Sanitizing Aseptic Compounding Consumables
Posted on July 2, 2014
Craig A. Boyce , RPh
All consumables entering into an ISO-7 buffer zone must be sanitized by saturating the object with sterile isopropyl alcohol (sIPA) and wiping, leaving an adequate residual amount of sIPA so that the object remains wet for at least 30 seconds to kill viable organisms. Upon introduction into the ISO-5 zone, sanitizing of the critical site just prior to penetration must be performed a second time and the critical site held in first air. Throughout each step, personnel must also routinely sanitize the gloved hands to prevent touch-transfer contamination and pay particular attention that first air above a sanitized object is not violated.
Observations of this process show a wide disparity in the quality of sanitizing performance. Despite USP<797> explicitly requiring non-shedding sterile IPA wipers, it is still common to see IPA gauze pads used for sanitizing critical sites. Not only do these pads shed particles, but also there have been numerous instances in the last decade of contaminated IPA gauze pads. Another flaw in the process is failure to adequately wet the object. It is not uncommon to see personnel “mist” rows of vials in a hood and immediately begin using them for compounding. Violation of first air above a critical site is another common failure.
Particularly concerning are labels and the supplies that are introduced into the ISO-5 zone in a protective overwrap. It is a common misconception that these items do not require sanitizing because only the content of the package will be used in compounding. Studies have shown that 60% of consumables are contaminated with bacteria and 20-40% are contaminated with bacterial spores. Since IPA cannot reliably kill spores, the current alcohol-based process is not ideal for preventing spore contamination during aseptic manipulations.
Facilities should perform risk assessment of the sanitizing process by auditing personnel during the consumable cleaning process. Routine culturing of pre-cleaned and post-cleaned consumables can allow a facility to determine baseline bioburden of consumables, effectiveness of the sanitizing process, and residual risk.
A more comprehensive approach to risk reduction is to use automation such as the RIVA Fully-Automated IV Compounding System that employs high-intensity pulsed UV light. The patented RIVA Port Disinfection System has been validated to kill both vegetative organisms and spores on critical sites. Additionally, the automation controls ensure that the disinfected site remains in first air during the entire compounding process.
More information on RIVA can be found at www.intelligenthospitals.com.
Craig Boyce is a pharmacist on staff at Intelligent Hospital Systems, designer and manufacturer of RIVA a Fully Automated IV Compounding System
M. G. Cockcroft, D. Hepworth, J. C. Rhodes, P. Addison, A. M. Beaney. “Validation of Liquid Transfer Disinfection Techniques for Transfer of Components Into Hospital Pharmacy Cleanrooms,” Hospital Pharmacist (September, 2001).
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