Biological Indicators for Sterilization Performance Qualification

Why Should You Attend:

A successful Performance Qualification for sterilization processes consists of both physical and microbiological verification. While the physical verification demonstrates sterilization parameters are achieved, the microbiological verification provides empirical evidence of a successful sterilization process. The focus of this webinar is to describe biological indicator usage for sterilization Performance Qualification in the pharmaceutical and biotech industry.

An overview of bacterial endospore science and modeling inactivation of spores is covered. The process and key terminology are defined. Biological indicator preparation, including population and D-value resistance determination, is presented in depth. Understanding these details is critical to successfully choose a biological indicator and qualify a sterilization process.

Using biological indicators is an essential part of sterilization Performance Qualification. An overview of different sterilization mechanisms, along with the appropriate indicator organisms, is given. Regulatory references requiring use of biological indicators are provided, along with definitions for sterility assurance level, accumulated lethality, temperature mapping and biological verification.

Common questions and hot topics in industry are presented to demonstrate the practical application of understanding biological indicators. These points exemplify how the knowledge allows for efficient troubleshooting of unexpected events and for improving sterilization processes.

Areas Covered in the Webinar:

• Endospore science
• Biological indicator preparation
• Modeling of bacterial spores
• D-value and population determination
• Use of biological indicators in sterilization performance qualification
• Regulatory and GMP expectations for use of biological indicators

Who Will Benefit:

The following professionals from all FDA regulated industries will benefit from this training:

• Quality Assurance
• Microbiologist
• Operations
• Production
• Validation

Instructor Profile:

Aaron Mertens has been a member of the STERIS Life Sciences Formulated Chemistries Technical Service Group as a Technical Service Specialist since January 2015. In this role, Aaron has responsibility for providing global technical support primarily for Critical Environments and Sterility Assurance and Barrier Products, application and validation.

Previously, for 7 years Aaron was the US Technical Manager for Atec Sterile Technology USA, a partner of Atec Pharmatechnik, Germany. For Atec USA, he was responsible for providing technical support for new and existing sterilization systems. This included project management, equipment commissioning, qualification, maintenance and troubleshooting. Also, while at Atec, Aaron managed the Commissioning and Qualification Program by maintaining standards, procedures and testing methods.

Prior to that, Aaron spent nearly 10 years at Pfizer in Kalamazoo, MI. At Pfizer, he specialized in sterilization validation of autoclaves, dry heat ovens / tunnels, freeze dryers and stopper processors. Additionally, he gained experience interfacing with industry regulatory agencies (FDA, EMEA, Japan), representing validation programs for steam, dry heat, vapor phase hydrogen peroxide and irradiation sterilization processes.

Aaron has been a member of ISPE and PDA since 1999, contributing by presenting posters and talks at meetings, as well as participating in local chapter functions. He holds a bachelor’s degree in Genetics from the University of Wisconsin – Madison.

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