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Safer Sterile Compounding: Choosing and Using Disinfectants for the Cleanroom

Author(s):  Kastango Eric S, Douglass Kate, Patel Kedar, Givehchi Babak, Brister Paul, Postlewaite Jay, Taraban Laura

Issue:  Jul/Aug 2015 - Volume 19, Number 4
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Note:  Electronic version includes supplemental material.

Abstract:  Compounders worldwide are responsible for ensuring that the sterile preparations they dispense are pure, potent, and safe. To achieve that result, proper cleaning and disinfection of International Organization for Standardization controlled environments must occur. Because those tasks must be performed according to established standards, the compounding pharmacist must research regulatory requirements and appropriate products for use. In this report, we focus on U.S. regulations, guiding entities, and effective products that enable compliance with the increasingly stringent procedures required for pharmaceutical compounding. We also review cleaning and disinfecting processes, discuss the importance of correctly choosing and using disinfectants and/ or sporicidal disinfectants with surface claims in the cleanroom, and provide answers to questions frequently asked by staff who use those agents. In addition, we profile specific disinfectants that are compliant with United States Pharmacopeia Chapter <797> and current good manufacturing practice standards. Biological safety cabinets and compounding aseptic containment isolators must undergo an additional process that deactivates hazardous drug residues and removes them from the interior surfaces of those devices before they are cleaned and disinfected, but that discussion is beyond the scope of this article.

Related Keywords: Eric S. Kastango, MBA, RPh, FASHP, Kate Douglass, MS, RN, CRNI, Kedar Patel, BS, Babak Givehchi, M Env Sci, RAC, Paul Brister, PhD, Jay Postlewaite, PhD, Laura Taraban, MD, cleanroom, cleaning, disinfectants, disinfecting, compounded sterile preparations, sporicides, U.S. Pharmacopeia Chapter <797>, USP, standards, good manufacturing practices, GMP, biological safety cabinets, aseptic containment isolators, hazardous substances, drug safety, microbial contamination, primary engineering controls, cleaning tools and implements, sterilants, bactericides, 70% isopropyl alcohol, sterile compounding area, sanitizers, chlorine, oxidizing agents, hydrogen peroxide, dwell time, disinfection, environmental safety, peracetic acid, phenolic agents, quaternary ammonium, FAQs, sterile water


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