James L Drinkwater


James L Drinkwater
Head of Aseptic processing technologies & GMP compliance
F Ziel GmbH

Chairman and Joint leader of PHSS Bio-contamination
special interest group

PHSS - Pharmaceutical and Healthcare Sciences
Societyrincipal of Critical Systems Ltd





Presentation Nr 5

Isolator & RABS technology and the increasing role in contamination and cross contamination control

  • Increasing requirements for Barrier Separation technology and current regulatory expectations
  • Contamination control attributes of Isolators and RABS: Restricted Access barrier systems
  • Risk based background environments for barrier technology, Isolators and RABS in Aseptic processing
  • Combined Aseptic processing and containment for cross contamination control
  • Current development of transfer systems for material entry into Isolators and RABS



Presentation Nr 9

The Revision of EU GMP Annex 1 will impact all in sterile and non-sterile medicinal/ therapeutic product manufacture – the PHSS considerations on the impact of Annex 1 revision to the Pharmaceutical industry and related Healthcare sectors working to GMP


  • What are the most significant Annex 1 changes that have to most potential impact to the Pharma industry?
  • If new technologies and practices are encouraged how is this managed within the revised Annex 1?
  • What is expected from the new requirement for a Control strategy in Annex 1?
  • If QRM is reinforced how does this impact qualification and process operations?




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