Steam Sterilization Microbiology and Autoclave Performance Qualification
Date : 26 February 2019
Time : 01 : 00 PM EST
Duration : 60 Minutes
Danielle DeLucy, MS, is the owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance. Prior to this role, Danielle has been in the industry for 15 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations. Danielle began her QA career as a Quality Control Pharmaceutical Microbiologist at a contract laboratory where she performed various tests for their clients. In the years after, she has held positions in the Quality management arena while increasing her responsibility. She has helped to lead many Regulatory Health Inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, Danielle assists companies who are faced with warning letters, consent decrees and those wishing to improve compliance establish more robust quality systems so that the company can succeed.
Successful autoclave Performance Qualification starts with a fundamental understanding of steam sterilization microbiology. In this webinar, the steam sterilization mechanism will be described as it relates to bacterial cells and endospores. The process and key terminology are defined. Understanding these fundamentals is critical to developing a successful autoclave sterilization process.
Sterilization process parameters will be laid out as a basis for conducting autoclave performance qualification studies. Whether qualifying a new autoclave installation or continuing maintenance of existing equipment, there are specific expectations for steam sterilization that must be met.
Regulatory references requiring the use of air removal verification tools, chemical indicators, and biological indicators will be provided, along with definitions for sterility assurance level, accumulated lethality, temperature mapping, and biological verification.
Common questions and hot topics in the industry will be presented to demonstrate the practical application of understanding steam sterilization. These points exemplify how the knowledge allows for efficient troubleshooting of unexpected events and for improving processes in an autoclave.
- Steam sterilization on a microbial level
- Autoclave Performance Qualification expectations
- Regulatory and GMP requirements for steam sterilization
- Process verification tools for use in an autoclave
- Common questions, problems, and cGMPs
- IQ/OQ/PQ Requirements for Autoclave Validation
- Autoclave Monitoring Tests
- Biological Indicators - How and When to Use
- Verification vs. Revalidation
Who Should Attend
Quality Assurance Managers, Supervisors, Validation personnel, Sterility Assurance personnel.
- Speaker: DANIELLE DELUCY
- Webinar Code: DANI-0017