Richard Denk

Richard Denk has been working in the areas of hygienic design, containment and the production of highly active substances for over 20 years. He has been head of the containment group for the production of highly active substances since 2014. He developed the Containment Pyramid and founded the Containment Expert Group of the ISPE DACH. Furthermore he was the initiator and responsible for the ISPE Containment Handbook published in 2015.

After finishing his Mechanical Engineering studies, Richard Denk developed and headed up the Containment and Pharma/Life Science divisions at Hecht Technologie from 1994 to 2007. He was the Head of Sales there until 2014. Richard Denk founded the Containment Expert Group of the ISPE D/A/CH in 2008. In September 2014, the group published the Containment Handbook (German). He is also one of the authors of the ISPE Oral Solid Dosage Baseline Guide and organises training courses on the production of highly active and highly hazardous substances.

Richard Denk is involved in numerous expert committees and working groups: He is founder of the ISPE Special Interest Group 'Robots/Cobots in Pharma'. He is a member of the ISPE ATMP (Advanced Therapy Medicinal Products) Expert Group, the ISO TC 198 Sterilization and Health Care Products and the ISPE Community of Practice for Sterile Product Processing.

He is involved in the ISPE Program Committee for Biopharmaceutical and Aseptic Production and in the PDA Program Committee for ATMPs and Biopharmaceutical Production.

In addition, Richard Denk gives lectures on the topic of aseptic production, cell and gene therapy, containment, robotics, cleaning and hygienic design.

He is author or co-author of the following chapters of GMP Compliance Adviser:

4.C Hygienic Design
4.I Containment (personnel protection) for APIs, solid oral dosage forms and bio‑pharmaceutical products

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