Cleanliness of Product & Service and Contamination Control

[rdesmond]

Section 7.5.1.2.1 - I need help to determine if this applies to us. We are a contract manufacturer - do not produce finished medical device. Our customer also contracts for sterilization. We do not clean product prior to shipment. I do not believe it is cleaned at sterilizer before the EtO process, however do not know for sure. We rinse product in-process with Ethanol to remove plasticizers that bake out during thermal processing - this is solely for the purpose of adhesion of the ink that we apply. Failure is readily apparent. Also, we use gloves and minimize product handling, we have a pseudo-clean room - gowns, hair nets - not customer requirement - just our experience for better results of fewer fibers, etc. We do a quarterly bio-burden, environmental monitoring testing and that always looks good. So, if I am reading this section correctly, it would not apply. Thanks everyone!!

[pkost]

It is the responsibility of your customer (i.e. manufacturer in the eyes of 93/42/eec) to tell you what level of cleanliness is required of product you send them. If it isn't specified then you cannot be held responsible for it!

As a matter of courtesy though, I would point out to the customer that you do not validate any cleaning process so that they do not make a false assumption

[somashekar]

So, if I am reading this section correctly, it would not apply. Thanks everyone!!

If I am reading you correctly, it applies.

We rinse product in-process with Ethanol to remove plasticizers that bake out during thermal processing - this is solely for the purpose of adhesion of the ink that we apply

Does this not look to fall within the d) of 7.5.1.2.1
process agents are to be removed from product during manufacture.
First you do something to remove the plasticizers and then you bake to remove that something, or is baked out during an other process. (correct me if I am wrong)
It is as simple as just establishing a documented requirements for cleanliness of product, and as it further goes, validation of that activity.

[rdesmond]

In Reply to Parent Post by somashekar

If I am reading you correctly, it applies.

Does this not look to fall within the d) of 7.5.1.2.1
process agents are to be removed from product during manufacture.
First you do something to remove the plasticizers and then you bake to remove that something, or is baked out during an other process. (correct me if I am wrong)
It is as simple as just establishing a documented requirements for cleanliness of product, and as it further goes, validation of that activity.

Therein lies the question. It would be an enormous undertaking to validate this process individually. We have been producing acceptable product on this line to stringent customer requirements for over 3 years - not a single complaint, reject following shipment. I am hoping to argue that the plasticizer is a by-product, not a process agent per se. The baking is to cure the ink - the plasticizers are inherent in the PVC. There is no customer cleaning requirement. It is, however necessary to ensure ink adhesion to do the Ethanol rinse to remove said plasticizers or ink can delaminate. Following the 2nd bake, final ink cure, there is no further rinse also. Thanks.

[somashekar]

We have been producing acceptable product on this line to stringent customer requirements for over 3 years - not a single complaint,

What is this stringent customer requirement as far as cleanliness of the product is concerned.

I am hoping to argue that the plasticizer is a by-product, not a process agent per se.

Is it not a process reagent for achieving the desired flexibility of the part and that this needs a cleaning as you detail ? And again you have to clean off the Ethanol also ??

not a single complaint, reject following shipment

Excellent, you seem to have a validated process by some good means and so bring this process within guidelines of what validation means and this will help you to identify what changes if any that comes in your way will need a revalidation, so that the end result is consistently met. I do not feel it would be a enormous undertaking to validate this process.

There is no customer cleaning requirement.

It is not necessary that customer specifies this requirement within your process. You are also unsure of the further processes.
What if plasticizer leach out is a customer complaint ? In fact you are not cleaning off all the plasticizers. What if traces of Ethanol is reported from some finding ? It is better you take proactive steps for controlled processes and its validation and customer communication. Being ISO13485 QMS aligned, I would.

[rdesmond]

In Reply to Parent Post by somashekar

If I am reading you correctly, it applies.

Does this not look to fall within the d) of 7.5.1.2.1
process agents are to be removed from product during manufacture.
First you do something to remove the plasticizers and then you bake to remove that something, or is baked out during an other process. (correct me if I am wrong)
It is as simple as just establishing a documented requirements for cleanliness of product, and as it further goes, validation of that activity.

Thanks for the detailed feedback!! Sorry if I was not clear on some points. There are no cleaning requirements of any kind. The stringent req'ts to which I referred related to product performance and aesthetics. We do not clean off Ethanol - it air dries so indeed would be expected to leave some remnant. This however would flash off during baking - 130C. We have fully process validated this product & re-validate with any changes.

So, again related only to the ISO 13485 req't - can section 7.5.1.2.1 be noted as not applicable? Thanks again!!

[theGrod]

I don't have an answer but a related question if anyone can help. We are a very small class 1 device manufacturer and need to venture into the decontamination process for product returned after trials. How does one set up a decon area and process? Also, what is the FDA requirement that discusses this topic?

Thanks