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James Drinkwater will give two presentations at Tema Renrum 2023 – Read more about the presentations below

James L. Drinkwater

F Ziel GmbH and PHSS

James is the Head of Aseptic processing technologies and GMP compliance at F Ziel Germany. James has retired from the role as Chairman for the past 10 years and continues to be leader of the PHSS Aseptic Processing SIGs. James is also an active member of the PDA and ISPE. Having worked in Amersham UK now GE Healthcare this was followed by positions of Technical Director at Barrier technology companies and Process and Compliance Director at a Bio-decontamination company. James is a SME on Gaseous disinfection and surface sterilisation using Hydrogen peroxide vapour (VH 202) technologies together with associated biological indicators with contribution to the PDA technical report 51 on BIs for gaseous decontamination processes.

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James L. Drinkwater
James Drinkwater’s Presentation No. 1 (of 2)

Annex 1 Implementation and Outcomes of CCS Preparations
– Typical GMP Compliance Gaps and Solutions

With Annex 1 becoming effective in August the implementation challenges have become more evident with many not being compliant on the effective date, but gaps identified, and remediation plans implemented. Some remediation plans are still open because of lack of clarity or consensus how to become Annex 1 compliant.

This presentation will cover key topics that are ongoing challenges including:

  • Preparation of a CCS and development as a Live document
  • Less subjective risk assessments for compliance to ICH Q9(R1) QRM
  • Differences between open and closed barrier technologies; Isolators and RABS
  • Din bio-decontamination technologies – process understanding
  • Meeting the 1 metre sample length requirements for particle monitoring and RMM monitoring
  • Air flow visualization studies – best practices
  • Managing and monitoring open barrier door intrusions into RABS at set up and during rare open-door intervention during aseptic processing
  • Implementation of new technologies: alternative RMM and bio-decontamination efficacy challenges using EIs: enzyme indicators
James Drinkwater’s  Presentation No. 2 (of 2)

Material transfers between different GMP grades

There are two primary routes for contamination transfer into Cleanrooms: personnel and materials as carriers and spreaders.

More and more pre-sterilized packaged materials are entering into Cleanrooms that are difficult to manually disinfect. Material airlocks and personal airlocks are critical control points at GMP grade changes. Design of MALs between CNC and C are increasingly under scrutiny and new centralized MAL solutions that apply a sporicidal step early in material transfers are now being considered so simpler IPA wiping can be applied later in material transfers (less impact on individual Cleanroom design).

This presentation will cover Material Airlock design between different GMP grade changes and new centralized MAL concepts that apply automated validated bio decontamination processes.

These MAL concepts and material transfer practices should be documented as part of the CCS with consideration to being holistic and collectively effective:

  • Considering Material transfer between different grades:
  • Warehouse to CNC material transfers
    • CNC > D > C
    • C > B
    • B > A
  • Material transfer technologies not reliant on manual disinfection 
  • Centralized MAL concept with sporicidal step and material distribution via closed transfer totes that are subject to external manual disinfection at GMP grade change MALs.
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