Hello all.
I have an issue and would appreciate everyone’s experience and suggestions. It would seem like a common issue at companies and there must already be established ways to handle it.
I have a number of fixed-load, fixed-position configurations for our autoclave. Recently I underwent a long exercise to create a variable-load, variable position configuration (one min and one [very] max load with detailed list of components). Though I had to run a lot of extra runs up-front during the study and validation, the reason to undertake the exercise was to give maximum flexibility to production. It works beautifully, giving production the ability to push replacement or extra components.
The issue: how should I handle random components into the clean room? These would be items we cannot anticipate, such as some random broken steel or stainless machine repair parts, screws/nuts/bolts, tools, a one-up piece, etc and do not want to waste so many resources into validating a fixed or variable load for them (also very difficult). These are things that do not touch product but have to be sterile to be allowed into the cleanroom. Our SOP states that only validated loads can be used. What should we do? What do others do?
I considered making a variable min/max load based on stainless steel weight, e.g. validate 250 grams mass and then 150kg of maximum surface area parts. Then, a random repair load would be weighed instead of counted. Is that acceptable, justifiable, or is there even a precedence?
Suggestions and experiences please. Reference material to refer would be appreciated.