Raw Materials verification - Melt Flow Test - Resins: Customer not Satisfied

C

Carl Keller

#1
Ran into an interesting one recently.

A customer audited and was concerned because we completed a melt flow test on every 5th lot of resin. They felt we did not have a satisfactory raw materials verification procedure.

They will probably really be upset now because since then, I have completely eliminated melt folw testing for the following reasons:

1. We have never received a melt flow outside the stated range and hence, have never rejected a lot of resin for melt flow.
2. Melt flow for different resins can be within the same range, so what is it telling you?
3. We use major resin suppliers which provide resin certs and state the resin, lot number and melt flow.

So my question is, what would the FDA think? AND how do others verify that what is in the box is the same as what is stated on the incoming cert. because melt flow is definitely not conclusive.

Carl-
 
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Al Rosen

Staff member
Super Moderator
#2
The FDA has no specific requirement and leaves it to you to determine what is required to accept incoming product. But depending on the application you would need more or less stringent controls. You didn't state what the material is being used for. Will it be in contact with the body? Will it be used in an implant? This could affect how the FDA views acceptiong the material based on a suppliers cert.

To assuage your customer's concerns you could periodically (annually or a some reasonable period) send a sample of the material to an independent lab for analysis to verify your supplier's certification.
 
C

Carl Keller

#3
Al,

Thanks for the insight.

Materials are used for Pharma packaging and one medical device that is not an implant (dosage delivery)

Resin analysis is very costly and I would like to avoid even annual checking.

I am not sure the credentials of the lab would be any better than our resin suppliers anyway. We deal with the major players for the most part.

Thanks,

Carl-
 
V

Vincnet

#4
Well Carl,

in my opinion the whole story revolves around the risk analysis for the use of the resin in the final product. In other words what are the essential properties of the resin you need to control to ensure that your final product will not be affected by modification of these properties in one batch.

I have to deal with this nightmare every single day. :bonk:

My R&D dept and my manufacturing dept are not abble to tell me what are the essential specifications of the raw material we need to monitor to make sure that the final properties of our products are not altered. :whip:

The way I found to go round that, is that we do not consider a raw material as being OK until it has been used for manufacturing a product that passed the final functional QC before release. The assumption being there that if the final product is ok then the raw material is. The economic issue being if the QC is not good then we have to track back which component is not ok.
I did not felt completely confortable with that i reccently met with a company specialised in process validation. Those guys told me that in our field (Biotech) it is becomming more and more common to do so.
We have a 13485 pre audit on the 21st of this month, I'll let you know if my auditor killed me :mad: or not :agree1:

V
 
C

Carl Keller

#5
Vincent,

Thanks.

We are 13485 registered, but the auditor has not taken issue as yet. The customer did an audit "based on FDA regulations".

I think I am on pretty solid ground with my thinking.

We get a Cert from the Manufacturer
I can show evidence of past history
We use SPC for dimensional stability
We have final QC checks for dimensional measurements

Good luck on your audit.

Carl-
 
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