Plastics solutions for the pharmaceutical and biopharmaceutical industry

In the biopharmaceutical and pharmaceutical sectors, the highest demands are placed on materials and manufacturing processes. Ensinger can draw on many years of experience in these areas. Using proven materials and process technologies, we work with our customers to find tailor-made solutions and continuously develop our product range to create alternatives made from high-performance plastics. 

Key characteristics of the pharmaceutical and biopharmaceutical industry

The pharmaceutical and biopharmaceutical industries are in constant growth and both biopharmaceuticals and pharmaceuticals produce drugs. But what is the difference between the two industry segments?


These products are mainly derived from chemical and synthetic processes. Sometimes the medicines are also created in combination with herbal substances.


Here, living organisms such as bacteria, cells or yeast are used to produce drugs. Biopharmaceuticals are therefore based on biological methods. This is where biotechnology (biotech for short) comes into play, which is closely linked to biopharma and, simply put, all biopharma products are originally created in biotechnological research.

Benefits for the pharmaceutical industry

DIN EN ISO 13485:2016

Ensinger GmbH has introduced a quality management system in accordance with DIN EN ISO 13485:2016 in many areas for the development, production and distribution of thermoplastics at its Nufringen and Cham sites. With this certified quality management system, Ensinger offers its customers additional security. 

Profound experience

Our experience in the medical industry helps us to work with our customers to develop the best solutions, from product design through to manufacture.

We are where you are

Thanks to the global presence of the Ensinger team in the medical industry segment, our customers on all continents are able to benefit from our high-quality solutions.

Order-related and consistent

Due to strict documentation during the individual process steps, consistant traceability with regard to the products and the raw materials used is standard at Ensinger. For plastic materials within the Ensinger MED- / MT-standard-portfolio, a declaration of conformityis issued on an order related basis. This enables our customers to have clear traceability.

Reliable change notification

For medical grade products, the aim is, to keep the materials and the manufacturing process as unchanged as possible. In case of changes, high evaluation standards apply within the scope of the medical grade change management and the customers are informed of relevant changes as early as possible with a change notification. The aim is, to always provide equivalent products despite necessary adjustments. 

 ONE-STOP SHOP for the biopharmaceutical and pharmaceutical industry

Ensinger value chain for the biopharma industry

As a full-service provider of solutions for the pharmaceutical and biopharmaceutical industry, we focus on a fully integrated value chain. All process steps - from compound to finished component - can be covered under one roof. To meet the high demands of the industry, we produce suitable polymer compounds in-house, which are further processed into customised solutions using our broad portfolio of plastics processing technologies. With a wide range of further processing options, we produce ready-to-use components that are precisely tailored to our customers' requirements.

Thanks to its broadly based value chain, Ensinger offers optimum conditions for finished or semi-finished parts for the pharmaceutical and biopharmaceutical industries. Depending on the requirements profile, we offer additively manufactured prototypes, high-precision machined parts, cost-efficient injection-moulded parts in large volumes or customised tubes, rods and hoses. To minimise risk, plastics used in the biopharmaceutical and pharmaceutical industries must meet the detailed requirements of end users and system suppliers. Different applications place different demands on materials, such as sterilisability and autoclavability, chemical resistance or FDA compliance.



Material solutions for pharmaceutical and biopharmaceutical systems

High-performance plastics are well suited for the pharmaceutical industry due to their durability, sterilisability and very good machinability towards demanding geometries and specifications while remaining highly cost-efficient. 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. Ensinger Medical Grade (MT) plastics are often a very good metal substitute. With our Ensinger Medical Grade (MT / MED) standard portfolio, we offer a wide variety of materials that are very well suited for the use in biopharmaceutical and pharmaceutical applications. Due to their light weight, high-performance plastics are often use to replace metal in these industries.
By offering solutions for high-performance plastics that meet the requirements of the pharmaceutical industry, experience has also been gained with respected suppliers at numerous levels of the industry's supply chain. Certain Ensinger products are also suitable in the single-use sector: together with our customers, significant advantages over typical stainless steel types have been demonstrated. For example, the single-use approach completely eliminates the need for cleaning and cleaning validation in the end application, as well as the risk of cross-contamination. This shortens downtimes and increases plant productivity. In addition, single-use systems in pharma and biopharma provide additional protection against hazardous substances for users and patients.

  • 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. A food contact declaration according to the FDA is often used as proof.
  • In the manufacture of our products no animal substances are used based on the recipe. However, plastic materials may contain secondary products or derivatives of animal origin. In most cases, these are fatty acids or fatty acid esters produced according to the specifications of guideline EMA/410/01 Rev. 3, section 6 or according to the specifications of the WHO Guidelines ( WHO Guidelines on Tissue Infectivity Distribution in Transmissible Spongiform Encephalopathies, 2006).
    Usually our plastics comply with the requirements of these guidelines either because they do not contain substances of animal origin or because the manufacturing processes of the derived products are suitable to inactivate transmissible TSE/BSE agents.

  • USP Plastic Class VI is a standard for evaluating and testing the biocompatibility of plastics, which is defined in chapters <87> and <88> of the USP. There are six classes, of which USP Plastic Class VI has the highest requirements. Originally, the classification was intended for the testing of packaging for pharmaceutical products. The USP-NF ~ United States Pharmacopeia and National Formulary, is the official pharmacopeia of the United States of America. It is published by the United States Pharmacopeial Convention, the organisation that establishes standards in the United States regarding the identity, quality, purity, designation, packaging and storage of drugs. Currently, USP Plastic Class VI is often required for product-contacting materials and components used in the processing of pharmaceutical products.

Application examples

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

Thermoformable tube

made of TECAPEEK MT natural

  • Tested or evaluated according to standard ISO 10993-1, -4, -5, -18
  • Weldable while maintaining a high dimensional stability

Small medical grade tube

made of TECAPEEK MT natural

  • Biocompatible acc. ISO 10993-1, -4, -5, -18
  • Customised dimension
  • Precise tolerances

Case studies in the pharmaceutical industry

Manifold block

Manifold Block

made of TECADUR MT TR natural

Manifold Block in bioprocessing

In the manufacture of chemical fluid handling equipment, it is often necessary to machine parts that act as junctions between components in the fluid handling system in order to regulate fluid flow. Ideally they are transparent in order to verify fluid flow. They must have excellent chemical resistance, so as to not modify or introduce any leachable compound or chemical into the fluids they are handling.