Aseptic technique: the foundation of sterile compounding
Aseptic technique is a set of methods used to prevent microbial, particulate, and other contamination during sterile compounding. In practical terms, aseptic technique includes appropriate hand hygiene and garbing, disinfection of supplies and critical sites, proper workflow within the ISO Class 5 PEC, and consistent protection of first air during every step of producing compounded sterile preparations.
Core aseptic technique practices
As a starting point, all personnel entering the sterile compounding area must remove personal outer garments and all items that may contribute particles or interfere with garbing, including cosmetics, jewelry, artificial nails and polish, earbuds, and other exposed accessories.
Hand hygiene remains a critical step. All personnel entering a compounding area must clean underneath fingernails under warm running water, wash hands and forearms up to the elbows with soap and water for at least 30 seconds (use a timer to ensure compliance!), and dry with low-lint disposable materials. Hand dryers must not be used, and disposable soap containers must not be refilled or topped off in a way that increases contamination risk. After handwashing, hands must be sanitized with an alcohol-based hand rub and allowed to dry thoroughly before donning sterile gloves. Sterile gloves must be donned in a classified room or segregated compounding area (SCA).
USP <797> no longer prescribes a single universal garbing sequence. Instead, the compounding facility must determine the garbing order based on sink placement and workflow and document that sequence in its standard operating procedures (SOPs). Pharmacy compliance platforms like Simplifi 797 allow the compounding facility to create customized SOPs and competency assessments that ensure staff are properly garbing based on the facility’s unique design and workflows.
Disinfection and first air
Disinfection is central to proper aseptic technique for sterile compounding. Sterile 70% IPA (sIPA) must be used to wipe any item just before introduction into the PEC, as well as any critical sites such as vial stoppers, ampule necks, and IV bag septums. sIPA is also applied to gloves and horizontal work surfaces of the PEC at least every 30 minutes plus anytime the glove hands leave the PEC and prior to re-entry to minimize microbial contamination of the compounding environment.
Aseptic manipulations occur in the direct compounding area (DCA) in a manner that maintains first air. First air is unidirectional clean air direct from a HEPA filter that, when unobstructed, maintains sterility in the DCA of the PEC. Critical sites, including IV bag ports, vial septums, syringe tips, and needles, must be positioned so that unidirectional HEPA-filtered air reaches them without obstruction, and operational workflow should minimize interruptions or hand placements that block first air at the DCA.
Initial qualification: Garbing, hand hygiene, aseptic manipulation
One of the most important pieces of a successful sterile compounding program is personnel training and competency. Personnel must complete training and be able to demonstrate knowledge of hand hygiene, garbing, cleaning and disinfection, and aseptic technique prior to compounding independently. Investing in interactive, readily available competency training like Simplifi’s SoleSource Academy Continuing Education collection can help ensure your staff has the tools to gain knowledge on sterile compounding topics and prepare competency testing through review of training videos.
Initial qualification involves demonstrations of competency in garbing, hand hygiene, and aseptic manipulations. Compounders and personnel who directly oversee compounders must successfully complete an initial garbing competency evaluation no fewer than three separate times in succession. A garbing competency evaluation includes both visual observation and gloved fingertip and thumb sampling (GFT) of both hands. Any failure during the competency evaluation must be documented and remediation and repeat evaluation until three successful demonstrations are completed.
Compounders and personnel who directly oversee compounders must successfully complete an aseptic manipulation competency evaluation. An aseptic manipulation competency evaluation includes both visual observation, media-fill testing, post-media-fill GFT of both hands, and surface sampling of the DCA. Media-fill testing is used to evaluate whether compounding personnel can perform aseptic manipulations without introducing microbial contamination. Any failure during the competency evaluation must be documented and remediation and repeat evaluation until all parts are successfully completed.
A strong media-fill program should simulate the most difficult and challenging aseptic compounding procedures encountered during a facility’s sterile compounding operations. Generic kits may be convenient, but a simulation closely reflecting the facility’s real compounding processes provides a more meaningful assessment of aseptic skill. If using commercial sterile microbial growth media, a certificate of analysis (COA) must be obtained from the supplier stating that the lot of the growth media will support the growth of microorganisms.
Ongoing qualification: Garbing, hand hygiene, aseptic manipulation
Specific sterile compounding competencies require more frequent assessment and qualification, based on the category of compounding performed. The table below describes the minimum qualification frequencies by personnel function. For other personnel functions, including those who restock or clean the sterile compounding areas, please refer to the current, effective USP <797>.