Föreläsare tema renrum

James L. Drinkwater

F Ziel GmbH and PHSS

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 Society

Read more about James two lectures below

James L. Drinkwater är tillbaka på Tema Renrum i år och håller i två presentationer – Läs om respektive föreläsning nedan

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James L. Drinkwater
James Drinkwater’s Föreläsning nr 1 (av 2)

PHSS Clarity on GMP Guidance initiative: Part 1: Cleanroom environments and their control.

New guidance documents are considered necessary to clarify regulatory expectations and provide key points to consider over and above generic GMP and in light of Annex 1 revision where QRM is a key consideration. PHSS Clarity on GMP guidance notes are in preparation for the following range of topics:
  1. Assurance of sterility in Aseptic manufacturing of surfaces that contact product contact parts e.g. Stopper bowl/ trackways indirect product contact parts
  2. Rationale for Environmental Classification, Qualification, Monitoring for Aseptic process filling applications with Barrier technology.
  3. Localized uni-directional airflow: L-UDAF as protection from airborne contamination transfer within a classified zone.
  4. Continuous particle monitoring in controlled areas including GMP compliance monitoring (at 1m3 sample volume) monitored in a 36 minute ‘walking window’ and contamination event monitoring (at 1ft3 sample volume)
  5. Risk assessment in setting EM Sample locations for monitoring during classification, qualification/ process simulations/ Media fills and during routine production operations.
  6. Airflow visualization of uni-directional airflow in GMP controlled zones including barrier systems considering CFD: computational fluid dynamics, Smoke visualization studies and LR Method (smoke particle challenge with tracking of particle movement via particle counting)
  7. Contamination control strategy. Rationale and points to consider in preparation of a Contamination Control Strategy: Annex 1 requirement.
  8. Aseptic Containment Strategy. Aseptic processing with containment because of process toxic or bio-hazardous products requires a strategy to balance the patient safety by protecting against bio-contamination and process operator safety
James Drinkwater’s  Föreläsning nr 2 (av 2)

PHSS Clarity on GMP Guidance initiative:
Part 2: Processing in Cleanrooms

  1. Media Fill design. The design of a Media fill program is challenging as it has to take account of inherent and corrective interventions, operator fatigue and campaigns. This rationale provides points to consider and provides recommendations on good practice.
  2. Gowning and Cleanroom Behaviour covering selection, gowning qualification and good practice in preparation for entering cleanrooms and behaviour in cleanrooms.
  3. No-Touch-Transfer: NTT of pre-sterilised containers into Barrier technology following GMP and QRM principles.
  4. Definitions of ‘Open and Closed’ applied to Aseptic processing. The terms Open and Closed are used across the Pharmaceutical industry for a variety of technologies and processing methods and are sometimes confused.
  5. Barrier Glove management strategy for Barrier system gloves-sleeves as a Life cycle including selection, integrity testing (visual and physical) and response to post batch glove leak detection.
  6. Avoiding Wet loads in Moist heat sterilization. Wet loads can be the result of a number of factors and guidance is required on points to consider.
  7. VHP/vH202 surface Bio-decontamination of loads in Barrier Isolator technology and Material transfer chambers including qualification studies with biological indicators (BIs) and requirements for correlation studies for enzyme indicators (EIs). This guidance covers loads that form part of an Isolator set-up for Filling operations and Material transfer VHP Bio-decon loads patterns for transfer into Barrier systems
  8. Barrier Leak rates and leak Integrity applied to Barrier systems relative to contamination risks in Aseptic processing and containment of hazards.
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