For all manual processes – including the manual implementation of wiping procedures for larger surfaces – the question remains whether a process performed by humans can be reproduced and thus validated.

Validation refers to providing documented evidence that a process or system consistently meets the…

– Important milestone reached for the new site
– Additional filling capacities for early-stage clinical development
– First customer audits already completed

Vetter, a leading global Contract Development and Manufacturing Organization (CDMO), has received the manufacturing authorization for its new sit…

After 15 years of sustainable cooperation, Clestra Cleanroom and PPG Cleanroom have gone a step further joining forces to create a leading European company in the cleanroom area. To be able to provide a fast and quality response to the needs of a fast-growing international market is the reason behin…

Conserving resources is a central theme of our society. In this context, the development of many parts and components is moving towards using less material and smaller structures. Consequently, the components become more sensitive, increasing the requirements for part cleanliness to ensure flawless…

A German pharmaceutical company decided to build a new production facility based on the latest standards and pioneering technology. The existing production sites had primarily been focused on decontamination with formaldehyde and qualified accordingly. The specific requirement for the new building w…

Anyone who wants to use hydrogen as an energy source needs electrolysers. However, they are rare and expensive because they are still largely manufactured by hand. To enable mass production on an industrial scale in the future, a research team from Fraunhofer IPA is currently developing a fully auto…

The Dorfner Group can expand its collaboration with its client Biotest AG, which has been ongoing for eight years. The contract includes not only the maintenance cleaning of office and administrative spaces but also a large part of the cleaning of the cleanrooms. With the expansion on February 1, 20…

The antibacterial foam gasket RAKU® PUR 32-3294-2 by RAMPF Polymer Solutions has been certified to the latest standard DIN EN ISO 846 (11/2020). The two component polyurethane system is used in a range of applications, including AC systems, HVAC, control cabinets, lights, and lamps.

RAMPF Polymer Sol…

Introduction

The various GMP guidelines and International ISO standards around GMP cleanrooms are complex and often appear to give conflicting advice, leading to confusion and sometimes incorrect interpretation. In the case of Routine Environmental Monitoring, there is very little prescriptive advice…

The topic of digitalization is on everyone's lips and affects nearly all industrial sectors. As a specialist in cleanroom monitoring as well as remote maintenance and IIoT technologies, for more than a quarter of a century, the guiding principle of eurogard GmbH is more relevant than ever: Digitaliz…