New USP Requirements — Are you Ready??

In preparation of USP revisions, labs across the US are making changes to ensure compliance. There are many new requirements with the potential to cause significant disruption to cleanroom operations.

One of the more significant changes is found in section 6.3 of USP 797: Monitoring Surfaces for Viable Particles. The revision makes a clear requirement for a monthly surface sampling of classified areas, including: USP

  • The interior of the PEC and the equipment contained within it
  • Staging or work areas near the PEC
  • Frequently touched surfaces

Samples must be taken at the end of the compounding activity but before the area has been cleaned and disinfected. Thus, it will place greater importance on both operator aseptic technique and in-place contamination control programs. Cleanrooms will have to concentrate on both areas to prevent positive biological growth.

People are the main contributors of contamination; so, operator aseptic technique will be the main focus. Correspondingly, the revisions specify an increase in operator training and testing frequency to help identify and correct poor procedure.

A robust contamination control program will also be critical. Operator training should include GMP cleaning and disinfecting techniques, knowledge of contamination and its sources, and proper preparation of chemicals. Typically, this responsibility falls on the pharmacy/lab technicians. However, their efforts may not be enough.

In addition to daily cleaning by the in-house team, it can be prudent to engage dedicated cleaning and disinfectant team trained and specialized to the task. This team can address areas of the cleanroom envelope beyond technicians’ workstations and frequently touched surfaces. Frequency would be based on the dynamics of the cleanroom operation.

As a final step in contamination control, the new USP revisions mandate the application of sporicidal agents. In place of the traditional spray-and-wipe method, monthly or quarterly dry fog applications can help ease some of the burdens of this requirement. Not only does vapor delivery reduce cycle-time, it is more effective and covers all areas—including those often missed or simply inaccessible during routine disinfection.

The new standards are available online from USP at Sterile Science is ready to assist you with the new cleaning, disinfection and sterilization requirements.

© Sterile Science LLC, All rights reserved • Privacy Policy