May the Force be with us!

Dr. Timo Krebsbach

Anyone fighting daily in cleanrooms against the dark side of the Force must be well equipped. But how? The newly published practical guide "Cleanroom in the Pharmaceutical Industry" provides the gear and spans from planning through qualification to the everyday use of cleanrooms, with a look into the future as well.

The Star Wars community knows and loves him—the exciting battle against the dark side of the Force. In the cleanroom community, you can also feel a bit like a Jedi Knight, because we too fight a dark power every day anew. This power is dark because it is invisible, unpredictable, perhaps even more troublesome... and numerically far superior. The "dark side" refers to microorganisms and particles. And precisely these hinder us in our mission of manufacturing or testing products in the cleanroom. Instead of laser swords, laser particle counters are used in the cleanroom, but on the bright side of the Force, other success factors also count:

- Plan: a well-thought-out concept based on regulatory requirements, keeping the state-of-the-art technology in view
- Knowledge: understanding and awareness of all relevant processes
- Will: the mental readiness that ensures flawless work in and around the cleanroom
- Implementation: victory over particles and microorganisms

The practical guide "Cleanroom in the Pharmaceutical Industry" offers concrete assistance on the following topics, but does not get lost in details:

- Regulatory requirements
- Contaminations
- Planning of cleanrooms
- Cleanroom clothing
- Cleanroom consumables
- Handling of consumables
- Cleaning and disinfection as part of the manufacturing process
- Monitoring in the cleanroom
- Purified water
- Measurement technology in the cleanroom
- Quality assurance
- Qualification and validation
- The cleanroom of the future
- Cleanroom versus clean room
- Outlook

The authors are all experienced "fighters" and mentors. In addition to the many years of experience and expertise they bring from their respective fields, each has an overview of the big picture. How important it is to see the connections, was accurately expressed by the "football professor" Dettmar Cramer: "Everything is connected somewhere. You can pluck a hair from your backside, and your eye will tear."

It is increasingly observed that the ability to see the overall context is becoming rarer, and this must be countered.

Written from practice for practice, this book is primarily aimed at

- the pharmaceutical industry
- the supply industry
- contract manufacturers (production and processing companies)
- users, operators, and planners of cleanroom technology
- equipment manufacturers and suppliers for cleanroom technology

It is an ideal mental preparation for the fight against the dark side. Enjoy reading and... may the Force be with us!

More info at:
https://www.ecv.de/Buecher/Reinraum_in_der_pharmazeutischen_Industrie

Publisher:
Dr. Timo Krebsbach

Authors:
Dr. Jürgen Blattner, Dr. Frank Böttcher; Prof. Dr. Gernod Dittel, Frank Duvernell, Dr. Timo Krebsbach, Carsten Moschner, Dietmar Pfennig, Dr. Markus Rochowicz, Prof. Dr. Christa Schröder, Dr. Frank Stieneker, Margarete Witt-Mäckel