PVC Tubing Extrusion - Class I medical device

G

gereard_kgb

#1
Hi Everyone,

We are just launching a factory of medical devices. One of the products is medical tubing (no contact with patient)- class I medical device according to MDD.

Can anyone share their experiance with this product?
Does it have to be manufactured in the clean-room?
How about the extrusion process itself? This is made of PVC, what temperature should be used for extrusion?

Thanks in advance for any comments.

Bye,
Gereard!

:thanks:
 
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R

Rob Udo

#2
Environmental requirments regarding the manufacturing location depends on the intended use of the device and the associated risks. You have to comply with the essential requirements from the MDD! If you can comply with these requirements without a clean-room environment, it is fine.

Regards,
Rob
 
G

gereard_kgb

#3
Thank you Rob.

I fully agree with your comments. EN550 also points out that intended use is very important as far as sterilization and manufacuring conditions are concerned.

Yet there is one more issue raised by EN550 - being bio-burden. Its control plays some role in sterilization.
The point is we talked to a few auditors and each had different point of view.

The intended use for this product is such that it could be in full manufactured and assambled out of the clean-room.
My main concern now is sterilization. I think it should be validated for a certain bio-burden (no matter low or big). In case a product is manufactured out of the controlled cleanness zones there is nothing you can say about the bio-burned, right?
In this case what sterilization process is appropriate?
Is there a EO sterilization process long enough that it can be assumed all the products were sterilized no matter what the bio-burden was?
Is there an EN norm for this? (I don't know any)

Any hint is welcome.
 
G

Gert Sorensen

#4
Does it have to be manufactured in the clean-room?
No. If it is non-invasive, and it does not get in contact with invasive parts, then it does not need to be.

How about the extrusion process itself? This is made of PVC, what temperature should be used for extrusion?
I will highly recommend that you test this yourselves. Calibration, maintenance, the extruder you are using, the humidity of your compound etc. will have an impact. Depending on the tolerances you may have a "walk in the park" production or a nightmare when you extrude PVC. Only you will be able securely establish your process parameters.

Bio-burden. Its control plays some role in sterilization.
Yes it does, but basically you only need to consider bio-burden for invasive devices - in my experience.

The point is we talked to a few auditors and each had different point of view.
Well, small wonder! :notme:

The intended use for this product is such that it could be in full manufactured and assambled out of the clean-room.
My main concern now is sterilization. I think it should be validated for a certain bio-burden (no matter low or big).
Now, you lost me here. If the product can be assembled and manufactured in a non-controlled zone, then why does it need to be sterilized. Could you elaborate a bit?

In this case what sterilization process is appropriate?
Usually, when sterilizing you use an incubation of 2 million. This should be - more or less - easily sterilized in an EtO sterilization (depending on productdesign).

Is there a EO sterilization process long enough that it can be assumed all the products were sterilized no matter what the bio-burden was?
It is just like foods. You can "nuke" your product from here to kingdom come, it still may not be safe :confused: Some bacteria create poisonous substances when they die. This won't be solved by sterilization. And this is one of the reasons that bio-burden is interesting. However, if the product is non-invasive I believe that the usual interpretation is that you have nothing to worry about.
:bigwave:
 
G

gereard_kgb

#5
Gert,
Thank you very much for your detailed answer.
As far as the extrusion itself is concerned we are making some progress and exactly as you said - the experimental method is the one :)

The product we are to manufacture are connecting tubes - product that has no contact with the patient. Yet for some customers it needs to be delivered sterile (and most of the manufacturers have the tubes available as both sterile and non-sterile) so we need to be able to have it certified by a notified body (the goods need to be CE marked of course).

I fully agree that bio-burden itself needs to be carefully controlled for all the invasive products as their pyrogenity is of serious concern.

However were said that that bio-burden needs to be controlled so that it could be said that the sterilization process can be properly validated.
That's why I was wondering if there is any process long enough that could give acceptable certainty that no matter what bacteria were there they are all dead (of course not gone - but for this particular product it doesn't matter).

Is there any standard to support the discussed issues?

:rolleyes:
 
G

Gert Sorensen

#6
I think you are looking for:

ISO 14937:2000 - Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
 

chris1price

Trusted Information Resource
#7
Hi

I don't think there is a sterilisation process long enough to guarantee sterilising all materials, irrespective of the bioburden. For Gamma, VDMax25 methods are suitable for bioburden upto 1000CFU, beyond this, more intensive validation methods are required. For EtO, knowledge of the bioburden is critical to establishing the exposure, if the bioburden can vary, then sterility cannot be guaranteed. Extremely long EtO cycles may look attractive, however they also result in long aeration times and difficulties in removing the Eto Residuals.

One further comment, for this type of application, cleanrooms are used to control contamination by dust and hair on the product more than bioburden.
 
Q

Quality Priest

#8
We have several product using silicone tubing.
The tubing is supplied to us in a `clean` state, But the tubing is very rarely in a state that we would class as acceptable for sterilization.
As you can well appreciate form your extrusion process the product has a tactile nature, we routinely send away samples for Bioburden prior to manufacture to find the counts (1000cfu +) to high to guarantee sterility at Gamma Irradiation dose of 25kGy.

I have done allot of work with the stability of the post irradiated silicone tubing including elasticity, memory also dosing at 50+ kGy (not recommended). Silicone tubing has probably been the hardest product to justify to our regulatory authority.

As Chris has mentioned about the cleanroom if you can justify that the product will be contaminant free with out the use of a cleanroom (thinking also visually to you customer) then you are only looking at reducing your bioburden to limits of below 1000cfu
 

chris1price

Trusted Information Resource
#9
I'm surprised your bioburden on silicone tube is that high, I would be looking at ways of reducing it. When extruded it should be essentially sterile, from then on it's getting contaminated. If its kept clean and not handled too much, the bioburden should stay low. I would also suggest a wash with 50/50 IPA/water before its pouched will remove most bioburden.
 
G

gereard_kgb

#10
Chris1price, what is IPA?

I agree to what Quality Priest said about the use of clean-room. If it could be justified that the product can be manufactured outside of it with low contamination. Yet how can it be justified that the product is contamination and dust free when it is manufactured out of the clean-room? What are the other zones of controlled cleanness? what are the applicable norms?

I share the opinion of Chris1price that the product coming out of the extruding machine is almost sterile. There is only an issue what happens next and how the product is dealt with.

What do you think about washing the product with alcohol? This should reduce bioburden quite much.
 
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