For medical device products and pharmaceutical packaging applications such as pre-filled syringes, it is helpful to our customers in these markets to know that the polymers, colorants and additives used in compounding custom colors are part of a Drug Master File (DMF). A DMF is a confidential, detailed document submitted by Active Pharmaceutical Ingredient (API) manufacturers to the U.S. Food & Drug Administration. A DMF contains the chemistry, manufacturing and controls of a drug component or the components used to contain the drug. This is important because some drugs can react with the polymer containers and packaging (or syringes) and produce a negative effect on the drug itself.
There are five types of DMFs: Type I covers manufacturing sites, facilities, operating procedures and personnel not specific to drug substances. Type II covers drug substances, substance intermediates and materials used in their preparation, or a drug product. Type III covers the packaging materials from bottles and caps to PVC resin used in their manufacture, which must be covered in a DMF or other FDA document such as an NDA (New Drug Application). Type IV covers excipients (chemically inactive substances), colorants, flavors, essences or materials. Type V covers FDA accepted reference information not included in the other Types.
Why is this important for our customers in the medical device and pharmaceutical markets? Using the colorants and materials already contained in the FDA’s DMF helps save time and can result in faster approvals. If a customer’s product must be FDA approved, selecting a color from a DMF results in faster time-to-market. Plastics Color Corporation has a strong catalog of approved DMF whites and colors that provides customers with the convenience that a DMF-listed ingredient in a medical device or pharmaceutical package/container provides.
Want to know more about our approved DMF offerings? Give us a call and we can help you with your next project.