Cleanroom Technology in the Field of Assisted Reproductive Technology (ART) is a highly debated topic. Regulated by the Medicines Act (AMG) and the Medicines and Active Substance Manufacturing Regulation (AMWHV), but not comparable to other tissues or even pharmaceutical manufacturing, the end user…

Qualified equipment, systems, and environmental conditions are fundamental in the manufacturing of pharmaceuticals and medical devices. They are a prerequisite for the validation of processes, procedures, methods, and systems. Through qualification, proof is provided that the used equipment, systems…

For now, 10 years, ValTec GmbH, based in Neuhausen am Rheinfall, Switzerland, has been successfully advising clients in the Life Science sector. Claudia Pachl has been working since the company's founding in 2006 until the end of 2014 as Head of Engineering on numerous projects for national and inte…

The ValTec GmbH is an expanding enterprise and works national as international as Dienstleister in the range qualification, validating and quality management for the pharmaceutical and chemical industry. Since newest the enterprise offers, with seat in Neuhausen at the case of Rhine (Switzerland), a…

Valide of processes and qualified equipment are a basic condition for GMP fair working in the adjusted surrounding field of the pharmaceutical and chemical industry. Around the legal requirements to fulfill and working on the current state of the art to gewaehreisten, founded expertise is necessary…