Autoclave validation is a daunting and time consuming task. It is also critical to ensuring compliance to FDA GMP guidelines, being an area of high risk to pharmaceutical product quality.
This new white paper provides practical, hands-on advice about autoclave validation. Describing the top ten considerations when validating a vacuum assisted steam sterilisation unit, the white paper discusses issues such as:
- choosing the right sterilisation cycle
- how to determine the loaded heat distribution for autoclave validation
- how to choose the right liquid Control for validation runs
It also lists guidelines for scheduling the different tasks of the validation project.
Making the wrong decisions during an autoclave validation project can have serious implications. It can cost you days or even weeks of lost time. Worse, you can compromise product quality or fail a regulatory audit. It's worth knowing the pitfalls and how to avoid them.
You can do this yourself or contract this service to us on an hourly basis or fixed price.
You can download this white paper for free.
Download white paper (no registration required)