pharma club 2016

The pharma club aims to create a platform for exchanging knowledge, practical application tips, problems, and solutions related to hygiene in cleanrooms.

High demands in a complex environment

The requirements for ensuring hygiene standards are becoming increasingly stringent, the regular updates to the GMP guidelines are becoming more opaque, and the expectations of inspecting authorities and customers are becoming more specific. Operating a cleanroom according to EU-GMP Annex 1 or DIN EN ISO 14644-1 repeatedly presents those responsible with major challenges regarding particulate requirements. The cleanroom alone would reliably maintain these requirements through technical concepts such as ventilation systems and pressure cascades if they function flawlessly.

Quick and professional action is essential for complying with legal regulations. However, this also becomes an increasingly challenging task due to the multitude of detailed regulations.

What could be more helpful than knowing how others handle it? Exchanging ideas within the industry and learning from experts is more important than ever in this context.

Platform for exchanging knowledge and experience

The pharma club aims to give its participants the opportunity to exchange ideas with others from similar professional backgrounds during engaging technical presentations and practical workshops.

Experts with years of experience regarding hygiene requirements for manufacturing in cleanrooms from renowned companies will share their expertise with the participants. The participants themselves are also encouraged to share their experiences and questions, thereby enriching the network.

The event targets all companies producing in cleanrooms as well as related industries with comparable issues. The event is rounded off with a joint evening gathering, inviting continued exchange and networking.

This year's pharma club is titled "Cross-Contamination in the Pharmaceutical Environment." Bringing personnel and materials into the facility poses significant challenges related to particulate contamination. Additionally, these contaminants can also be microbial and capable of multiplying. Particulate and especially microbial contamination pose a significant risk to the cleanroom status and, consequently, to the products manufactured there. The primary source of microorganisms in the cleanroom is precisely here—due to inadequate hygiene during transfer into the cleanroom. Therefore, a key focus is also on transfer disinfection.