Verifying item is sterilized

homeOwner

Not sure if this is the right place to post this....

How does one ensure that a manufactured plastic item is sterilized? Is there an EU standard test or are there guidelines for plastic manufacturing to ensure something is sterile when packaged? Something like a syringe for instance, how does one know for sure it is sterile before use?

locum-motion

homeOwner wrote: »

... Something like a syringe for instance, how does one know for sure it is sterile before use?

If it's still in its sealed package, and has not passed its expiry date, it's sterile.

KP81

There is a tonne of regulations on sterilisation on the EMA website. Typically this body issues guidelines like this http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003520.pdf
and the company will perform testing to meet the guidelines. Also, this topic would be covered by the EU GMP directive and the IVD directive.

Each batch of products (eg syringe) would get a unique batch number (note needles usually seperate and would have a different batch number). You could contact the supplier to get a copy of the sterilisation certificate which would be issued with this batch when released by QA. This number should be printed on the packaging or even on the syringe itself. If the packaging is breached in any way it is not sterile. In my opinion once the syringe has left the regulated supply chain (eg pharmacy) it should be treated as non sterile as there is no way to prove sterility has been maintained.

Proving something is sterile is quite difficult. Anyone can stick a syringe in an autoclave or gamma irradiate it but validating these methods to prove sterility requires a huge amount of equipment qualification and micro testing. It would be easier to obtain a new syringe from a new batch if there is any doubt.

homeOwner

locum-motion wrote: »

If it's still in its sealed package, and has not passed its expiry date, it's sterile.

I meant how do you know it was sterile before it was packaged.

homeOwner

KP81 wrote: »

There is a tonne of regulations on sterilisation on the EMA website. Typically this body issues guidelines like this http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003520.pdf
and the company will perform testing to meet the guidelines. Also, this topic would be covered by the EU GMP directive and the IVD directive.

Each batch of products (eg syringe) would get a unique batch number (note needles usually seperate and would have a different batch number). You could contact the supplier to get a copy of the sterilisation certificate which would be issued with this batch when released by QA. This number should be printed on the packaging or even on the syringe itself. If the packaging is breached in any way it is not sterile. In my opinion once the syringe has left the regulated supply chain (eg pharmacy) it should be treated as non sterile as there is no way to prove sterility has been maintained.

Proving something is sterile is quite difficult. Anyone can stick a syringe in an autoclave or gamma irradiate it but validating these methods to prove sterility requires a huge amount of equipment qualification and micro testing. It would be easier to obtain a new syringe from a new batch if there is any doubt.

Thanks thats what I was looking for......