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.
I beg to differ, if the cooling water for the extrusion process is not clean, then it will add significantly to the bio-burden. However, if the tubing is not invasive it may not be a problem, IMO.
Hi Gert, for thermoplastic extrusions you are right, the cooling water needs to be kept clean, but silicone extrusions are heated to high temperature to cure them, typically well over 200C.
BTW, IPA= Isopropyl Alcohol, usually mixed 50/50 or 70/30 with water. I'm told its a better disinfectant when used with water, but no one could ever tell me why!
Hi Gert, for thermoplastic extrusions you are right, the cooling water needs to be kept clean, but silicone extrusions are heated to high temperature to cure them, typically well over 200C.
BTW, IPA= Isopropyl Alcohol, usually mixed 50/50 or 70/30 with water. I'm told its a better disinfectant when used with water, but no one could ever tell me why!
If you use PVC tubing and you manufacture it in an environment that is not a clean room, consider washing the tubes in Ethyl alcohol or Iso-Propyl alcohol. This will reduce the CFU (colony forming unit)count per device significantly. If you can validate that you get a low CFU count ( up to a few hundred) every time you do this alcohol-wash, your'e sure to get by with one cycle ETO. I don't know your'e product but generaly I would not recommend using radiation as means for sterilization for PVC tubing. There are all sorts of effects resulting from polymer cross-linking, including change of color and loss of elasticity, so I would say stay with ETO.
Do you mean washing it in ultrasonic washing machine or without it?
Do you know any standard procerdures for washing medical devices? are there any norms available?
there is also one more point that botheres me - flamability of alcohol... I'm afraid it could explode or start to burn (I'm afarid it already happened - it started to burn - we used ethyl alcohol in ultrasonic machine - no causalties nor loss this time). is IPA safer?
Remember - your aim is the reduction of CFU count. In order to do this, you don't need to use an ultrasonic bath. Of course you will have to test whatever method you choose. To the best of my knowledge there are no standards to washing but rather common practices depending on the type of material used (metal, plastic, etc.) and the type of soiling affecting your product. I'd suggest start with a 20 second immersion in a 70% IPA (Iso-Propyl-Alcohol) bath. If you have lumens (secondary channels in the tube wall) make sure they are immersed too. After drying and packaging, send for CFU count testing. At the same time send for testing an untreated sample. Compare the results. Ideally, you should get a TNCT (too numerous to count) result from the untreated sample and a result of up to 200 CFU per device in the treated sample. If the result of the IPA-treated sample is larger, increase the immersion time and test again. Remember to wash your gloved hands with IPA. The same goes for every surface you put your device on. Good luck, and please keep me posted on the results.
Sorry, I can't help you here, because I don't use them. Check the Technical Data Sheets and the Material Safety Data sheets (MSDS) that can be found on the web.
Maybe you could outsource your prodcuts to Asia, we are qualified medical device supplier in Asia (approval ISO, CE), could supply medical tube to you. www.lily-medical.com
This site uses cookies to help personalise content, tailor your experience and to keep you logged in if you register.
By continuing to use this site, you are consenting to the use of cookies.