Steam Sterilization Microbiology and Autoclave Performance Qualification

Why Should You Attend:

Successful autoclave Performance Qualification starts with a fundamental understanding of steam sterilization microbiology.

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.

Learning Objectives:

• 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

Areas Covered in the Webinar:

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

Frequently Asked Questions:

1. For sealed container moist heat sterilization, how much water is too little/too much?
2. Regarding cycle development, not sure if I can ask about BS EN 285 here but there is a specific criteria that says the equilibrium time must be within 30 seconds, any way to troubleshoot the autoclave performance to meet this criteria?
3. Common cycles, 121 for 15 min or 134 for 3 minutes - any risk regarding each of these concerning steam quality? any reason one would choose 121 deg over 134 deg other than the capability of the utility? any difference in cycle development here?
4. Regarding moist heat sterilization, is there any reason one would choose 121 deg C for 15 minutes over 134 deg for 3 minutes?
5. Would you have to repeat a temperature mapping load study if the number of items are identical but configuration is different? For example, if we qualify a cycle with 600 vials top/bottom but then we have a new configuration where it is 200 top/middle/bottom, do we have to perform temperature studies again or an equal based off master solution will do?
6. Do you have comments for continuous process sterilizer compared to batch process?
7. How are the regulations for Nutraceutical Industry compared to Pharma?
8. If dry heat is the main agent against pyrogens, do pyrogens remain after moist heat sterilization? And if so, would there need to be additional processing for say filling equipment to be rid of pyrogens?
9. For BI ampoules, why can they only be used in liquid loads?

Who Will Benefit:

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

Danielle DeLucy
Owner, ASA Training and Consulting, LLC

Danielle DeLucy, MS, is 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.

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