Fitzgibbons said the Food and Drug Administration (FDA) is getting more and more detailed in its regulation of anything within the supply chain of a medical or pharmaceutical product, examining things like particle size, asking for vendor names, and drilling into all the things used to make the product. "Clariant wants to ensure to their customers that we will make the same product over and over and over, giving you a global palette," Fitzgibbons said.
At the show, Clariant expanded the Mevopur range to address:
- Low surface friction: An additive to lower friction between parts that must rotate or slide, improving the functionality of metered dose devices, as well as reducing the insertion resistance for catheters or eliminating oils in syringe components.
- MedX antimicrobial agents: additive packages using antimicrobial agents from Sanitized AG in polypropylene, polyethylene, and polycarbonate. MedX is a silver-based antimicrobial, and Clariant says that by incorporating it into the polymer in its Mevopur line, the company has removed the need for device manufactures to undertake a secondary antimicrobial coating operation, which has its own cost and validation processes.
- Permanent antistatics: Used to reduce electrical charges on the surface for smoother deliver of powdered drugs.
In addition, the company introduced what it called productivity-enhancing additives:
- Next generation nucleants and process aids: the Mevopur nucleants for injection molded medical devices can reportedly reduce cycle time by up to 12% depending on the polymer. By boosting crystallization, the materials become more rigid and have higher heat-distortion temperatures.
- Laser-marking additive: the indelible ink-free marking can help reduce concerns about solvent residues and offer a permanent mark made in a non-contact fashion.
- Enhanced sterilization production: a range of stabilizers to protect PP and cyclic olefin copolymer (COC) from yellowing and helping them maintain physical properties during gamma and e-beam sterilization.
At the end of the day, Fitzgibbons said Clariant is watching out for its clients' bottom lines, noting that it can cost "tens of thousands of dollars for customers to revalidate," a device if a supplier changes their formula.