
The pharmaceutical compounding process of customizing and blending drugs to meet needs specific to a patient is not a new service. In fact, people have been compounding drugs for millennia. Most of that time the physician has been both the prescriber and the compounding pharmacist. Earliest Pharmaceutical Compounding History It is impossible to say when…
Using shoe covers in a way that complies with USP800 is a small, but vital, detail in controlling microbial contamination in your critical environment. Proper use of shoe covers also protects cleanroom workers and others outside the cleanroom when hazardous drugs (HDs) are handled. USP800 specifically addresses the use of shoe covers. This includes a…
Cleanroom microfiber wiper products have been around for a while, but most people do not realize just how revolutionary and useful this technology is. As with household cleaning, many people still do it the way they always have. And, while it may follow “standard operating procedure”, the benefits of cleanroom microfiber wipes are worth a…
Selecting cleanroom wipes to use in your controlled environment is one of the most important decisions made for controlling contamination. They are vital in not only removing contamination, but also, in preventing it. Stricter cleanrooms must utilize low-linting or lint-free wipes. Per USP <797> “Pharmaceutical Compounding: Sterile Preparations” 2008, US Pharmacopoeia, Rockville, MD Table 3,…
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…
Each application within a typical cleanroom, a healthcare facility, or industrial process is unique and has varying requirements for personal protective equipment (PPE) including specialized apparel. Sometimes the job of the apparel is not only to protect the worker, but also to protect the environment and sometimes products created by an application from contamination. Below…