Medical Products Meet Standards
HMC Polymers medical products meet all applicable European Pharmacopeia (EP), Drug US Pharmacopeia (USP) and Master File (DMF) Standards.
The European Pharmacopeia (EP)
The European Pharmacopeia (EP) provides the healthcare producer with guidelines to properly select appropriate plastics materials for medical applications in Europe. It lists the details of allowed additives to be used in specified resins and the chemical testing required for the medical applications.
The Drug Master File (DMF)
The Drug Master File (DMF) contains pertinent information such as resin formulation, manufacturing process and toxicology test data according to the United States Pharmacopeia (USP) as requested by the US Food and Drug Administration (FDA).
Medical device manufacturers can request permission to use the information stored in the DMF to support their application at the US Food and Drug Administration (FDA). After approval, the government agency will allow the importation of those resins to the United States.
HMC Polymers includes a declaration that medical products meet the above requirements in our HMC RAPIDS documents (Regulatory Affairs Product Stewardship Information/Certification Data Sheets) available for download per product from the HMC Polymers website – Product Table.
Medical grade example: Purell RP271G
- European Pharmacopeia (EP)
This product meets the EP requirements for 3.1.6, Polypropylene (For Containers, Preparations and Parental Use). - Drug Master File (DMF)
Information on this product is listed in DMF# 23969. Contact HMC for a DMF authorization letter to be sent to FDA. - US Pharmacopeia (USP)
Representative samples of this product have passed the <88> USP Biological Reactivity Tests, In Vivo for a Class VI plastic (Systemic Injection Test, Intracutaneous Test, Implantation Test. Results provided by Seller are intended to be representative in nature only and are not to be construed as a guarantee of future product performance. Seller makes no express or implied warranty by virtue of disclosing pass/fail status.
It’s important for our customers to know that the medical grades they purchase from HMC Polymers are manufactured and controlled per these universally accepted codes, and that those resins meet globally recognized high standards.
Contact HMC Polymers Sales to discuss how our family of PP grades can not only allow your packaging to be stronger, lighter, clearer and easier to process; but also certified for medical applications.