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The ARPM Rubber Manufacturing Blog allows members to rapidly communicate with each other. Post both questions and answers to questions that other ARPM members have about any industry topic from material and process issues to R&E Tax Credits and other business issues.

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Rubber Manufacturing Blog / Business / Process Validation (IQ, OQ, PQ)
Posted:  01 Jan 2014 15:30
A customer of ours has asked us to do a formal "Process Validation" for our molding procedures related to their parts.
Does anyone have a completed "process validation" that they would be willing to share so that we don't have to re-invent the wheel?
At its core, this does not seem too complicated, but the lingo and acronyms make starting the process a bit daunting.

Charlie Braun
Posted:  02 Jan 2014 14:02
I was not clear above.  The customer in question is a medical device customer and the "Process Validation" that we need to complete is outlined in ISO13485 and FDA QSR 820.75.
We don't have copies of either of these documents and may end up buying them if no one has anything that might help us cut to the chase.

Charlie Braun
Posted:  08 Jan 2014 22:34

The ISO13485 standard and the FDAQSR820.75 (type in google and standard appears on FDA website….available free) are required guidelines that you may need to satisfy.  Your Process Validation procedure must address and meet the requirements detailed in the 13485 standard and FDA Code 820.75.

FDA QSR820.75 = ...

ISO 13485 Standard = :L:d&filter=0&site=knowledgecenter&source=bs&kind=books&q=13485+inmeta:dDocType=Books&dnavs=inmeta:dDocType=Books" target="_new" rel="nofollow"> ...

The FDA QSR is no charge and on the FDA website at above link.  The 13485 Standard is available for purchase at the above link….this is where Polymer Convesions purchases their Standards.  Basically, your Process Validation will need to meet all elements of the standards.  You may look into training courses like those offered at Penn State - Process Validation For Medical Molding Courses at Penn State ( )

This information was communicated by Ben Harp of Polymer Conversions.  He has offered his Director of Quality, Karen Klemmer, for more insight.

Ben Harp
5732 Big Tree Road
Orchard Park, NY 14127-4196
P: (716) 662-8550   F: (716) 662-8555
email:  (bharp(at)

Let me know if you need any addtional information.

Troy Nix
Posted:  09 Jan 2014 01:48   Last Edited By: ARPM
Charlie, I talked with a medical device manufacturing executive and found a resource they use extensively for process validation requirements like the one you have recevied from your customer.  The indivdual has a strong product development background with very extensive expertise in Process Validation documentation gaining a great deal of experience from Boston Scientific.  Contact information:

Jeff Zerfas
Phone:  812-345-9946

Troy Nix