Sterile or non-sterile stopcock?
This one is less about the part and more about your process. The same stopcock can be ordered ready-sterilised or as a plain component, and the right choice comes down to a single question: who does the final sterilisation, you or us?
If the stopcock leaves your hands and goes straight onto a patient, it has to arrive sterile, and that is on us. We run it through ethylene oxide, seal it in a pouch and validate the batch. If instead the stopcock is one piece inside a kit you build, or your customer sterilises their own stock, then it should come to you non-sterile, as a clean component you finish later. Order the wrong one and you either pay for sterilisation you will only undo, or you ship a kit that was never properly sterilised as a whole.
Why EO, and why the pouch matters
Plastic stopcocks are sterilised with ethylene oxide gas rather than heat or steam, because the gas can work its way into the tight mated surfaces inside the valve where the plug meets the body. Those surfaces are exactly the spots steam would miss. The catch is that the gas has to reach them through the packaging, so a sterile stopcock ships in a gas-permeable pouch, not a sealed plastic bag. That breathable barrier is what makes the sterile claim hold, and it is also what gives the part its dated shelf life. We validate the EO cycle per batch and hand over the documentation for your file.
Where the part sits in your kit
The other half of the decision is whether the stopcock is a finished device on its own or a component in something bigger. As a standalone item sold ready to use, sterile is the obvious call. But the moment it goes into a procedure kit with other parts, you usually want it non-sterile and bulk-packed, because you will sterilise the whole assembled pack as one unit at the end. Buying it pre-sterilised in that case just adds cost and a second sterile barrier you do not need. It also complicates dating, since a kit takes its shelf life from whichever part inside it expires first.
Shelf life shown is the industry-typical figure for an EO-sterile part in an intact pouch. We confirm the dated shelf life and sterilisation validation for your specific configuration before you order.
A note on the paperwork
Because we make the component and you hold the finished-device registration, the sterilisation status belongs on your spec and your label, not assumed. If you sell sterile, you will want the EO validation records for your file. If you assemble kits, you carry the validation for the finished pack and we simply supply a clean, traceable component to feed it. Either way we work to an ISO 13485 quality system with lot traceability, so the batch you sterilise is the batch you can document.
Common questions
It depends on who does the final sterilisation. If the stopcock ships ready to use on the patient, order it EO-sterile. If your customer sterilises in-house, or the stopcock goes inside a larger kit that you assemble and sterilise as a finished pack, order it non-sterile as a component. We supply either, with sterilisation validated per batch.
Plastic stopcocks are almost always sterilised with ethylene oxide (EO). The gas reaches the small mated surfaces inside the valve that other methods struggle with, which is why the pouch has to be gas-permeable. We validate the EO process per batch and provide the documentation for your file.
For an EO-sterile stopcock in an intact pouch it is commonly around three years, set by the validated sterile barrier rather than the plastic itself. A non-sterile component is simpler to stock because there is no sterile barrier to age. We confirm the dated shelf life for your specific configuration.
Yes. For kit assembly we supply non-sterile, bulk-packed to your configuration, so you sterilise the finished pack as one unit. Tell us the quantity and packing you need and we match it.
Tell us how you sell or assemble them, and we'll set it up right.
We make these stopcocks ourselves, sterile or non-sterile. Let Alex know whether they ship ready to use or go into your kit, and we'll come back with the right build, the sterilisation documentation, a sample to check, and an MOQ and FOB price, usually within a day.
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