The latest updates to USP Chapter <797> have brought significant changes to the landscape of sterile compounding pharmacies and cleanroom operations. In this blog post, we'll explore the key updates from the chapter and discuss their implications for pharmacies. You can also learn more about USP Chapter <797> Compliant Cleaning Procedures here.
Key Update 1: Sterile Products within the PEC
One of the most notable changes is the requirement for sterile products within the Primary Engineering Control (PEC). Previously, only alcohol used in compounding needed to be sterile, but now, both the disinfectant and wipes/applicators must be sterile.
Key Update 2: Frequency of Cleaning and Disinfecting
Chapter 7 specifies the required cleaning frequency and locations for compounding areas. In a Primary Engineering Control (PEC), sterile 70% IPA must be applied after cleaning and disinfecting or following the use of a one-step disinfectant cleaner or sporicidal disinfectant, to remove any residue. Sterile 70% IPA must also be applied immediately before starting compounding. During compounding, sterile 70% IPA must be applied to the horizontal work surface, including removable work trays, of the PEC at least every 30 minutes if the process takes 30 minutes or less. If the process exceeds 30 minutes, disinfection must occur immediately after compounding.
Key Update 3: Garbing Requirements
Section 7 of the chapter addresses cleaning and disinfecting activities being performed by trained and appropriately garbed personnel. Staff must use facility-approved agents and procedures, which must be described in written SOPs. The frequency, method(s), and location(s) of cleaning, disinfecting, and applying sporicidal disinfectants must be established in written SOPs. The minimum contact time must be followed for each of the cleaning, disinfecting, and sporicidal disinfectants used.
Key Update 4: Introduction of Items into Cleanrooms
The chapter now includes specific guidelines for introducing items into cleanrooms and segregated compounding areas (SCAs). Items must be wiped with a disinfectant, sterile IPA, or sporicidal agent before being brought into the cleanroom to minimize the risk of contamination. This step is essential for maintaining a state-of-control for compounding activities.
Key Update 5: Support for Implementing Change
To assist pharmacies in implementing these changes, Contec Healthcare is offering a range of resources and support. From training videos to task sheets and online learning platforms, we are committed to helping pharmacies navigate the transition smoothly. You can access these sources here: Resource Center | Contec Healthcare (contecinc.com)
In conclusion, these updates to the USP Chapter have significant implications for compounding pharmacies. By adhering to these new requirements for sterility, cleaning, and garbing, pharmacies can ensure the safety and quality of compounded medications. With support from Contec Healthcare, pharmacies can successfully navigate these changes and continue to provide essential healthcare services to their patients.
For more information on USP Chapter <797> visit our USP web experience here.
