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USP 800 Impact to Engineering Controls

February 2016: Learn how USP <800> will impact primary and secondary engineering controls (e.g., biological safety cabinets, clean rooms, etc.). The webinar is intended to inform facilities that need to implement the new standards.

Isolator Performance Test

Baker Compounding Isolators and USP Requirements

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Explore Baker’s Pharmacy Isolator Products

Cazin JL, Gosselin P; Implementing a Multiple-isolator Unit for Centralized Preparation of Cytotoxic Drugs in a Cancer Center Pharmacy; Pharm World Sci 1999 Aug;21(4):177-83

Another case study, this article details the selection process of equipment for an area within the pharmacy for the preparation of cytotoxic drugs. In addition to explaining the reasons for use of barrier isolators, this article also underscores the importance of a safety and quality standards.

Tillet, L; Barrier Isolators as an Alternative to a Cleanroom; Am J Health Syst Pharm 1999 Jul 15;56(14):1433-6

This case study uses barrier isolators to insure sterility and containment in the preparation of cytotoxic and other hazardous agents. Relative to a cleanroom, the analysis found a reduction in costs attributable to reduced gown and glove use.

The 2012 USP <797> Compliance Survey: Measuring Progress

Report of a study done by Kate Douglass, Eric S. Kastango, MBA, RPh, and Peter Cantor that show current compliance with USP <797>. Published in Pharmacy Purchasing & Products in October 2012.

Wenzel R. Edmond M; The Impact of Hospital-Acquired Bloodstream Infections: Emerging Infectious Diseases, Vol. 7 No. 2, March-April 2001

This report assesses the scope and cost of bloodstream infections in the hospital, underscoring the importance of maintaining sterile conditions during preparation.

USP <797> Blog

A blog focused exclusively on USP <797> topics.

USP797.org

A full website developed to aid your understanding of the USP <797> regulation and its JCAHO-mandated schedule for implementation. Includes articles, consulting information, and a Q & A section.

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