Sartorius, a major provider of equipment to the biopharmaceutical industry (and a stakeholder of bioprinitng hardware and materials company BICO), has shifted its focus to producing biocompatible components essential for the production of biologics. Working with Materialise, the company has produced 26,000 biocompatible devices since 2018.
Biocompatibility is a critical requirement for these components, but the definition varies among suppliers, leading Sartorius to conduct extensive testing and verification on the materials themselves.
Stringent industry regulations and the need for biocompatibility and traceability make the production of single-use parts a highly controlled process. Sartorius’s commitment to quality has earned them a strong reputation in the pharmaceutical industry, with major pharmaceutical companies among their clients.
To meet their manufacturing needs, Sartorius turned to additive manufacturing (AM) using PA 12. While the biopharmaceutical industry has been cautious in adopting AM due to safety and regulatory concerns, Sartorius carefully evaluates when and how to use AM based on its suitability for each project and its potential to add value.
“Our production developers and AM designer lead the design of our single-use components, but we receive a lot of very valuable input from the process engineers and project managers at Materialise that is taken onboard and fed back into our design processes,” explained Tim Gabbitas, Additive Manufacturing Specialist at Sartorius. “Especially during the qualification process and when moving into certified manufacturing, when we have conversations about things like cleanability and tolerances.”
Materialise, as a certified manufacturing partner, ensures strict compliance with standards like ISO 9001 and offers a collaborative approach, addressing not only numerical standards but also environmental factors and customer feedback.
Material selection is a critical aspect of the process, considering factors like biocompatibility and extractable and leachable. PA 12 was chosen for most of Sartorius’s single-use components after thorough testing and validation. The result of this collaboration has been the production of thousands of truly biocompatible parts trusted by major pharmaceutical companies, including their use in producing mRNA COVID vaccines.