Machined parts for pharmaceuticals and biopharmaceuticals

The production of systems for the pharmaceutical industry is confronted with special challenges that can only be met by adhering to strict regulations. The Ensinger Machined Parts team already has years of experience in this industrial sector. With validated equipment and qualified processes, as well as a clean room classified according to DIN ISO 14644-1 class 7 (operation) or ISO 6 (idle), Ensinger offers safety for customers and patients. 

Machinable materials for biopharma and pharma

In addition to the classic semi-finished products, industrial profiles or injection moulded blanks from the in-house production areas are also available as a basis. In this way, material costs can be saved and processing times reduced for large quantities by using geometrically accurate blanks. Our staff will be happy to advise you on this.

Below you will find a list of all plates, tubes and round rods for the machining of products for biopharmaceuticals and pharmaceuticals. We mainly machine internally produced materials. However, if the selection does not include the right material for your application, we can also machine external materials.

Key Material properties for Biopharma and Pharma

  • Plastic materials within the Ensinger MED- / MT-standard-portfolio are tested according to ISO 10993 pursuant to their intended use, preferably on the product. They fulfil the requirements specified in the respective test. However, the evaluation of biocompatibility can also be completely adapted to the customer's individual needs.
  • When selecting plastics for the pharmaceutical industry, chemical resistance is an important characteristic for the selection of materials. Due to their good chemical resistance, our plastics can come into contact with cleaning agents and other media without becoming brittle or yellowing.
  • Depending on the area of application, plastics can come into contact with different types of sterilisation. Depending on the area of application, gamma radiation or superheated steam sterilisation is important for components in the pharmaceutical industry, for example.
  • Plastics in the pharmaceutical industry often have to fulfil GMP requirements, i.e. the plastic must not have a negative impact on the quality of the pharmaceutical product. An FDA declaration of food suitability is often used as proof.
  • In a broader sense, "ADI free" is often specified in the manufacture of pharmaceutical products. The ADI specification states that no materials of animal origin were used (ADI free = raw materials contain no Animal Derived Ingredients). Materials with this specification are also free of TSE or BSE (TSE = Transmissible Spongiform Encephalopathy; BSE = Bovine Spongiform Encephalopathy).
    No animal substances are used in the formulation of our plastics. Plastics may, however, contain derived products or derivatives of animal origin. However, the additives are in turn exposed to temperatures of over 200 °C when the plastics are compounded into granulate and further processed. Because of these processes, it is difficult to imagine that thermoplastics with additives obtained by chemical transformation of animal raw materials contain active, transmissible TSE/BSE agents. We do not routinely test for the presence of these substances and analytical monitoring of possible contamination is not part of the outgoing inspection.
    Please contact us directly if you have specific questions about individual plastics.

  • USP testing is a standard for evaluating and testing the biocompatibility of plastics. There are six classes in total, of which USP Plastic Class VI has the highest biocompatibility requirements. USP Class VI testing is designed to demonstrate that there are no harmful reactions or long-term physical effects from chemicals leaching from plastics.
    The test is issued by the United States Pharmacopeial Convention (USP), the organisation that establishes standards in the United States regarding the identity, quality, purity, labelling, packaging and storage of pharmaceuticals.
    Ensinger has numerous products in its portfolio that meet the requirement and use USP Class VI tested raw materials.

application Examples

Ensinger is a specialist in the certified production of machined pharmaceutical components under the standards of ISO 13485. Together with our long-standing partners, entire product lines have already been developed into a qualitative market-leading position.

Capillary carousel for PCR-Analysis

  • Low thermal expansion at fast temperature changes
  • Good chemical resistance to disinfectants and detergents
  • High precision machining
  • Intensive pigmentation (deep black) allows very accurate measurement results