The identification of microorganisms plays a fundamental role to define causes of sterility testing failures or to determine sources of ongoing microbial investigations. The presence or absence of specified microorganisms in a product is relevant to determine whether a substance or preparation complies with an established specification for microbiological quality. The importance of achieving the microorganisms identity is esplicated in the most relevant Guidances, Regulations and Testing standards applied to pharmaceutical, medical device, biocides and cosmetic industry.
One of the most ubiquitous bacterial species in nature associated with numerous health issues is Burkholderia cepacia and its BCC Complex. Pharmaceutical products contaminated with B. cepacia and/or it’s complex may pose serious consequences to vulnerable patients. Given the robust nature of the organism preventing B. cepacia contamination in drugs by addressing the potential sources of this complex in drug manufacturing is a public health goal.
Pharmacopeial Forum designed a new draft General Chapter USP<60> “Microbiological Examination of Nonsterile Products—Tests for Burkholderia cepacia Complex” designed as an extension of USP <61>/<62> that focuses on the probability of detection of the BCC over the methods described in USP<62>. The newer technology emphasizes the use of recA to identify the microorganisms.
The focus of this Workshop is to explore the «state of the art» to identify microorganisms including the BCC “cluster” in order to avoid out of trends, sterility test failures or other product failures and provide useful knowledge to determine which method can be more appropriate for use in your site.
Practical case studies and examples from our extensive daily analytical activities, developed within our center of excellence in Microbial Identification, will be presented to illustrate main topics and real lab-life aspects.
The Workshop led by our higly skilled experts in Eurofins IDMYK and Eurofins Biolab will also give the opportunity to bring your specific questions and case studies along to the course for discussion and to help to determine a resolution in order to enhance the learning experience.