14 October 2013

Medical Applications Standards

HMC Polymers’ Purell is the benchmark polypropylene used by global manufacturers for medical and pharmaceutical applications including IV bottles, syringes and pharmaceutical packaging. Regulatory requirements affect the manufacture of medical and pharmaceutical products making demands on medical devices and packaging. Purell is produced under near-pharmaceutical conditions and utilizes dedicated cleaning procedures for product logistics.

For the use of plastics in medical applications, the European Union has developed the European Pharmacopeia directive (EP 3.1.6) describing the use of “Polypropylene for Containers and Closures for Preparations for Parenteral and Ophthalmic Use”. This directive provides guidelines and information to allow medical and pharmaceutical product manufacturers to make informed choices of the selection and use of plastics for medical and pharmaceutical applications.

EP3.1.6 regulates:

  • The list of permitted additives
  • The amount of additives allowed to be added to the polymer
  • Testing conditions of medical packaging in terms of their chemical, physical and mechanical properties

Similarly, other countries have developed their own standards, e.g. United States Pharmacopeia (USP) and Chinese SFDA. In addition to the European Pharmacopeia, United States Pharmacopeia – USP Class VI related to plastics is also a widely adopted standard to verify the safety of plastic materials used in medical and pharmaceutical applications.

All Purell PP grades produced by HMC Polymers are tested according to the European Pharmacopeia (EP 3.1.6) and United States Pharmacopeia (USP) Class VI plastic and are listed in the Drug Master File (DMF). For all Purell products HMC declares EP 3.1.6, USP Class VI plastic and DMF in our HMC RAPIDS (Regulatory Affairs Product Stewardship Information/Certification Data Sheet) which are downloadable for each commercialized resin.

HMC provides our customers with all pertinent information to support product submissions to government agencies, e.g. the Drug Master File (DMF). In the United States, the DMF is submitted to the Food and Drug Administration (FDA). The main objective of the both the US and European DMF is to support regulatory requirements and to prove the quality, safety and efficacy of the selected medical resin and manufactured product.

It is important to mention that before using an HMC Polymers product, customers and other users should make their own independent determination that the product is suitable for the intended use. It is the sole responsibility of the manufacturer of drug or medical devices or medical and pharmaceutical packaging to prove the safety of its product.

Purell PP grades have been trusted by customers for medical and pharmaceutical applications for over thirty years. For more information, contact HMC Polymers Sales at: sales@hmcpolymers.com