For further information, see Hand Hygiene and Garbing for Nonhazardous Sterile Compounding in the September issue of Pharmacy Purchasing & Products (PP&P), as this article builds on the information presented therein.
When performing hazardous drug (HD) sterile compounding, it is vital that both the sterile compounding environment and the compounded sterile preparations (CSPs) are protected from microbial bioburden, while simultaneously achieving protection of the workers and the environment outside of the containment secondary engineering controls (C-SECs) through containment of HD residues. Containment is realized through the use of properly functioning primary and secondary engineering controls, as well as proper work practices, including a precise approach to donning and doffing personal protective equipment (PPE).
Although USP details garbing requirements in General Chapter <797> Pharmaceutical Compounding—Sterile Preparations and <800> Hazardous Drugs—Handling in Healthcare Settings, additional clarification may be valuable to practitioners. As such, the following details key points in the garbing process, including step-by-step doffing instructions that are not widely available.
- This article, Part 1, includes best practices for hand hygiene and donning PPE in HD sterile compounding
- Part 2, which will be published in a future issue of PP&P, will include best practices for doffing PPE in HD sterile compounding
Donning garb for HD sterile compounding differs depending on whether the pharmacy performs HD compounding in an HD buffer room (ISO 7, negative pressure) or in a containment segregated compounding area (C-SCA; non-ISO classified, negative pressure room with at least 12 air changes per hour). The following steps note the differences as they apply.
A video of proper donning of two pairs of HD gloves is available at the CriticalPoint Web site at: https://www.criticalpoint.info/video/donning-double-hd-sterile-gloves/
Click here to see Photo 1
Click here to see Photos 2-5
Click here to see Photo 6
Click here to see Photos 7-8
Click here to see Photos 9-11
Click here to see Photos 12-16
Regular observation of staff practices is key to ensuring ongoing compliance to proper PPE practices.
Kate Douglass, MS, RN, CRNI, is the vice president of CriticalPoint, LLC, and serves as the co-director of the annual USP <797> and <800> Compliance Studies.
Developing a USP <800> Compliance Gap Analysis
Best Practices for Garbing in HD Sterile Compounding: Part 2—Doffing PPE
Pre-Employment Screening to Prevent Diversion
Evaluating 503B Outsourcing Providers
Refining PPE Usage for HD Compounding: Part I
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