Tricor Braun Weighs in on Postconsumer Recycled Content

Are postconsumer-recycled (PCR) materials allowed for packaging OTC drug products such as sunscreen, salicylic acid, and benzoyl peroxide products?

Tricor Braun, a supplier of bottles and related components, provided the following answer to CPC after the Webcast. We thought it would interest PMP News readers:

“This can be done, but there are two issues:

1. The resin grade would have to be FDA approved. This would mean the submission of Drug Master Files (DMFs), which adds a lot of time to the picture. There would also be the need for stability testing.
2. The first issue can be overcome. But it is difficult and requires finding a cGMP-compliant molder as well as a good, clean, reliable, and consistent source, which usually proves to be expensive. These streams do exist today, but few have taken the time to develop a medical grade.

Companies asking for such PCR packaging would be somewhat alone in their request, which adds to the expense and to the timeline. A limited number of suppliers have some clean and reliable PCR streams, but have not gone so far as to get the proper approvals.

There are a few other options:

1. Make a multiple-layer bottle and sandwich the PCR…but then you are adding cost, and there will still be a need to gain DMFs and other approvals as well as stability testing.
2. There are recyclers that recycle not by washing but by breaking down all the way to the monomer and then reconstructing the polymer. They are reusing the petroleum but getting a virgin stream. Not all polymers are available, but I think that HDPE is now available and that PET is as well. I have not looked at price but I would think the premium is minimal. I don’t know whether they have all the approvals for medical-grade polymers. But I don’t see any issue with these products gaining them.

I am unaware of anyone using PCR for OTC drug packaging. It could be done, but it would come down to the customer’s willingness to move, pay for it, and deal with redoing stability if USP 661 as a replacement test is not accepted. It would also depend upon a supplier’s ability to be able to secure and guarantee a source of clean, consistent, and reliable PCR in whatever resin the customer wants.”

Jad Darsey, Strategic Markets Sales Manager