Aseptic Processing - Liquid Fills and Manufacturing at Clinical Trial Scale
Following the successful launch of PHSS Aseptic processing training courses 2009, PHSS brings 12 new Aseptic processing topics presented in two courses.
Part 1 is being kindly hosted at Becton Dickinson on 2nd March 2010 and Part 2 is at AstraZeneca Charnwood on 20th April 2010.
These courses consider key issues for regulatory compliance, operational challenges latest developments and practical guidance.
An accumulation of data is presented from a range of PHSS sources, presented by industry professionals considering pharmaceutical science applied to Aseptic processing.
The course is for all levels of personnel involved in Aseptic processing across the range of applications in Pharmaceutical and Biotechnology, including, research, Clinical trials, Pharmaceutical production, Bio-processing, Sterility / Bioburden testing and equipment manufacture (Isolators, RABS, Process equipment).
Not a course series to miss!
Developments in Aseptic processing
- Best practice Barrier technology
- Bio processing and containment
- Overview of new transfer technology
- Developments in Isolator technology
- Development of the PHSS RABS Monograph 15 - changes after regulatory review.
Small scale Aseptic processing in Clinical trials. Pharmacy and Regenerative/Cell Therapy Medicine.
- Isolator solutions
- Impact of continuous particle monitoring.
- Viral clearance in Bio-processing
- Sterilisation and Gaseous decontamination solutions, considering compatibilities.
- Disposable single use technologies.
Environment monitoring, impact of Annex 1 and development of ISO standards.
- Practical guidance on applying Annex 1.
- Undersatanding non viable particle monitoring.
- Understanding the differences between Classification and routine monitoring.
- Partical counter calibration challenges.
- Viable monitoring and development of ISO standard - New considerations.
Sterilty Testing
- Rapid Methods BD Bactec
- Consumables and media
Gaseous Decontamination of Cleanrooms, RABS, Isolators including indirect product contact parts.
- Gassing in Place - GIP for in-direct product contact parts.
- Development of Gaseous decontamination in process equipment, Freeze dryers, Autoclave 'cool cycles', process vessels.
- Leak testing and Leak finding.
- Glove integrity testing
- New PHSS technical monograph 17 -Pharmaceutical Isolators, RABS and Glove-Sleeve integrity testing and leak detection methods.
Venue
Part 1 - Being kindly hosted by Becton Dickinson, Oxford
Speakers
James Drinkwater, Chairman of PHSS, BioQuell UK Ltd
Tony Harrison, Vice Chairmand of PHSS, Hach-Lange Ltd
Application Manager, Becton Dickinson
Date
March 2, 2010
Enquiries
Please contact the PHSS Office for any further details
Costs
Member £ 300.00+ VAT
Non Member £ 400.00 + VAT
