Burkholderia cepacia - Risks in Context for Non-Sterile Pharmaceutical Products
Duration: 60 Minutes
Burkholderia cepacia complex (BCC) organisms can survive or multiply in a variety of non-sterile and water-based products because it is resistant to certain preservatives and antimicrobial agents. This makes the organism a risk in terms of non-sterile aqueous products. Detecting BCC bacteria is also a challenge and requires validated testing methods that take into consideration the unique characteristics of different BCC strains. This webinar discusses where the organism may be found, how to detect it and what to do if it is present in the manufacturing environment.
Objectives of the Presentation
Why Should you Attend
- The origins of Burkholderia cepacia in pharmaceuticals and healthcare
- Risks to patients
- The link to pharmaceutical product recalls
- The need to design a testing regime
- The use of rapid methods for detection
- Strategies for method validation
- The importance of a holistic contamination control strategy
Drug manufacturers of non-sterile, water-based drug products have seen recent product recalls due to Burkholderia cepacia complex. Regulatory agencies expect pharmaceutical manufacturers to be testing environments, water and products for the organism and putting remedial measures in place. In order to test effectively, microbial methods need to be suitably qualified. The qualification of methods is challenging. Attend this webinar to learn more about this microorganism of concern, and to learn about its origins, risk factors, means of mitigation and methods of detection.
Who will Benefit
- What is Burkholderia cepacia?
- Patient risks
- Product recalls
- Where Burkholderia cepacia is found in the pharmaceutical environment?
- How to test for the organism, using conventional and rapid methods
- How to qualify methods
- Remediation strategies should contamination occur
- The need for a contamination control strategy
- Quality assurance
- Quality control
- Production managers
- Medical staff
- Infection control
- Production managers
- Production staff
- Maintenance / engineer staff
- Pharmaceuticals - sterile and non-sterile