I have had a lot of experience with sterilizers; right through, from the initial concept prior to purchase through to re-qualification studies.  I’ve seen the pitfalls, experienced the pain and pressure.  I can help you right through this process or just during part of it.

 

An area of concern in the industry is the amount of autoclave and sterilizer validation and qualification that seems to take place.  Companies are under cost pressure; one way to ease that pressure is to evaluate a risk based and cost effective approach to sterilizer validation and qualification.  I can help you as I’ve had a lot of experience in this area.

 

I also provide an independent review of validation, qualification and maintenance data, providing appropriate recommendations for improvement, both in activities, analysis, reporting and cycle development.  

 

I have reviewed and developed validation documentation (Design Qualification, User Requirement Technical Specifications, Functional Design Specifications, Factory Acceptance Testing, Site Acceptance Testing, Installation Qualification, Operational Qualification, Performance Qualification) for use in both pharmaceutical and biotechnology companies.  This has often required an ability to negotiate with, and bring on board, a number of functions (e.g. Purchasing, Engineering, Production, Microbiology, Validation as well as Quality).  Where desired by the client, I have co-ordinated Validation and Qualification activities.

 

Autoclave cycle failures.

‘Daily Air Removal’ chemical indicator test failures.

‘Equilibration time failure’.

Wet loads.

‘Superheat’.

Low temp in silicone tubing.

Long cycle times

Air Detector’ failures

‘Non-condensable gases’ - failed Steam Quality test  

‘Leak Rate’ test failures

Polypropylene containers collapsing

Biological Indicator growth problems

Door seal failures

Temperature overshoot issues

 

I look forward to hearing from you - drop me an email