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.
Real-time release testing can be defined as a set of in-process controls that may provide greater assurance of product quality than end-product testing.
A platform’s integrated business framework helps dental implant and medical device manufacturer eliminate traditionally disconnected processes and data and increase the efficiency and accuracy of its product quality control.
With the importance of monitoring and verifying pressure conditions as well as humidity and temperature measurement data in its cleanrooms, this automation, management and monitoring solution offered a consistent solution for technical facility management and thus the prerequisite for cost-optimized plant operation.
Density measurement is a powerful and important method to ensure in-process control (IPC) and quality control of final products in pharmaceutical production facilities.
Anton Paar's Generation M density meters and Abbemat refractometers deliver accurate and repeatable measurement results while providing system security for 21 CFR Part 11 compliance.