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  • Essay / United States Pharmacopeia - 1072

    In 2004, the United States Pharmacopeia implemented strict rules and regulations to govern aseptic preparations (Johnston,12). These regulations cover areas such as: facility design, microbial contamination risk levels, personal training, clean room atmosphere, appropriate dress, and quality assurance (Johnston,12). Part of all this is preparing medications in germ-free conditions, especially if the medication in question is to be administered intravenously (Johnston, 12). USP 797 helps provide a safer environment for the production of sterile compounded medications to help save lives (Johnston, 12). USP Chapter <797> covers “Pharmaceutical Preparations – Sterile Preparations,” the purpose of which is to help prevent patient death. be treated with sterile products compounded against germinal contamination (“USP 797 standards and guidelines”). Anyone working with drugs that require a germ-free environment for compounding or preparation must comply with this chapter (“USP 797 Standards and Guidelines”). Guidelines focused on USP 797 include: compounding personnel responsibility, which covers responsibility for product preparation, as well as proper labeling, storage, and distribution (Johnston, 12); contamination risks, which divide products into categories based on contamination risks (Johnston,12); personnel training and evaluation, which provides the rules that personnel follow to produce a sterile product (Johnston, 12); Immediate Use of Sterile Compounded Products, which governs how compounded products should be handled in an emergency or simply needed immediately (Johnston, 12); single-dose and multi-dose containers, which compare single-dose and multi-dose containers, which include their expiration dates...... middle of paper ......n to cover clothing that may be contaminated and added to air contamination (Johnston, 20); and finally scrubs, the preferred clothing for working in a sterile preparation area (Johnston, 20). In conclusion, USP Chapter 797 provides guidelines on the proper procedures and standards that everyone working in a cleanroom must follow to prepare products in a sterile environment (Johnston,12). From the right way to wash your hands to how to keep contamination to a minimum, this overall makes the preparation of medical products safer for patients (Johnston,12).Works Cited1. 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 Laboratory Services. EMLab P&K. Internet. FEBRUARY 15, 2014.