PDA EU00180 Manage Your Isolator for Aseptic Processing

Richard Denk is working at the company SKAN AG, headquartered in Allschwil/Switzerland  in the position Senior Consultant Aseptic Processing & Containment. Richard was member of the PDA Isolator Expert Group and publisher of the PDA Paper “Isolator Surfaces and Contamination Risk to Personnel and Patient”. Furthermore, Richard is Member of the PDA Advisory Board for ATMPs, Richard is Member of the ISO TC 198 WG-9 Aseptic Isolator Group. Richard founded 15 years ago the Containment expert group of the ISPE D / A / CH. The Containment Group published the Containment Manual Richard was responsible for in September 2021 Richard has spent more than 30 years with the subject production of aseptic processing and highly active / highly hazardous substances and has developed the containment pyramid.

Andrew Hopkins has a BSC (Hons) in Microbiology with Genetics and a Post Graduate Diploma in Industrial Pharmaceutical Science. His has worked in the industry over 35 years.

Currently Andrew is a Director Microbiological Contamination Control the role includes Liaison with Engineering for key project designs, training and mentoring, guidance on the implementation of Annex 1 and interaction with regulatory agencies.

Prior to this, Andrew was an Inspector with the MHRA for nearly 14 years. This role included:

• Routine (and less routine!) inspections across the world, including joint inspections with a number of other regulators (USFDA, TGA, TFDA and Health Canada) in a number of technical areas including, sterile products, biological products, blood components and plasma.
• Chairperson of the Inspectorates Compliance Management Team (working with marginally compliant companies to support them back to full compliance)
• Part of the MHRAs inspection Action Group (taking actions regarding non-compliant sites)
• Inspector training and mentoring
• Taking part in the writing of regulatory guidance documents including:
  • MHRAs Data Integrity guidance
  • EMA guidance on water systems
  • Chair for the working group for the revision of Annex 1
  • MHRA blog regarding the fragility of VHP
• Supporting external industry bodies with technical monographs e.g. PDA TR1 and PHSS TM20.

Prior to joining the MHRA Andrew worked for more than 20 years in a number of different areas and technologies in the Pharmaceutical industry. These included QA, Validation and Production Management in both sterile and non-sterile manufacturing facilities.

Andreas Kindscher is Product Line Specialist at SKAN and works in the area of Glove Management. Since his successful master's degree in mechatronics, he has worked in various areas, but mainly in his current area - Glove Management.  In this area he focuses on glove testing, glove materials and the correct use of gloves and forms the bridge between development, product and users.

Tracy Moore is an accomplished quality professional with over 32-year experience of pharmaceutical manufacture, distribution and regulation gained from working within the industry and also for the GMP Inspectorate of the UK medicines regulator (MHRA) where she reached Expert Inspector level/status.

During her 10 years as a GMP Inspector Tracy had responsibility for licensing and inspection of pharmaceutical manufacturers and distributors both in the UK and overseas, the development and implementation of regulations and European guidelines relating to pharmaceutical manufacture and distribution, the management of risk and noncompliance in these sectors and collaboration with other European and International regulatory authorities.

Tracy set up the MHRA's inspector academy in 2020 which allowed for an efficient accreditation of MHRA inspectors and assessed Member States inspector's competence through the Joint Audit Programme for EU.

Prior to the MHRA, Tracy spent 22 years working in both commercial and R&D environments of the pharmaceutical industry in various QA, QP and management roles covering a wide range of sterile and non-sterile product dosage forms. In addition to this, she has been responsible for the audit and oversight of Contract Development and Manufacturing Organisations (CDMO), component suppliers, and API manufacturers. 

Richard Mühle is project manager at SKAN Deutschland GmbH, where Richard oversees customer projects relating to the Wireless Glove Tester up to qualification. He is responsible for further development and maintenance of the product as well as the organization and coordination of the associated peripheral areas, which includes gloves themselves. After a 6-month research stay at Universiti Teknologi Malaysia to the design of spinal implants, he completed the master degree for Biomedical Engineering at Technical University Ilmenau 2015 with focus on biosignal evaluation. In the last five years he worked as a research assistant at Technical University Dresden on several projects with topics relating to tumor detection during brain surgery and normothermic transplantation technology.