Education Sessions

E-MG8
Bioburden Concerns in Aseptic Processing

6 November 08.15-11.30 Track: Manufacturing

ISPE CEUs: 0.2

Look “behind the curtain” of control levels and guidance documents at the rationale and scientific justification for microbial control levels in aseptic processing. The presenters are recognized experts in the field of microbiological monitoring with strong experience in the regulatory, scientific and practical
aspects of the topic.

You cannot afford to miss this because so many of the expectations for ongoing performance criteria of the aseptic processing facility relies on data derived from microbiological monitoring. Unfortunately, there are many misconceptions about these data and how to apply the information derived, both in ongoing monitoring programs and as an aid in investigations.

Microbiology and bioburden concerns play a role in the design and execution of aseptic processes. This concern starts at the level of facility design, and extends
through raw material control, in-process monitoring, and personnel considerations. Explore scientific, as well as regulatory concerns, with emphasis on the aseptic processing guidance document from US FDA, recent 483 observations, USP guidance, and the scientific basis for the regulatory concerns.

These presentations are geared to learners not intimately involved in microbiology, but whose job functions require an understanding of the underlying principles for the regulatory considerations. Discuss key presentation points.

Take Back to Your Job

  • Recognize the many misconceptions of data derived from microbiological monitoring that can critically impact aseptic processing
  • Correctly apply the information derived, both in ongoing monitoring programs and as an aid in investigations
  • Understand key risk factors in aseptic processing in relation to microbial contamination and implications, and pertinent regulatory concerns in regards to environmental contamination in aseptic processing, and the scientific basis for those concerns
  • Evaluate the tools available for environmental monitoring of viable counts in the aseptic arena, and understand their respective strengths and limitations

Who Should Attend

Microbiology laboratory supervisors, microbiologists responsible for testing and release of pharmaceutical, parenteral and medical device products; regulatory and compliance personnel responsible for auditing of manufacturing facilities; and engineering professionals responsible for contributions to the successful operation
of aseptic facilities.

Communities of Practice: Process Analytical Technology (PAT) and Sterile Products Processing (SPP)

Agenda Topics

  • The Role of Microbiology in Aseptic Processing
  • The FDA Aseptic Processing Guidance Document
  • USP Perspective on Microbial Control of Aseptic Processing
  • Microbial Monitoring of the Environment: Strengths, Limitations and Role in PAT

Session Leader

  • Scott Sutton, Sr. Director, Microbiology Services, Vectech Pharmaceutical Consultants, Inc.

Session Speakers

 

Sponsors