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Application note

Application note: The need for rapid methods in the compounding pharmaceutical industry

This application note explores rapid microbial methods and balancing patient care, quality products, and safe shelf lives for unique formulations.

USP chapter <797> “Pharmaceutical Compounding – Sterile Preparations” has been effective for a year and the massive overhaul of the parameters used to assign beyond-use dates (BUDs) is no longer a surprise. In most cases, compounded products will have shorter shelf lives. This heavily impacts batch planning and availability to patients, yet there are some ways to extend the BUDs that are outlined in the new revision. Most notably, performing a sterility test on each lot can often double the BUD window. However, waiting for a sterility test takes at least two weeks, which significantly cuts into that window.

Another seemingly minor change can also help alleviate this issue. First, let’s look at the previous version of the chapter: in that version, there was a single line buried in the sterility test section that briefly mentioned alternative methods. “A method not described in the USP may be used if verification results demonstrate that the alternative is at least as effective and reliable as the USP Membrane Filtration method or the USP Direct Inoculation of the Culture Medium method where the Membrane Filtration method is not feasible.” That previous reference offered no direction for demonstrating method effectiveness. Without direction as to what will be accepted by relevant regulatory bodies, the reference was nearly useless. It is difficult to invest in a project without a clear road map for approval. 

Download this application note to discover more about:

  • Alternative rapid methods
  • Shelf-life considerations
  • Beyond-use dates (BUDs)

 

About the author

Jon Kallay is Senior Scientific Portfolio Specialist, Microbial Solutions, Charles River.