This latest evolution of HVLD aims to achieve a high level of closed container integrity (CCI) assurance across the entire range of parenteral products.
This white paper explores the labelling requirements for medical devices in the United States, the European Union, and China. Each territory has its own particular set of regulations governing the labeling of medical devices, and while there are a certain amount of commonalities in each of the regulations, there are differences which necessitate care from global manufacturers when distributing products.
This method can be used to identify potential points of weakness in a film or seal during the manufacturing process by simulating circumstances whereby the material may burst during packaging and transport.
MDIs are designed to deliver precise/accurate and reproducible doses of the drug to the lungs or nose. Good performance is crucial as patients rely on their inhaler to deliver the required dose of medication at often crucial times.
The degree of stiffness of a blister pack will affect its effectiveness. Measuring the required force to push-through a blister pack is therefore necessary.
Falsified and counterfeit medicines are a chronic problem for the pharmaceutical sector, with a third of all shipments in the worst affected parts of the world estimated to contain fake medicines. Highly portable and often extremely valuable, medicines continue to be a favorite with those determined to fake products or subvert the system for illegitimate gain. Faced with this continued global threat, legislatures around the world are responding by tightening the supply chain to stamp out illicit goods.
The true extent of the counterfeiting is unknown, since no global study has ever been carried out, but according to WHO estimates, up to 15% of all medicines are counterfeit.