Sartorius, a serious supplier of kit to the biopharmaceutical business (and a stakeholder of bioprinitng {hardware} and supplies firm BICO), has shifted its focus to producing biocompatible parts important for the manufacturing of biologics. Working with Materialise, the corporate has produced 26,000 biocompatible gadgets since 2018.

Biocompatibility is a important requirement for these parts, however the definition varies amongst suppliers, main Sartorius to conduct intensive testing and verification on the supplies themselves.

Stringent business laws and the necessity for biocompatibility and traceability make the manufacturing of single-use components a extremely managed course of. Sartorius’s dedication to high quality has earned them a powerful status within the pharmaceutical business, with main pharmaceutical firms amongst their shoppers.

To fulfill their manufacturing wants, Sartorius turned to additive manufacturing (AM) utilizing PA 12. Whereas the biopharmaceutical business has been cautious in adopting AM resulting from security and regulatory considerations, Sartorius fastidiously evaluates when and learn how to use AM primarily based on its suitability for every mission and its potential so as to add worth.

“Our manufacturing builders and AM designer lead the design of our single-use parts, however we obtain plenty of very worthwhile enter from the method engineers and mission managers at Materialise that’s taken onboard and fed again into our design processes,” defined Tim Gabbitas, Additive Manufacturing Specialist at Sartorius. “Particularly in the course of the qualification course of and when shifting into licensed manufacturing, when we have now conversations about issues like cleanability and tolerances.”

Materialise, as a licensed manufacturing associate, ensures strict compliance with requirements like ISO 9001 and presents a collaborative strategy, addressing not solely numerical requirements but additionally environmental elements and buyer suggestions.

Materials choice is a important facet of the method, contemplating elements like biocompatibility and extractable and leachable. PA 12 was chosen for many of Sartorius’s single-use parts after thorough testing and validation. The results of this collaboration has been the manufacturing of hundreds of actually biocompatible components trusted by main pharmaceutical firms, together with their use in producing mRNA COVID vaccines.