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Successful autoclave Performance Qualification starts with a fundamental understanding of steam sterilization microbiology. In this session, expert speaker Danielle DeLucy will describe the steam sterilization mechanism as it relates to endospores and bacterial cells. The process and key terminology are defined. Understanding these fundamentals is critical to develop a successful autoclave sterilization process.

Objectives of the Presentation

• 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

Why should you Attend
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 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 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.

Areas Covered

• Definitions
• IQ/OQ/PQ Requirements for Autoclave Validation
• Autoclave Monitoring Tests
• Biological Indicators – How and When to Use
• Verification vs. Revalidation

Who will Benefit

• Quality Assurance Managers
• Supervisors
• Validation personnel
• Sterility Assurance personnel

Instructor Profile:

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People are the biggest source of contamination in cleanrooms. The findings from the human microbiome project suggest an overview of controls is required. This presentation reviews the latest research into the human microbiome, especially in relation to the skin, and looks at the levels of controls and risks required, such as behaviors and gowning practices. The presentation also considers the impact of the knowledge on the use of environmental isolates for culture media testing and applied areas like disinfectant efficacy testing.

Objectives of the Presentation

• To understand the latest research on the human microbiome
• To learn about the reasons for microbial survival in people and in cleanrooms
• To understand the types and ranges of microorganisms on human skin, and how these relate to objectionable organisms
• Review staff gowning and personnel behavior in pharmaceutical cleanrooms
• Consider good glove sanitization practices
• Learn how cleanroom risk can be minimized
• Review training for all cleanroom staff
• Look at the use of environmental isolates for media and disinfectant efficacy testing

• Engineers
• Lecturers
• Production managers
• Microbiologists
• Quality Assurance
• Production staff
• Maintenance / engineer staff
• Medical staff
• Pharmaceuticals – sterile and non-sterile
• Biotechnology
• Healthcare
• Academia

Instructor Profile: