Project Description

Intec Foams were approached by a Blue Chip medical company to help with the development of a foam product for use in a medical device, where the foam came into direct contact with the body both internally and externally.

The foam product needed to be cut to a certain size and shape which was a key to the functionality as was the foam selection. It was established that the foam was to meet ISO 10993 for In-Vitro Cytotoxicity, primary skin irritation and skin sensitisation and that we set up a “laundering” procedure to remove and monitor bio-burden.

Our experience determined that we chose reticulated foam with good water and chemical resistance, and to develop a bespoke machine for the actual conversion of the foam into the specific design.

Our Engineers developed a machine and process capable of consistent long term manufacture.

We worked with a specialist company in the field of Clean room Laundry, to develop a process which met the client’s criteria, plus a manufacturing protocol for each batch processed, so that we limited contamination at the cutting stage. Complete trace ability of each batch of foam was included as part of our internal quality assurance systems.

Once the basic specification and prototype samples were approved, we worked with the client by supplying samples for the testing of the foam for approval to ISO 10993 tests.

By using our technical knowledge, innovation and working as part of a team with our client, we successfully developed the product and samples for both trials and medical approvals, in order to get the product to Market.