Aseptic Processing Training Course - 20th April
ENHANCED PROGRAM
The increase in Aseptic Processing has brought into focus key areas of Barrier-Separation Technology, Contamination control, Environmental monitoring and the impact on process equipment.
This course continues to provide essential information at all scales of Aseptic processing, including; Production – Manufacturing, Sterility Test, Clinical Trials and Hospital Pharmacy Aseptic services.
The PHSS are also pleased to welcome the President of the PDA UK Chapter to present on Clinical Trials. Siegfried Schmitt is a Principle consultant of Parexel a leading company involved at all stages of Clinical trials.
Many new drugs require aseptic processing. The presentation will cover current needs for clinical trial materials. It ill also touch on the subject of scale-up and associated compliance issues.
AZ Aseptic Processing Training course: 20th April 2010
Barrier – Separation Technology – James Drinkwater, Chairman PHSS
• Selection criteria between Isolators and RABS, Restricted Access Barrier Systems.
• PHSS Monograph RABS type selection matrix.
• Final PHSS RABS Monograph draft, comments from the MHRA/FDA.
• Aseptic processing Interventions, Inherent and Corrective.
Potential Application Of A Real Time Microbial Detector IMD In Aseptic Process Joe Engle , BioVigilant Systems Inc.
This presentation discusses an optical instrument (IMD) for instantaneous detection of microbes in the environment.
The IMD instrument measures the intrinsic fluorescence from certain metabolites inside microbes to differentiate microbes from inert particles. Since the metabolites (e.g. NADH and riboflavin) responsible for the generation of this intrinsic fluorescence are present within the cells of microbes, this technique has a broad microbial detection range without the need for sample preparation.
The presenters will discuss the possibilities of using IMD instrument as a process analytical tool to demonstrate the control of an aseptic environment, to facilitate risk analyses and to help in the reduction of microbial contamination.
Process Transfers in Aseptic processing. James Drinkwater
• Sterile product Fluid-path transfer, options.
• Autoclaved product contact parts transfer to filling line, Aseptic process.
• Transfer of pre-sterilised packages/parts to Aseptic Grade A zones.
• Rapid transfer Port, Alpha-Beta door technology and connection options.
• Transfer of environmental monitoring and cleaning materials into Cleanrooms.
• Waste handling in Aseptic processing.
Clinical Trials – Siegfried Schmitt
• Overview of Current Clinical trials
• Cost Considerations
• Special Manufacturing requirements
• Aseptic small batch production.
Aseptic loading and unloading of Freeze Dryers. Joanne Broadhead, AZ Team leader Liquids Manufacturing and Dr Kevin Murgatroyd, Senior Pharmaceutical Consultant Scitech.
• Aseptic procedures during manual loading and unloading,
• Semi-auto solutions
• Automatic
Hydrogen peroxide vapour bio-decontamination Process and Materials Compatibilities. James Drinkwater.
• General and Sensitive materials
• Filling line fluid path compatibilities
• Product containers
• Sterility test materials
• Environmental monitoring equipment and materials.
• HEPA / Sterilising filters
• Optical devices, Cameras, Microscopes.
• Cleanroom wall systems and infrastructure
• Detergents and Disinfectants
Venue
Astrazeneca, Charnwood
Speakers
James Drinkwater - Chairman of PHSS, BioQuell UK Ltd
Joe Engle , BioVigilant Systems Inc.
Siegfried Schmitt, President of PDA UK
Joanne Broadhead, AZ Team leader Liquids Manufacturing
Dr Kevin Murgatroyd, Senior Pharmaceutical Consultant Scitech
Date
April 20, 2010
Enquiries
Please contact the PHSS Office for any questions.
Costs
Member £ 300.00+ VAT
Non Member £ 400.00 + VAT
