Stockwell Elastomerics’ Support for the Medical Device Industry

Stockwell Elastomerics supports many applications for fabricated and molded gaskets and related articles used in medical equipment that do not have direct contact with the body.

Stockwell Elastomerics does not provide fabricated or molded articles that are designed for use in the body or articles that make direct contact with wounds or irritated skin. The company is open to serving gasket requirements for applications with incidental contact with body fluids and waste. The company has on-going business relationships with many of the major medical equipment providers, molding and fabricating components in its industrial facility for medical devices utilizing best practices. However, the company does not fabricate in a clean room, and the expectation is for the customer to sterilize the articles prior to assembly when applications dictate this level of cleanliness.

Stockwell Elastomerics generally uses platinum cure silicone rubber for medical device applications. The silicone providers most frequently used by Stockwell Elastomerics for medical applications are Specialty Silicone Products and Wacker Silicones. Both have silicone compounds developed for high purity requirements that pass FDA CFR 177.2600, USP Class VI and are RoHS compliant.

The protocol for manufacturing gaskets and similar articles identified for use in medical devices is generally detailed as:

1. Remove the molded or fabricated article from the tooling.
2. Inspect for defects such as inclusions, non-fills and other causes for rejection.
3. Remove flash with hand-trimming or cryogenic de-flashing.
4. Remove any residual loose flash and incidental debris (FOD) with an alcohol (IPA) damped lint-free cloth.
5. Bag the article – number of parts per bag as agreed upon with the customer.
6. Double bagging is an option as agreed upon with the customer.

Medical Applications

Stockwell Elastomerics offers:

• Medical Diagnostics Devices Applications for Silicone Gaskets and Cushioning Pads
• Medical Grade Silicone Rubber