Process Validation - Fabric Medical Device


I’m new to both the engineering and validation field and am starting my first validation with little background knowledge about validations. My company is going to begin production of medical devices - fabric wraps - that pose little risk to consumers but need to be validated nonetheless. I have been tasked with setting up a validation master plan and writing protocols, and would greatly appreciate a little guidance. Everyone in the facility is new to this type of work, so my internal guidance is not necessarily far-sighted.

The process - without being too descriptive - entails some sheeting of rolled material, die cutting, screen printing, plastic welding, sewing, and heat sealing a bag. I am told that all of these process steps will require an IQ. Is this true, even if variation from some of the simple steps (sheeting, heat sealing for instance) cannot produce any foreseeable negative impact on the final product?

I’m sure additional questions will follow. I am very appreciative of any input.


Hi Justin,

There is alot going on there in your question, so I’m not sure where to even begin.

First of all do you know what the Master Validation Plan should contain?


Hello Graham,
If we get some more details Iam sure we could help him.

Yes indeed, we will give good guidance.

[quote=DURGA PRASAD]Hello Graham,
If we get some more details Iam sure we could help him.

Hi all, sorry about the absence. I’m just getting back to work after the holiday.

Graham- as far as what the master validation plan should contain, I believe I understand that. It should define the validation tasks for the entire process, and include (roughly) the following topics:

version history
related documents

responsibilities of all parties
plant/process/product description
list of products/process/systems to be validated
key acceptance criteria

So, now that I think I have an idea of what the document I need to create must contain, I have some questions about what validations need to be performed, and I’ll start at the beginning. the process starts with sheeting several types of fabric out from rolled form into rectangles. The rectangles are then layered and die cut into different shapes, and each shape has a length and width specification. Since the sheeting does not necessarily affect the product quality and there is a very low risk of sheeting operations affecting product quality, does validation work need to be done here? If so, would an IQ suffice?

Thanks, I appreciate any and all input.