Thursday January 30, 2020
12:00 pm – 1:30 pm EST
Instructor: Barry A. Friedman, Ph.D
Monitoring of in-process bioburden of pharmaceutical components, containers and closures, intermediates, drug substances and drug products is an essential element of the overall contamination control program for appropriate process control of both non-sterile and sterile products.
A typical bioburden control program includes review and analysis of potential sources of contamination commencing with each of the raw materials to include the Certificate of Acceptance of each. The microbiological contamination control program should be developed to identify and control bioburden and to assess product risk based on ICH Q9 Quality Risk Management. The bioburden risk assessment should result in the establishment of a range of critical control points which will ultimately lead to specifications for each raw material and to each unit operation as well as the drug substance (DS) and product (DP).
Several of the major risk assessments should include:
- Microbiological attributes of in-coming raw materials and manufacturing unit operations within the process itself
- Antimicrobial effectiveness of the raw materials
- Duration of the process
- Water activity of the material
- Environmental conditions within the facility
- Equipment design and cleaning to maintain a low bioburden
- Sanitization, disinfection and sterilization, as appropriate
Bioburden should be recovered and enumerated from samples that are representative of each container of in-coming raw materials. When multiple containers of in-coming raw materials are received, they should be analyzed based on a plan developed in concert with Quality Assurance and Quality Control. When the material is stored in separate containers, analysts should consider testing multiple or composite samples.
Bioburden evaluation should focus on microorganisms that represent specified and objectionable microorganisms. Total count methods should consider bacteria, yeast and mold.
Controlling the bioburden of the in-coming raw materials, drug substance and drug product will ensure conformance to the levels required for the various in-process and final product. Additionally, controlling the bioburden levels of the items if the API is to be sterilized assures that residuals (e.g., allergens, endotoxins, and exotoxins) from that population will also be controlled.
The objective of this live, interactive Executive Conference Corp. training webinar is to obtain an enhanced understanding of the monitoring of bioburden, its inherent methodology, and limitations to assure that the test is being applied as appropriate per United States Pharmacopeia and how to interpret the final result. It will also consider methods of sterilization as a function of component bioburden and endotoxin. Please consider having a cross-functional team attend this important webinar.
By attending, you will learn about the:
- Examination of a Bioburden Control Program
- Major Elements of a Bioburden Control Program
- What a Vendor Can Tell You through a COA
- What Your Bioburden Evaluation is Telling You
- What Your Bioburden is Telling You about Each Unit Operation
- How Your Bioburden Impacts both Non-Sterile and Sterile API and Final Products
- Interpretation of the results – regardless of a pass or failure.
- Review of pertinent Warning Letters.
Those who should attend include:
- Microbiologists
- Quality Control personnel
- Quality Assurance
- Regulatory Compliance
- Manufacturing
- Research and Development
- Project Management
$385 for one person
$700 2-5 people
$999 6-10 people
Questions? support@eccwebinars.com
ECC-162