Clean Room Classification for Contact Lens Packaging

[galit]

Hello,
I'm working in a company that produce and packing contact lenses. we are new in packaging the contact lenses in blister and we need help to decide the class of the laminar flow that will cover the blisters machine.
The machine is in clean room (class 8), should we package the contact lens in a higher class?

 

[Marc]

A quick "Bump". My Thanks in advance to anyone who can help with this one.

 

[galit]

Thank you, it is very imprtent to us, if someone knows the answer or can guide us on the classification of blisters packaging process.

 

[pkost]

For the EU, as far as I am aware (I don't have any knowledge of contact lens specific standards), there are generally no specific requirements for cleanroom level. The level is chosen by the manufacturer to be sufficient to ensure the cleanliness and sterility of the product.

That being said, I doubt class 8 would be sufficient, there would be quite a relatively high chance of particles dropping into the blister

 

[liuyy]

In China,all contact lense manufacturers I knew had their products cleaned and packed in ISO class 8 cleanroom.