ECH (ethylene chlorohydrin) residues - Plastic catheter packed in a sterile bag

[Soog1459]

Now I'm working with sterilization validation of a new product.

Our contract EtO (ethylene oxide) sterilization company, new for my company, said that we don't need to measure ECH residue because chlorine (Cl) is not included in our product.
Our product is a plastic catheter packed in a sterile bag.

I'm not familiar with chemical reaction.
Does their rationale make sense and satisfy a regulatory body??

Thank you!

 

[planB]

Soog1459,

you would have to demonstrate, that not only through your product materials, but that you also do not introduce any chlorine-containing compounds through your manufacturing processes (including those of any suppliers)

Therefore it is much easier and less risky to get challenged, when you demonstrate compliance to ISO 10993-7:2008 by measuring EO and ECH levels for your device explicitly.

HTH,

Gerhard

 

[Soog1459]

planB,

Thanks to your advise!

Now I know a new concern.
If we leave our manufacturing process no-chlorine-containing-controll, ECH measurements at initial & re-qualification timing (once a year) are enough for the demonstration?

I'm afraid that measurement at every batch is required...
Too much concern??

 

[MIREGMGR]

I don't know if your intent is to distribute in the US. If so, US FDA is likely to not accept an argument that ECH shouldn't exist for chemical reasons, and instead expect both EO and ECH residuals to be addressed traditionally in your process validation.

That however is not a disadvantage. It's much easier to perform a one time conventional process validation per 11135-1, including residuals validation per 10993-7, repeated at the appropriate interval per the standards for your process character and product type, than it would be to make and defend a non-standard technical argument as to why your process can and should be different, and also have to provide a justification for the non-standard re-validation interval you propose.

 

[planB]

Soog1459,

>If we leave our manufacturing process no-chlorine-containing-controll, ECH measurements at initial & re-qualification timing (once a year) are enough for the demonstration?

>I'm afraid that measurement at every batch is required...

Adding to all the valid points that MIREGMGR made:

It is _you_, the manufacturer, who determines the time frames and extent of re-validation activities according to ISO 11135:2014, based on sound and documented rationales, including also a risk management process.

For example, if you are far off the limits defined in ISO 10993-7 (e.g. 2 or 3 logs) you may justify less frequent residual re-qualification based on the large margin of safety of your actual values compared to the defined limits of the standard. But it's typical to re-test residuals not later than every third or even second year.

On the other hand, do you think your product has characteristics that may necessitate quantifying residual for every batch, like e.g. its intended use?

HTH,

Gerhard

 

[Soog1459]

MIREGMGR, planB,

I don't know if your intent is to distribute in the US. If so, US FDA is likely to not accept an argument that ECH shouldn't exist for chemical reasons, and instead expect both EO and ECH residuals to be addressed traditionally in your process validation.

hmm... I will see same result in Japan.
They are Europian company. I don't know why they can skip ECH measurement...

On the other hand, do you think your product has characteristics that may necessitate quantifying residual for every batch, like e.g. its intended use?

No, no. Just my concern.
I will check documents and logic of other products, and discuss how we can solve with process engineer.


Thank you for your technical knowledge and advises!