In 2004, the United States Pharmacopeia put into place strict rules and regulations to govern aseptic preparation (Johnston,12). These regulations cover areas like: facility design, microbial contamination risk levels, personal training, atmosphere of the clean room, proper dress, and quality assurance (Johnston,12). A part of all this is to prepare the medications in germ free conditions, especially if the medication in question is going to be given intravenously (Johnston,12). USP 797 helps provide a safer environment for the production of sterile compounded medication to help save lives (Johnston,12).
The USP chapter <797> entails “Pharmaceutical Compounding – Sterile Preparations”, the intent of this is to help prevent death to patients being treated with compounded sterile products from germ contamination (“USP 797 standards and Guidelines”). Anyone who works with medications that require a germ free environment to be compounded or prepared needs to comply with this chapter (“USP 797 standards and Guidelines”) . Guidelines focused on in USP 797 include: responsibility of compounding personnel, which covers the responsibility in compounding products, as well as labeling, storing and dispensing properly(Johnston,12); contamination risks, which divides products into categories based on the risks of contamination (Johnston,12); personnel training and evaluation, that gives rules that personnel follow to make a sterile product (Johnston,12); Immediate use of compounded sterile products, that governs how to handle products compounded in the event of an emergency or simply needed immediately (Johnston,12); single and multi dose containers, that compares single dose containers and multi-dose, which includes their dates of expi...
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...n to cover clothing that may be contaminated and add to the air contamination (Johnston,20); and finally scrubs, the preferred clothing for work in an sterile compounding area (Johnston,20).
In conclusion, USP chapter 797 help provide guidelines for the proper procedures and standards that all who work in a clean room must comply with to compound products in a sterile environment (Johnston,12). From the proper way to wash your hands to how to keep contamination to a minimum, it overall makes the preparation of medical products safer for patients (Johnston,12).
Works Cited
1. Johnston, Mike. Sterile Products and Aseptic Techniques for the Pharmacy Technician. 2nd edition. New Jersey: Alexander, 2010. print.
2. USP 797 Standards and Guidelines with USP 797 Testing Lab Services. EMLab P&K. Web. February 15, 2014.
Comment on class result with respect to differences in filter types, differences in filter assemblies, and overall on the confidence you would have in using this type of sterilisation process in preparation of pharmaceutical products. List the factors that may cause contamination during filtration. (20 marks)
Decontamination packing and sterilization of surgical instrumentation. 2. Prosing and reposing of procedures reusable medical devices. 3. Cleaning testing assembly, and distribution of movable patient care equipment.
Yacopetti, N., Davidson, P., Blacka, J., & Spencer, T. (2013). Preventing contamination at the time of central venous catheter insertion: a literature review and recommendations for clinical practice. Journal Of Clinical Nursing, 22(5/6), 611-620. doi:10.1111/j.1365-2702.2012.04340.x
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