Failure or OOS Investigation for Sterility or Bioburden Testing

FACT:
Sterile products all require some level of sterility and Bioburden testing during validation and then during routine production. At some point this testing is likely to exhibit results that do not meet specifications and it may occur during process definition, validation, requalification, dose audits or during routine performance. It is important to know what actions should be taken to investigate these potential failures or out-of-specification conditions to identify the root cause. It is also critical to know what course of action can be applied to evaluate the acceptability of product for release.

This presentation will review the various items that should be investigated to determine the root cause when a failure occurs during a sterility test for biological indicators during validation or routine processing for EO sterilization processes, during a test of sterility following a verification dose either initially or during a dose audit or when the product Bioburden level exceeds the alert or action levels that have been established for the product. It will also cover the actions to be taken as a follow up to the investigation.

Areas Covered in the seminar:

• Is the test result a failure to be investigated?
• What items should be investigated during validation for EO sterilization and radiation sterilization
• What actions can be taken during validation following a failure.
• What items should be investigated following a BI positive in a routine EO cycle and what actions should be taken.
• What items should be investigated following a dose audit failure and what actions should be taken.
• Investigation of a bioburden out-of-specification condition.
• What actions should be taken following an alert or action limit excursion.
• Evaluation of the bioburden OOS on sterilization.

Who will benefit:

This webinar will provide valuable information to all companies that produce sterile products.

• QA personnel
• Validation specialists
• Manufacturing personnel involved in validations
• R&D specialists

Instructor Profile:
Gerry O’Dell, is President of Gerry O’Dell Consulting, a consulting firm based in the United States with clients around the world. Gerry O’Dell consults to medical device and pharmaceutical companies related to all the major sterilization methodologies, microbiology, environmental control, laboratory compliance, failure investigation, etc. Her varied background includes extensive knowledge in sterilization technology, laboratory management, microbiological testing (including pyrogens), decontamination of returned goods, and compliance.

Prior to starting Gerry O’Dell Consulting, she worked for Johnson & Johnson Medical, Inc. as the Manager of Laboratory & Sterilization Services which managed the sterilization program for J&J Medical in addition to providing laboratory testing services to several J&J companies. Before becoming a part of Johnson & Johnson Medical, Gerry was Manager of Sterilization Services at Critikon, Inc where she started as a Lab Technician. She holds both a Bachelor and Master of Science degree in Microbiology from the University of South Florida and has over twenty-five years of experience in the medical device industry.

Gerry is a member of the Association for the Advancement of Medical Instrumentation (AAMI) and actively participates in the Sterilization Standards Committee activities. She is currently Co-Chair of the AAMI Industrial Ethylene Oxide Sterilization Working Group and a member of the U.S. Sub-TAG for ISO/TC 198/WG 1. She is also a member of the Sterilization Residuals, Radiation Sterilization, Sterility Assurance Level (SAL), Compatibility of Materials Subject to Sterilization, and Microbiological Methods Working Groups; actively participating in the development of several standards and guidance documents. Gerry is a Registered Microbiologist with the National Registry of Microbiologists in the area of Consumer Products & Quality Assurance. She is also a member of the American Society for Microbiology (ASM), American Society for Testing & Materials (ASTM), and PDA.