Clean Line Validation

QE1993

Involved In Discussions
#1
Hello,

Would you consider a difference between a clean line and a wash line? I was always under the impression that final clean was a special process that required a validation, using ISO 14971 as guidance. Our company has a "clean line" but it's more of a wash/degreaser kind of situation, IMO. We do not claim to perform final clean for any of our customers nor do they require it. We are merely getting crap from our shop floor off before we ship to our customer (who is not the end user and they are responsible for performing any kind of final clean). We have a validation on file that partially follows the ISO guideline but is mostly concentrated on ensuring the contact materials from our floor are removed, so we are not doing things like the bioburden test.

Our sister company was auditing us and said this was unacceptable and our cleaning validation should follow ISO 14971 completely. There's just no way we would pass some of those tests, because again, I don't believe we are set up as a clean line.

Does anyone have any insight into this?
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Our sister company was auditing us and said this was unacceptable and our cleaning validation should follow ISO 14971 completely. There's just no way we would pass some of those tests, because again, I don't believe we are set up as a clean line.
I see some conceptual confusion here.
a) ISO 14971 is most appropriate for finished devices. What you make and supply are components for further processing, so...
b) ISO 14971 doesn't prescribe any tests - "those tests"...???
c) Bioburden testing is only relevant where allowable viable matter contamination level is prescribed somewhere or otherwise relevant (e.g. in the lead up to sterilization) - doesn't sound like your case.
d) The connection between cleaning validation and ISO 14971 is quite loose, and definitely not obvious. I understand doing a risk analysis as the first step in any validation, but why ISO 14971?...
e) The purpose of a cleaning validation is to establish high confidence (I don't dare say certainty) that the parts produced will consistently meet the cleanliness requirement. This is instead of checking (verifying) each and every single part that comes out of the process (impractical). If you have done that with enough rigour (physical/scientific and statistical), you are done! Perhaps worth checking if there's a published technical standard specific to this type of product (part) or process (either the manufacturing or the cleaning) and following it - another layer of assurance.
f) I think that the distinction between "clean line" and "wash/degrease line" is unnecessary and doesn't add clarity. What matters is what is being cleaned, what the required result cleanliness is (is it specified?), and what the actual process involves.

maybe I should stop here... there's enough food for thought above.
 

Tidge

Trusted Information Resource
#3
I have personally witnessed confusion between cleaning, line clearance, and (weirdly, IMO) non-conformance handling during regular processing. This issue reads to me like yet another variant of the confusion I have encountered.

If the part(s) being machined are not finished goods, then QE1993's shop floor is almost certainly not performing 'cleaning' in the sense of addressing a finished good. I will have a later caveat on this point. It is very likely that the sister company has sublimated the adage that "cleaning" (like sterilization) is a process that "can never be verified, only validated." The sister company was likely 'triggered' by the shop floor's use of the word 'cleaning', but the only part of the story that appears obvious right now is that the expectations of both parties is disjoint.

The first thing that should be done is to firmly establish the specifications for the manufactured part to be supplied to the sister company. It could be the case that the receiver of the machined parts has expectations for 'cleanliness' that were not communicated and were expecting to pass onto the supplier. Some expectations are not always realistic. For example: it is not common that molded plastic parts are completely free of mold release agents when received at a finished goods manufacturer, nor would a piece of glass be completely free of dust. In any case, the specifications have to be established, and then appropriate control plans (at the manufacturer) are put in place to describe how the supplier will meet the needs of the purchaser. Control plans don't need to be restrictive, they can be as simple as having a router that lists the processes the part passes through (e.g. cut, punch, deburr, wash). Note that 'floor sweeping' is not part of the process of making machined parts (unless you are making parts from the floor sweepings!)

