Sterile Disinfectants: Part Two

The 2022 version of USP <797> (effective November 1, 2023), provides new standards for the use of cleaning and disinfecting agents in the classified areas of cleanrooms and segregated compounding areas (SCAs).

These standards include three key statements that we will discuss further in a two-part series:

1. Cleaning and disinfecting agents used in the PEC (Primary Engineering Control) must be sterile.
2. Cleaning and disinfecting agents used in the SEC (Secondary Engineering Controls) or SCA should be sterile.
3. Sterile cleaning and disinfecting agents and supplies may be reused once opened, but only for a period specified by the manufacturer and/or described in the facility's written Standard Operating Procedures (SOPs).

Managing Sterile Supplies in the PEC

Untitled design (15) Once sterilized items are opened, strictly speaking, they are no longer considered sterile. However, it is crucial to find an effective way to maintain a bottle or pouch of cleaning or disinfecting supplies. Storing multiple items in the PEC can increase the risk of compromising air flow and reduce the effective working area. Contec Healthcare has conducted studies and created a technical bulletin that outlines how bottles and pouches can be properly closed to reduce the risk of microbial contamination after opening. For bottles of cleaning agents, it is a simple process to remove closed bottles from the PEC and store them nearby. For pouches, the process is not as simple, but the peel-reseal pouches have a low profile that is less problematic to disruption of airflow when stored inside the PEC. Please contact your local technical sales representative for Contec Healthcare products to learn more.

Additional Resource for best practices and insights for safe handling of materials:

To Wipe or not to Wipe: A Guide to Material Handling in a Sterile Compounding Cleanroom

Managing Sterile v. Non-sterile Versions

Cleaners and disinfectants that have been validated to be sterile are more expensive than their non-sterile counterparts. Therefore, many facilities choose to use sterile versions only in the Primary Engineering Controls (PEC). Although it is recommended to use sterile products throughout the cleanroom, it is not mandatory under USP <797>. However, managing separate inventories of sterile and nonsterile versions of both daily disinfectants and sporicides can be challenging. While sterile versions of Contec products are clearly marked on the containers, it is acceptable to further differentiate sterile vs. non-sterile or designate a sterilized item for use only in the ISO 5 area by using appropriate markers or labels. Alternatively, some facilities may choose to use sterile disinfectants throughout the entire cleanroom suite to simplify inventory management.

For more information on this topic, watch our Webinar, Compounding with Confidence: Understanding EPA Registration and Sterile Products where we address key topics such as the importance of using EPA registered disinfectants, the meaning of ‘validated sterile’ products and the differences between irradiated and sterile products.

To catch up on Part I of this 2-part series, click here.