BRIEFING

 〈73〉 ATP Bioluminescence-Based Microbiological Methods for the Detection of Contamination in Short-Life Products. This new chapter proposal is based on the version published in PF 46(6) as "ATP Bioluminescence-Based Rapid Microbial Methods for the Release of Short Shelf Life Products". The previous proposal has been canceled and is being replaced by this updated version, which includes the following revisions by the Microbiology Expert Committee:

1. Change the title to "ATP Bioluminescence-Based Microbiological Methods for the Detection of Contamination in Short-Life Products".

2. Change the requirements of the selection of culture media and incubation temperature to align with existing USP chapters.

3. Add more requirements in the Method Suitability Test to include the following:

   1. Inoculation of test microorganisms at not more than 10 CFU.

   2. Specification that the list of microorganisms in Table 1 is the minimal requirement. Inclusion of product- and processing-relevant strains and local isolates should be considered with appropriate risk-based justification.

   3. Specification that positive control and negative controls should be included in the suitability test.

4. Guidance for the direct inoculation of the culture medium and membrane filtration when testing for the microbial detection in the product to be examined.

5. Introduction of a safety margin concept to determine the longest time to detection.

 The companion chapters Respiration-Based Microbiological Methods for the Detection of Contamination in Short-Life Products 〈72〉 and Rapid Microbial Tests for Release of Sterile Short-Life Products—A Risk-Based Approach 〈1071〉 also appear in this issue of PF.

 (GCM: H. Tu)

 Correspondence Number—C326605