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Benefits of DMFs for the Medical and Pharmaceutical Industries

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.

The 3 Primary Benefits of 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:

  1. Faster FDA Approval: Having up-to-date DMFs for drug containers, bags, closures and other components greatly reduces the time required for FDA approval. A faster review process means that products can get to market more efficiently.
  2. Confidentiality: DMFs provide a way to maintain transparency with the FDA while protecting proprietary manufacturing processes and procedures. DMFs are required when two or more firms work together to manufacture a product.
  3. Flexibility: Supplier-maintained DMFs allow for greater flexibility when changing vendors and packaging partners. A pharmaceutical company that uses Plastics Color for colorants, compounds or masterbatches can contract with any molder or packaging facility without having to refile a DMF.

Type III DMFs and Drug Packaging Materials

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:

  1. Light exposure
  2. Reactive gases
  3. Moisture permeation/water vapor transmission
  4. Extractables
  5. Child resistance

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.

Plastics Color Corporation and DMFs

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.

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