Biopharma Plastic Solutions

Plastics solutions for the pharmaceutical and biopharmaceutical industry

In the biopharmaceutical and pharmaceutical sectors, the highest demands are placed on materials and manufacturing processes. Façade Creations 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.

You can reach our Biopharma Plastic Solutions team through our contact form for a quick and easy enquiry. We will get back to you promptly.

(However, if you prefer to speak to someone directly? Call our aerospace team or email us and we’ll respond promptly.)

Team Contact Form

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Key characteristics of the pharmaceutical and biopharmaceutical industry

The pharmaceutical and biopharmaceutical industries are in constant growth, and both segments produce drugs – but what’s the difference between the two?

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

Biopharma:
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 comes into play, closely linked to biopharma – in simple terms, all biopharma products originate from biotechnological research.

Benefits for the pharmaceutical industry

Quality management system Global expertise Traceability Compliance

DIN EN ISO 13485:2016

Façade Creations has introduced a quality management system in accordance with DIN EN ISO 13485:2016 across many areas of our development, production and distribution of thermoplastics at our facilities. With this certified quality management system, Façade Creations offers its

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 Façade Creations 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, consistent traceability with regard to the products and the raw materials used is standard at Façade Creations. For plastic materials within our medical-grade standard portfolio, a declaration of conformity is 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 manufacturing process as unchanged as possible. In case of changes, high evaluation standards apply within the scope of our medical-grade change management, and customers are informed of relevant changes as early as possible through a formal change notification. The aim is always to provide equivalent products despite any necessary adjustments.

One-Stop Shop for the Biopharmaceutical and Pharmaceutical 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 our broadly based value chain, Façade Creations offers optimum conditions for finished or semi-finished parts for the pharmaceutical and biopharmaceutical industries. Depending on the requirements profile, we offer 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 food-and-drug regulatory compliance.

Finished Parts Suitable for the Biopharmaceutical and Pharmaceutical Industry

  • Machined parts
  • Profiles
  • Customised tubes

Products Suitable for the Biopharmaceutical and Pharmaceutical Industry

  • Shapes (rods, plates, tubes)

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 our medical-grade standard portfolio are tested according to ISO 10993 pursuant to their intended use, preferably on the finished product, and they fulfil the requirements specified in the respective test. The evaluation of biocompatibility can also be completely adapted to a customer’s individual needs. Our medical-grade plastics are often a very good metal substitute, and due to their light weight, high-performance plastics are frequently used to replace metal across these industries.

By offering high-performance plastic solutions that meet the requirements of the pharmaceutical industry, Façade Creations has also gained experience working with respected partners at numerous levels of the industry’s supply chain. Certain Façade Creations products are also suitable for single-use applications: together with our customers, we have demonstrated significant advantages over typical stainless-steel components. For example, a 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 both users and patients.

Biocompatible plastics
Plastic materials within our medical-grade standard portfolio are tested according to ISO 10993 pursuant to their intended use, preferably on the finished product, and they fulfil the requirements specified in the respective test. Evaluation of biocompatibility can also be completely adapted to a customer’s individual needs.

Chemical-resistant plastics
When selecting plastics for the pharmaceutical industry, chemical resistance is an important characteristic for material selection. Due to their good chemical resistance, our plastics can come into contact with cleaning agents and other media without becoming brittle or yellowing.

Sterilisable plastics
Depending on the area of application, plastics can come into contact with different types of sterilisation. Gamma radiation or superheated-steam sterilisation, for example, is often important for components used in the pharmaceutical industry.

FDA-compliant plastics
Plastics in the pharmaceutical industry often have to fulfil good manufacturing practice (GMP) requirements – meaning the plastic must not have any negative impact on the quality of the pharmaceutical product. A food-contact declaration is often used as evidence of this compliance.

BSE/TSE-free plastics
No animal substances are used in the recipe of our products’ manufacture. Plastic materials may, however, contain secondary products or derivatives of animal origin – usually fatty acids or fatty-acid esters produced according to recognised international guidelines on transmissible spongiform encephalopathy (TSE) risk. In most cases, our plastics comply with these guidelines either because they contain no substances of animal origin, or because the manufacturing processes used are suitable for inactivating transmissible agents of this kind.

USP Plastic Class VI compliant plastics
USP Plastic Class VI is a recognised standard for evaluating and testing the biocompatibility of plastics. There are six classes in total, of which Class VI carries the most demanding requirements. Originally intended for testing pharmaceutical packaging, USP Plastic Class VI compliance is now frequently required for product-contacting materials and components used in pharmaceutical processing more broadly.

Application Examples

Capillary carouselused for PCR analysis in medical technology

  • 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

Manufactured using an injection-moulded and machined black medical-grade PEEK material.

Thermoformable tube – manufactured using a natural medical-grade PEEK material

  • Tested and evaluated according to ISO 10993 (parts 1, 4, 5 and 18)
  • Weldable while maintaining a high dimensional stability

Small medical-grade tube – manufactured using a natural medical-grade PEEK material

  • Biocompatible according to ISO 10993 (parts 1, 4, 5 and 18)
  • Customised dimensions
  • Precise tolerances