Richard Denk

Senior Consultant Aseptic Processing & Containment at SKAN AG

Richard Denk has studied mechanical engineering and did examination on Experts of GMP, Qualification and Validation, Pharmaceutical Auditing, Pharmaceutical Engineering, Quality Control on the University of Applied Sciences in Albstadt/Sigmaringen Germany. Richard Denk is working at the company SKAN AG, headquartered in Allschwil CH in the position Senior Consultant Aseptic Processing & Containment.

Mr. Denk founded 12 years ago the expert Containment group CoP of the ISPE D / A / CH. The ISPE CoP Containment published the ISPE Containment Manual in September 2015. The ISPE Containment Manual does provide a full overview on Containment. Furthermore, Mr. Denk is author at Maas & Peither GMP Publishing on containment and hygienic design and one of the authors of the ISPE Oral Solid Dosage Baseline Guide Volume 2 and Volume 3 and published several PDA Scientific Documents for Preventing Cross Contamination and Cleaning Limits for non-product contact surfaces. Mr. Denk is Steering Committee Member of the ISPE CoP SPP, chair of the ISPE Special Interest Group SIG Future Robotics, ISPE European Program Committee Member and Member of the ISPE European Leadership Team. Mr. Denk has spent more than 20 years with the subject production of highly active / highly hazardous substances and has developed the containment pyramid.

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Title: Contamination and Cross Contamination Control during Aseptic Manufacturing

  • Highly Potent Aseptic Products and their GMP and Occupational Exposure Requirements
  • Contamination Control Strategy CCS and how they improve the Cross Contamination Prevention
  • How to design a high potent aseptic Filling Line.