By: Barry A. Friedman, PhD LLC
Pharmacopeial Forum (PF, September/October 2018, 44(5)) published a new, proposed General Chapter (USP<60>) on B. cepacia Complex entitled “USP<60> Microbiological Examination of Nonsterile Products—Tests for Burkholderia cepacia Complex”. The proposed PF chapter represents an expansion of USP<62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms. It is planned to issue as USP<60> on Dececmber 1, 2019.
Because USP<62> is a harmonized chapter with the European Union and Japan, the USP Microbiological Expert Committee recognized it would be difficult and time consuming to modify it to address the B. cepacia Complex (BCC) issue. At the same time the USP Microbiological Expert Committee recognized that USP<62> was inadequate for determining the presence/absence of the BCC which is often a contaminant of water, preserved aqueous and oral liquids, and topical products.
This new Chapter is designed as an extension of USP<61>/<62> General Chapters and to increase the probability of detection of the BCC over the current methods described in USP<62>. While this Chapter will not provide for speciation of the BCC, it will provide methodology to provide a presumptive identification based upon verification/qualification.
Genotypic methods are available today that will provide speciation for as many as 23 different microorganisms within the BCC, but require more effort than the initial 500 base pairs available with the 16s rRNA. The newer technology emphasizes the use of recA to identify the microorganisms within this BCC “cluster”.