FDA hopes pharmaceutical manufacturers will address packaging- and labeling- related errors before they even occur. Sound impossible? Not if you consider the agency’s interest in human factors engineering and its design control requirements for medical devices.
Clondalkin Group Holdings B.V., which produces secondary healthcare packaging among other offerings, has promoted David Lennon and Paddy Mullaney to serve as co-CEOs of the group and as members of Clondalkin’s Board of Directors.
SHL Medical is using specialty labeling on pen injectors and autoinjectors. The designer, developer, and manufacturer of drug-delivery devices supplies auto injectors, pen injectors, and inhaler systems to global pharmaceutical and biotech companies.
For SHL Medical’s DAI and Molly devices, Schreiner MediPharm, a Germany-based global provider of specialty pharmaceutical labeling solutions, developed customized sample labels for demonstration of the autoinjectors to pharmaceutical manufacturers.
FLEXcon Europe has been recognized with the New Product of the Year Award at the 2013 Scottish Business Awards for use as a component in Needle-Trap, a labeling solution from Schreiner MediPharm. The Product of the Year event in June featured former President Bill Clinton as the keynote speaker.
As the medical device industry begins to prepare for Unique Device Identification, FLEXcon has launched FLEXcon MedFLEX, a line of label substrates designed to meet FDA’s performance requirements. The FLEXcon MedFLEX line can support unique coding as well as comply with rub tests, the company reports. Specifically, the line is UL-certified in accordance with UL/IEC 60601-1 3rd edition marking durability rub tests, the company reports, and three of the products are UL-recognized with inks and ribbons.
A Swedish company specializing in medical-cosmetic products is making it harder for counterfeiters to copy its anti-wrinkle product, Restylane. Q-Med AB – wholly-owned by Galderma, a pharmaceutical company focusing exclusively on dermatology – protects the health of Chinese customers with a special security seal provided by Pharmapack North America exhibitor Schreiner MediPharm that bears an encrypted code and further counterfeit-protection features.
Packaging and labeling producer Clondalkin Group has promoted David Lennon, previously CEO of its European Pharmaceutical and Healthcare division, to serve as Global CEO of the division. Lennon is charged with expanding the mainly European and North American business into emerging markets as well as developing new products that help its customers address challenges surrounding patient safety and compliance and product counterfeiting. He will also oversee the use of new technology to drive ongoing improvements in quality and efficiency.