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.
Designed and built to comply with and exceed FDA and GMP standards and to satisfy the demands of the pharmaceutical industry regulation, Pharma GF-PRO metal detection systems provide the ultimate in fully integrated product inspection and rejection systems for fine powders.
Designed and built to comply with and exceed FDA and GMP standards and to satisfy the demands of the pharmaceutical industry regulation, Tablex-PRO metal detection systems provide the ultimate in mobile, fully integrated product inspection and rejection systems for tablets and capsules.
The LyoCapsule Freeze Dryer is a lyophilization instrument that delivers results comparable to larger R&D freeze dryers enabling a Quality by Design (QbD) approach to cycle development even when materials are highly expensive or limited in quantity.
Reliability and transparency of production data are the basis of all planning. The EC-E checkweigher from WIPOTEC-OCS guarantees 100% data capture in ongoing production.
The EC-E-VA model has an innovative design with weigh cells, drives, and belt construction in stainless steel (protection class IP65) and is recommended for use in light to average humidity environments.
A practical addition to the ESSENTIAL series, the EC-E-SL is designed for high precision weighing of larger or heavier product formats.
The HygroClip2 ADVANCED humidity and temperature probes offer you maximum repeatability and an accuracy of ±0.8 %RH and ±0.1 K.
