These standards include three key statements that we will discuss further in this two-part series:
Cleaning and disinfecting agents used in the PEC (Primary Engineering Control) must be sterile.
Cleaning and disinfecting agents used in the SEC (Secondary Engineering Controls) or SCA should be sterile.
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).
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.