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The United States Pharmacopeia is finalizing revisions to Chapter 797 on sterile compounding for release this summer. The updated chapter will be released in two parts.
"Most of the revisions have been approved by the [sterile compounding] committee," Newton told a standing-room-only audience at the recent ASHP summer meeting in San Francisco. The approved sections will be posted on the USP Web site this summer and take effect about six months later, he said. Sections on disinfectants, cleaning, and environmental monitoring are still being revised and will be posted later this year.
Much of the new material in Chapter 797 focuses on two areas: contact contamination and air quality in sterile compounding areas. Many of the revised standards, Newton said, are based on good manufacturing practices (GMPs) that have long been required in sterile pharmaceutical manufacturing facilities, semiconductor fabrication facilities, and other ultra-clean environments. Those GMPs include universal use of masks, gloves, gowns, booties, hair nets, and beard nets; prohibitions on makeup and jewelry; universal disinfection of the outside of all vials and containers; rigorous exclusion of beverage or food containers from less clean areas; and absolute prohibition on entering sterile areas wearing any items that have been worn in less clean areas.
Hand hygiene has been identified as a key factor in maintaining sterility, Kastango said. The typical human hand harbors an average of 100,000 organisms per square millimeter. Even tiny tears or micro-punctures in sterile gloves can unleash a flood of microorganisms.
The committee's solution is twofold: antiseptic hand washing with an agent that leaves an antimicrobial film on the hands, plus periodic disinfection of sterile gloves with 70% isopropyl alcohol. The antiseptic hand wash reduces contamination through unnoticed gaps in glove protection. The frequent glove disinfection guards against unintentional contamination from touching the body.
"We all know that sterile gloves do not remain sterile," Newton said. "People unconsciously touch their nose, ears, or eyes. Regular disinfection of gloves significantly reduces the bioburden and the potential for subsequent contamination."
Also new are requirements for multi-use and single-use containers. Single-use vials used once are always safer, Kastango said. Because the vial is opened only once, there are no concerns about contamination and microbial growth within the container.
The beyond-use date (BUD) for multi-dose containers is defined as 28 days from first opening unless otherwise specified by the manufacturer. The BUD for single-dose containers depends on the container and where it is opened.