8th Pharmaceutical Isolator User Group Conference
6th-8th December 2004 to be held at University of Warwick conference centre. The conference is designed for both those involved and those who are likely to become involved with Pharmaceutical Isolators. It will consist of a blend of plenary and interactive seminar sessions as well as an associated exhibition. Suppliers and manufacturers will provide valuable sources of information through discussions and comment

Draft Programme

Objectives
To provide an introductory session for users who are new to pharmaceutical isolators.
To provide a forum where current information on isolator technology will be described.
To discuss ways in which isolators may be used.
To provide an opportunity for delegates to resolve practical problems by discussion with others.
To promote membership of the User Group.
Key aspects of the new book 'Pharmaceutical Isolators'; the new 'Yellow Guide' will be discussed. Delegates will have an opportunity to hear presentations relating to topics described in the book and to discuss some of their recommendations.
To present a balanced view on product and operator contamination risks.

Organisation
Brian Midcalf, Isolator User Group Working Party Chairman together with the Isolator User Group Committee. Administration by the
School of Continuing Education’s Professional Lifelong Learning Unit, University of Leeds.

Format
A high profile conference with representatives from industry, manufacturers and hospital pharmacy, using a style of plenary and seminar sessions with opportunities for individuals, manufacturers, standards setters and users (large and small) to present their views and findings for the benefit of all delegates.

Plenary sessions
Seminar sessions
Poster sessions
Manufacturers’ exhibition
Merit Award

The length of the conference will be three days. The main session will start after registration on Monday, 6th December and will end on the afternoon of Wednesday 8th December. An introductory seminar will be held for beginners on the evening of Sunday, 5th December, to familiarise new entrants to the world of isolators with the general principles of design and use. The Conference will present views many aspects relating to isolators, together with ideas on the latest design considerations and practical results of monitoring and use of this type of containment technology.

Venue
The
University of Warwick is close to the city of Coventry with easy access to major road and rail networks and Bimingham International airport is easily accessible.

Sunday, 28th October 2001
18.00 – 19.00 Conference Registration and tea for delegates attending the Plenary Session on Sunday,5th December, 7pm - 8.30pm Isolators for Beginners
a refresher session to ensure familiarisation of basic Isolator technology for new users. An open forum discussion which highlights discussion topics for the conference. Brian Midcalf,
Lynn Carroll, David Morley, Pharmaceutical Isolator User Group Committee and industry representatives

Day 1:

Monday 6th December 2004
08.30 – 09.30 Conference Registration and coffee
Plenary Sessions

Introduction and Objectives Chairman - Brian Midcalf, University of Leeds Global view of the Isolation Technology world Jack Lysford, USA
Current developments with Isolators - an industry view -Tony Byrne, Organon (Ireland) Limited
Guide to the new 'Yellow Guide' - summary of key points Brian Midcalf, University of Leeds
Design, Construction and Materials for Isolators - Brian Bergin, Consultant Engineer
Sporicidal Gassing - how it can be achieved in practice - Ron Feakes, Baxter Healthcare Limited
Biological Indicators - Development group update and status -
Graham Steele, University of Luton
Overview of different gassing techniques, qualification of gassing Isolators - Jon Nottingham, Steris Limted
Isolation technology in small scale manufacturing. An industry case study - Bushrah Sajit, Dabur Oncology
The use of Isolators in a hospital manufacturing environment. A case study - Speaker to be confirmed

Day 2:

Tuesday 7th December 2004
Plenary Sessions

Industry Theme
Introduction to the day's sessions:
Alan Mills, Chairman of the Parenteral Society
Standards: ISO EN14644-7 Part 7 - current status Gordon Farquharson, Bovis Lend Lease
Selection and evaluation of a system, establishing a URS. Experience from an industry case study Brian Bergin, Consultant Engineer
Developing the URS - particular requirements for Isolators Ron Feakes, Baxter Healthcare Limited
Disinfectant standards - challenging the test method Graham Hill, ECHA Microbiology
Seminar Sessions in 4 parallel streams
Topics include: o Staff training - numerous aspects including case studies
o Radiopharmacy Seminar session - handling PET radionuclides
o What's new in radiopharmacy? Radiation protection vs product protection.
o New 'Yellow Guide' some detailed appraisal
o Significance of handling cytotoxic drugs
o Training - Universal broth test
o Cleaning and disinfection
o Vulnerability to contamination - gassed and non-gassed Isolators
o Establishing an Isolator leak classification in an NHS hospital o The use and abuse of carbon filters
o Survey on use of Isolators
o Practical glove changing with different types of cuff rings
o RF welding for plastics - a demonstration
Presenters will include:
Lynn Carroll, Tim Coles, Bev Ellis, Lynn Morrison, John Neiger, Bob Pringle, Karen Rossington, Sarah Ryan, Pharmaceutical Isolator User Group committee
Final seminar session: Manufacturers Gizmos -
 open session where manufacturers demonstrate some novel or innovative devices.
Conference Dinner

Day 3:

Wednesday 8th December

Assessment of risks in the performance and use of Isolators in the NHS Richard Bateman, Guys & St Thomas's Hospital
Relative merits of laminar flow and turbulent flow - reflection on recent discussions Brian Midcalf,
University of Leeds
Leak
testing for dummies! Tim Coles, GRC
Isolators in 2010 - a view to future use Brian Bergin, Consultant Engineer
Isolator Novel Uses & Innovations
Peter White, Nova Laboratories
Panel Discussion -
o Critical & important features in the use of Isolators
o Key topics of Product/Operator Protection; Positive/ Negative Isolators; Leak significance; Risk assessment; Training

Closing of Conference at lunchtime

Although the organisers are committed to the programme, unforeseen circumstances may make changes necessary

The FULL CONFERENCE RESIDENTIAL FEE is £665, NHS rate £570. The fee includes bed and breakfast on Monday and Tuesday evening, Conference Dinner, light refreshments and lunches from registration on Monday, 6th December to lunch on 8th December.. Accommodation can be reserved for Sunday night at an additional cost of £60. The FULL CONFERENCE NON-RESIDENTIAL FEE is £590 and  £495 for NHS Members. The fee does not include bed and breakfast accommodation or the Conference Dinner but includes refreshments and lunches from Monday 6th December to lunch on Wednesday 8th December. For non-residential members who wish to attend the Conference Dinner, a place can be reserved at an additional cost of £40. You can reserve a place on this conference by contacting: Sophie Harker for a booking form at the, Professional Lifelong Learning Unit, School of Continuing Education, University of Leeds, Springfield Mount, Leeds LS2 9NG tel 0113 343 3241/ 3235 fax 0113 343 3240 email s.armitage@leeds.ac.uk For enquires regarding accommodation please contact Sophie Harker on tel 0113 343 3241 fax 0113 343 3240 email s.c.harker@leeds.ac.uk

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