3 replies to this topic

[MaartjeD]

We are a Biotech company in Europe, producing a Food processing aid. It is difficult to find EU/FDA Food Grade plastic food contact materials (tubing, bags) for our process. All materials are USP Class VI compliant. Will this cover EU/FDA requirements for Food Contact materials?

 

Thanks for your assistance on this matter

Maartje

[pHruit]

I think your challenge is going to be that there doesn't seem to be complete overlap between the USP cat. VI requirements and those of Regulations 1935/2004 and 10/2011 - without confirmed compliance to these, I'm not sure how you can show that you're meeting food contact requirements for the EU.

What specific equipment is it that you're looking for?
For pipework there are usually plenty of options in stainless steel, and a large variety of flexible hoses. Similarly there are a wide range of bags for food-contact packaging applications.

[MaartjeD]

Thanks for your reply. We need weldable tubing that can be welded to 50-500 L plastic bags to make sterile connections. Quite a challenge to find these tubing and bags in Food Grade quality.

[pHruit]

Hmm, does indeed sound like an interesting challenge!

As you mention welding, I'm assuming this is for a permanent fixture of some sort?
Is it essential that the "bag" part is flexible?
Is the product liquid, or dry/powder?

Just wondering if steel pipework and fixed steel tanks could work instead? You can then sterilise using e.g. steam as part of your cleaning cycle, as would be the case for various aseptic process/filling systems.

I know it's possibly a stupid question, but I presume you've tried talking to the plastics suppliers about the food-grade requirements?