2019 New General Chapter USP <60> Tests for Burkholderia Cepacia Complex, 15th January 2020
: 15 Jan 2020
Burkholderia cepacia and its BCC Complex are bacterial species that are ubiquitous in nature and often found as a frequent recall issue based upon CDER data. Pharmaceutical products that are contaminated with B. cepacia and/or its Complex may pose serious issues to infants, elderly and immunocompromised individuals. Preventing B. cepacia contamination in drugs by addressing the potential sources of this Complex in a drug manufacturing operation is an important public health goal.
Historically, when the USP was revised in May 2009, it was modified to include both USP<61> and USP<62>, and harmonized with both the European Union (EU) and Japanese Pharmacopeia (JP). B. cepacia was excluded at that time as a “specified” bacterium – even though many individuals believed that it should have been included. In addition, it was not included within USP<1111> when it also was modified several years ago. One of the main reasons that all believed that it should have been included was because of the frequency in which it occurs and the diversity of environments and products in which it has been found.
The method of transmission through direct contact with other individuals includes the shaking of hands and even body perspiration. Although B. cepacia does not appear to survive on completely dry surfaces for more than one week, it can survive for many months in water. B. cepacia can use other routes of transmission including contact with hard surfaces. Perhaps most important to note is this microbe’s ability to remain viable under harsh conditions (e.g., organic solvents, antiseptics, low nutrients, etc.) for many months. Given the robust nature of the organism, it is important to consider the relatively high patient risk when this microorganism is present in manufacturing equipment, components, or the process water used in manufacturing pharmaceutical products.
The new draft General Chapter USP <60> which became official on December 1, 2019 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.
The objective of this live, interactive training webinar is to explore the various issues surrounding the history of B. cepacia and its Complex and examine solutions to common microbiological problems. It will discuss the draft General Chapter USP<60>, media that is proposed, genotypic consideration as well as recalls, FDA 483s and Warning Letters. Please plan to bring an interdisciplinary team to this training session to explore how knowledge regarding this contaminant and its Complex may assist you in your facilities and minimize it as an objectionable microorganism/group.
- A review of the pertinent history of B. cepacia/Complex.
- Extensive review of the process involved in the isolation and identification of B. cepacia/Complex.
- Explore the “new” recommended medium for propagation of this microorganism and its Complex.
- Learn why USP<60> does not provide a sufficient identification (genus/species).
- Use of B. cepacia within USP<1111> as a potential monograph addition.
- Experience what Companies have encountered with Recalls, Form FDA 483s and Warning Letter examples.
- Case studies of Warning Letters with B. cepacia/Complex.