BRIEFING

 〈1119〉 Bioburden Monitoring. The General Chapters—Microbiology Expert Committee is proposing this new chapter for monitoring of bioburden. This chapter provides guidance for the monitoring and testing of bioburden, including recommended limits for bioburden. The chapter distinguishes the differences from Microbial Enumeration Tests 〈61〉, which is purposed for the testing and release of nonsterile products and nonsterile substances for pharmaceutical use in accordance with Microbiological Examination of Nonsterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use 〈1111〉. This chapter contains information for the proposed test method chapter Bioburden Test 〈1119.1〉, sampling, and recommended bioburden limits. Although Monitoring of Bioburden 〈1229.3〉 suggests that appropriately modified and qualified versions of 〈61〉 might be used for testing bioburden, there are no details or directions on how to achieve this. This chapter and 〈1119.1〉 provide a solution. Information from the currently official 〈1229.3〉 is included in this chapter, and a proposal to omit 〈1229.3〉 will appear in this PF. The scope of this chapter includes any material subject to a test for bioburden that is not used for the release testing of finished product. This includes, but is not limited to, in-process samples, drug substances, components, and water. The purpose of bioburden monitoring is to ensure that an item consistently meets the required acceptable limit for bioburden.

 The proposed recommendations are aligned as much as feasible with relevant health authority expectations. Although a single bioburden test method will appropriately quantify mesophilic aerobic microorganisms as a total aerobic microbial count (per 〈1119.1〉), stakeholders may need to adapt the bioburden test to quantify a different anticipated microbial population. This chapter provides guidance for these modifications in those circumstances.

 Additional proposals in this issue of PF include:

1. Addition of a new chapter Bioburden Test 〈1119.1〉.

2. Omission of Monitoring of Bioburden 〈1229.3〉.

 (GCM: L. Furr)

 Correspondence Number—C325458