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Basics of Compounding: Certification of Sterile Equipment and Facilities: What Pharmacists Need to Know

Author(s):  Lanze Amanda, Rudner Shara

Issue:  Sep/Oct 2014 - Volume 18, Number 5
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Abstract:  Although it is common knowledge that all sterile compounding pharmacies must have their equipment and facilities certified and calibrated every six months, it is not as clear what is expected of pharmacists. There is currently a disconnect between the certification companies and the pharmacists. As pharmacists, we look to the certification companies as the experts and rely upon them accordingly. The certification companies look upon the pharmacy to know which testing is required. It is the role of the pharmacist to know which tests are necessary and how they are to be interpreted correctly. The end goal of certification testing is to prove that the standards listed in United States Pharmacopeia Chapter <797> are met. Testing requirements can vary from state to state. A few of the most commonly required sterile certification and calibration tests will be discussed in this article.

Related Keywords: Amanda Lanze, PharmD, Shara Rudner, RPh, FI?ACP, FACA, International Organization for Standardization, ISO, compounded sterile preparations, aseptic compounding, air quality, air changes per hour, sterile hood, certification testing

Related Categories: ENVIRONMENTAL , STERILE PREPARATIONS, QUALITY CONTROL, UNITED STATES PHARMACOPEIA CONVENTIONS

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