Autoclave Validation

1. Autoclave Validation Presented by Paul Yeatman, Microbiologist No additional slide notesNo additional slide notes

2. Introduction Introduce self. What’s in it for you? If we did not have autoclaves (or steam in place), life would be different for the pharmaceutical industry. Sterilisation would involve fire (or heat), chemicals, filtration or radiation. Microbiological media would have a shorter shelf life and there would be a greater risk of contamination. Autoclave means “auto lock”. Interesting info: The man credited with initiating the project which lead to the invention of the autoclave was Charles Chamberland. He worked with Louis Pasteur and also invented a vaccine for chicken cholera by accident. 5mins Who am I? What is my industry experience? 9 yrs sterile injectable manufacturing, environmental monitoring 2 yrs control of media fill program has performed autoclave and incubator qualification/validation 5 years non sterile manufacture ~15 yrs general microbiology including 6 yrs in supervisory roles WIIFy? If you have no or minimal knowledge of the autoclave, this presentation will be of benefit. If you have never audited an autoclave, you will have an idea of what to look for if/when you do. 5mins Who am I? What is my industry experience? 9 yrs sterile injectable manufacturing, environmental monitoring 2 yrs control of media fill program has performed autoclave and incubator qualification/validation 5 years non sterile manufacture ~15 yrs general microbiology including 6 yrs in supervisory roles WIIFy? If you have no or minimal knowledge of the autoclave, this presentation will be of benefit. If you have never audited an autoclave, you will have an idea of what to look for if/when you do.

3. Presentation Aims/Outcomes What is an autoclave Why we use autoclaves Identify the two main types used by us Detail how to validate an autoclave (including loading patterns) What to look for in an audit No additional slide notes: 1minNo additional slide notes: 1min

4. What is an Autoclave? How do they work In general In order to sterilize Types common to us Why use an autoclave What may affect sterilization Steam penetration No additional slide notes: 1minNo additional slide notes: 1min

5. Hows Does An Autoclave Work? Steam enters the chamber jacket, passes through an operating valve and enters the rear of the chamber behind a baffle plate. It flows forward and down through the chamber and the load, exiting at the front bottom. A pressure regulator maintains jacket and chamber pressure at a minimum of 15 psi, the pressure required for steam to reach 121ºC (250ºF). Overpressure protection is provided by a safety valve.