Regulatory Requirements

The regulatory requirements for Good Distribution Practice of medicines are a consistent continuation of the rules applied during the manufacturing of medicines for Good Manufacturing Practice. This represents another step towards the quality assurance of medicines and startin…

On March 22 and 23, 2017, the "Cleanrooms Today" specialist conference will take place again as part of the Pharma Forum at Schlosspark Mauerbach. Representatives of national and international pharmaceutical companies and industry experts will discuss the latest developments, innovations, and effici…

ABOUT VCCN

The Dutch Contamination Control Society (VCCN) was founded in 1988 for everyone involved in contamination control and the associated facilities. Through actual knowledge transfer and joint exchange of experiences, the VCCN continuously strives to optimize professionalism in contamination c…

The Swiss Society for Cleanroom Technology (SRRT, or Swiss Contamination Control · SwissCCS) is a non-profit organization with approximately 300 members from industry and private individuals, engaged in contamination control as well as in plant construction for all matters related to cleanrooms.

At la…

With the new Chapters 3 and 5 and Appendix 15 of the EU GMP Guide, a new era has begun for determining health-based limits for cleaning of multipurpose facilities. PDE, what to do? That was the key question answered for participants of the PTS Connect Webinar PDE Cleaning Validation on June 1, 2016…

The cleanroom is a central subject of teaching and research in the Faculty of Life Sciences at Hochschule Albstadt-Sigmaringen. This article demonstrates how the topic of cleanrooms is addressed in practical-oriented teaching and applied research. It particularly highlights the close cooperation wit…

Motivation

The cleanroom is a system that only functions effectively when considered as a whole, and its subsystems must be well coordinated. Especially in GMP-regulated environments, an interdisciplinary view of the cleanroom system throughout its entire lifecycle—from the planning phase to operat…

Unavoidable, but outdated and expensive. Cleanroom operators and staff are familiar with the problem. Cleanroom technology is continuously evolving. Adjustments that would increase efficiency are costly and time-consuming – for most, this is not an affordable option. Because if the cleanroom works…

Manual disinfection is a necessary and simultaneously difficult-to-validate process in cleanrooms. This is mainly due to the unpredictability of the human factor. Automatic disinfection of rooms can be a sensible alternative.

For producers of highly sensitive hygienic products such as pharmaceuticals…

On March 15 and 16, 2016, it will be that time again: The specialist conference "Cleanrooms" will take place at Schlosspark Mauerbach near Vienna.

Representatives from national and international pharmaceutical companies, experts, and authorities will exchange ideas on how to design cleanrooms safely…