The promised caveat: There are some medical devices (generally implantables) with machined/molded parts for which inferior cleaning of components has been identified as the root cause of a large number of very serious medical complications. This could be one cause of sensitivity by the sister company. It is the responsibility of the manufacturer (of the finished device) to guarantee the safety of their devices... my guess is this is the way 14971 has entered the discussion. It is possible that the sister company's medical devices require a certain level of cleanliness but does not have processes (and risk controls) in place to guarantee the required 'cleanliness' of certain parts and is trying to pass that burden to QE1993's company.
 

QE1993

Involved In Discussions
#5
Thank you for this post. This has cleared some things up for me.

1. We DO make implants (contract manufactured - we do not D&D); however, the burden of "final clean" was never required by our customer. They do their own sterilization/final clean.

2. I think there is a confusion between our use of the word "clean line." What we really do is an in-process clean of the implants, covered in ISO 19227. Before I came on board, they chose to add Total Organic Carbon and Cytotoxicity tests for the validation, which were the only two tests one customer requested along with validation that our contact materials are being removed (degreasers, coolants, etc.).

3. Our sister company wants us to deploy all the tests listed in ISO 19227 - my fear of doing this is that we will NOT pass some of the tests (bioburden tests), because we are not set up as a controlled clean line - we are simply attempting to remove contact materials from our parts (which is also part of the validation). We added TOC and Cytotoxicity at the request of a customer, but they have not asked for any other tests or asked for us to conform to ISO 19227 and neither has any other customer.

4. The confusion is what responsibility do contract manufacturer's have in ensuring the cleanliness of implantable devices? We go as far as to ensure that our contact materials have been removed and none of our OEM customers have asked for any kind of final clean, so I"m not sure were we are going wrong. Before i go to our sister company, i'd like to gather as much information as I can because this is a pretty confusing topic.
 

Ronen E

Problem Solver
Staff member
Moderator
#6
:topic:
[Wearing the injection molding veteran hat]
it is not common that molded plastic parts are completely free of mold release agents when received at a finished goods manufacturer
That's true only if you work with poor suppliers, part design or tool design. Appropriately designed parts and tools don't call for the use of any mold release agents (except for MAYBE at the very beginning of the molding run, the output of which should be automatically scrapped anyway), so there would be no reason to use such agents and no reason why the molded plastic parts would not be completely free of mold release agents when received. Even with less-than-perfectly designed parts and tools, mold release is not an absolute necessity, and in many cases molder expertise would suffice to address any ejection difficulties. Typically, the use of mold release agents is testimony of lack of molding acumen, unless the part or the tool are grossly sloppily-designed.
 

Ronen E

Problem Solver
Staff member
Moderator
#7
4. The confusion is what responsibility do contract manufacturer's have in ensuring the cleanliness of implantable devices? We go as far as to ensure that our contact materials have been removed and none of our OEM customers have asked for any kind of final clean, so I"m not sure were we are going wrong. Before i go to our sister company, i'd like to gather as much information as I can because this is a pretty confusing topic.
In this context, although you "manufacture under contract", you should be more careful when using the term Contract Manufacturer (CM), which has a regulatory meaning (more or less well defined in the various regulatory domains). In medical devices regulatory terminology (at least FDA-related), CMs manufacture finished, or near-finished devices that are essentially ready for sale and use, with some exceptions like sterilisation etc. From your description I conclude that your company is NOT acting as a CM; you are merely a component supplier.

When you ask "were we are going wrong", you may (better) ask "what established requirements are we not meeting". Unstated or un-agreed expectations, desires, wants, dreams etc. are not the same as established requirements. Second, note the difference between applicable regulatory/statutory requirements (that are mandatory and apply even if you're not aware of them and haven't explicitly "accepted" them), and customer requirements, which are a matter of commercial viability. To briefly summarise - I think that there is no regulatory (mandatory) requirements for cleaning (let alone cleaning validation) that applies to component suppliers (who are not CMs), and it seems like you are meeting your customers established (and accepted) requirements. So - you are not going wrong, apparently. Whether you can do better / excel / delight your customers ("Wow factor") is a different matter, which belongs in the OFI (opportunities for improvement) category.
 
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