Plastics are widely used for medical and pharmaceutical applications, including packaging, medicine bottles, dental and surgical tools, catheter tubing and other uses.
Having an up-to-date DMF is an indication of both credibility and reliability. Plastics Color Corporation offers a catalog of colors, additives and concentrates packaged with FDA-accepted DMFs.
All materials used for the storage or packaging of drugs and medical supplies fall under the FDA’s Type III designation. Filings are not required, but maintaining DMFs offers a range of business advantages, including:
Type III DMF files also apply to housing devices whose components may be exposed to drug substances, including individual and pressurized containers, bulk containers, cap closures, liners, inner seals, resins/elastomers and valve closure systems, according to APG-Pharma.com, a European laboratory and pharmaceutical packaging company.
Most such components are manufactured with polyethylene or polypropylene resins, both of which are compliant with food additive regulations (FAR). Certain colorants and functional additives may also chemically affect drug substances, so they, too, need DMFs on file.
The FDA also takes into consideration any material properties that might affect the safe use of plastics with drugs or medical supplies, including:
Any such properties could interact negatively with certain drugs and materials, which could in turn cause serious harm or result in reduced effectiveness of the product.
Medical and pharmaceutical companies have a responsibility to ensure that their products meet safety guidelines and protect consumers against harmful substances and reactions. DMFs provide a way to validate the facilities, materials and substances used to manufacture and package drugs and medical devices.
DMFs can be a complex and time-consuming process that can slow product development. Plastics Color Corporation offers a catalog of FDA-accepted DMFs for pharmaceutically safe colors, additives and concentrates. Because Plastics Color owns the DMFs, brand owners are able to change molders or packaging facilities as they prefer.
For more information about DMFs, as well as our quality compliance and lab services, please fill out the contact form located at the bottom of this page.