ISPE Conference on Product and Process Quality

Barrier Isolation Technology

Monday 15- Tuesday 16 September 2008
Manchester, United Kingdom

Seminar Leaders:
Jack Lysfjord, Lysfjord Consulting LLC (USA)
Charlotte Enghave, NNE Pharmaplan (Denmark)

• Technology updates from vendors on the latest technologies
• Case studies on recent implementations
• Discussion groups and industry comments

Through a successful formula of technology updates, case studies, discussion groups and industry comment, this seminar will present the latest developments in barrier isolation technology. Vendors will briefly introduce the latest and most innovative technologies, while case studies will focus on the implementation of recently developed isolators.

Offering a global perspective with speakers from Europe and USA, this seminar will present state-of-the-art advancements for use in developing and manufacturing pharmaceuticals utilising barrier isolation technology. Sessions will include sterile transfer, electron beam technology, clean-in-place applications, and a range of topics such as the influence of humidity on concentration and the decontamination trusses. It will give professionals working in this continually developing arena an excellent opportunity to stay ahead of the curve on current developing technology.

Take Back To Your Job:

• Insights into updated technologies applicable to advanced aseptic processing using barrier isolation technology
• Advice on what to do and what not to do from those who have done it before
• Gain valuable knowledge from peer discussion groups that will answer your own questions on barrier isolation technology issues
• Identify regulatory agency perspectives that will streamline your regulatory submission and approval process

Agenda

Monday, 15 September

10.00 - 10.10 Welcome and Introduction
Charlotte Enghave, NNE Pharmaplan, Denmark; Jack Lysfjord, Lysfjord Consulting LLC, USA

10.10 - 10.45 Technology Update 1: Isolators, History and Trends, 2008 Data
Jack Lysfjord, Lysfjord Consulting LLC, USA

Survey update of use of Isolators 2008 for Fill/Finish Applications
Comparison with 2006 and earlier data and trends from data

10.45 - 11.30 Technology Update 2: Sterile Transfer of Materials into an Isolator Filling Line Using a Novel Electron Beam Emitter
Scott Ross Advanced Electron Beam (USA)

Using electron beam emitter systems to disinfect pre-fillable syringe tubs entering a Grade A filling isolator
Extending the use of tubs and E-beam emitter systems, including packaging components and environmental monitoring plates
Using E-beams for in-line sterilisation of primary packaging components, including bottles, caps and web materials in aseptic filling operations.
Methodology for establishing Materials suitability for R-beam disinfection or sterilisation and evaluation and impact of mechanical properties on extractables/leechables.

11.30 - 12.15 Technology Update 3: Influence of Humidity, Hydrogen Peroxide Concentration and Condensation on Bio-Decontamination with Gaseous Hydrogen Peroxide
Johannes Rauschnabel Bosch, (Germany); Beatriz Unger-Bimczak, Bosh (Germany)

Scientific study on bio-decontamination with hydrogen peroxide vapour
Detailed results on influence of humidity and peroxide concentration
Role of micro-condensation
Impact of humidity and concentration on bio-decontamination of hidden surfaces
Review on temperature, orientation, materials aspects of biological inactivation

12.15 - 13.15 Lunch and Networking Break

13.15 - 14.00 Technology Update 4: Use of Foam to increase Residence Time and reduce Liquid Volume for Isolator CIP applications
Speaker to be confirmed

14.00 - 14.45 Case Studies 1: Improving the Efficiency of Filling in an Isolator
Charlotte Enghave, NNE Pharmaplan (Denmark)

Business case for implementing campaign filling in an isolator
Evaluation of "need to have" elements in a batch change over
Future improvements

14.45 - 15.30 Coffee and Networking Break

15.30 - 16.15 Case Study 2: Case Study of an Application of Clean In Place (CIP) Technology to an Isolator
Sally Rush, Seiberling Associates (USA)

Aseptic barriers design considerations for enhanced cleanability
Six barrier specific questions asked which impacted CIP Unit selection and CIP program definition
Integrating CIP design requirements with user requirements and fabricators during barrier design and fabrication
Project execution considerations which insured a successful barrier CIP project

16.15 - 17.00 Case Study 3: Continuous and Instantaneous Viable and Non-Viable Air Monitoring Using Optical Spectroscopy
Michael Miller, Eli Lilly (USA)

Understand the concepts of optical spectroscopy and how this platform can be used to detect viable and nonviable particles in air samples
The science behind the BioVigilant IMD-A technology and how the instrument operates
Early feasibility studies and resulting Data
Long-term Viable and Nonviable environmental monitoring data in classified areas including isolators

17.00 - 17.30 Questions and Answers Session – Chair’s Seminar Close, Day 1
Charlotte Enghave, NNE Pharmaplan (Denmark); Jack Lysfjord, Lysfjord Consulting LLC (USA)

17.30 – 18.30 Networking Reception

Tuesday, 16 September 2008

09.00 - 09.10 Recap of Day 1 - Introduction of Day 2
Charlotte Enghave, NNE Pharmaplan (Denmark); Jack Lysfjord, Lysfjord Consulting LLC (USA)

09.10 - 09.55 Case Study 4: Utilising E-Beam Material Transfer into an Isolator Syringe Filling Line
Oliver Vogt, Hospira (USA)

Syringe manufacturing line objectives
Equipment/technology selection
E-beam system considerations
Conclusion/recommendations

09.55 - 10.40 Coffee and Networking Break

10.40 - 11.25 Case Study5: Filling Line Isolator with E-Beam for Pre-Filled Syringes
André Boesiger, Skan (Switzerland)

Overview & decision making process
Project planning & engineering
Isolator and E-beam design features
Customer experience
Validation

11.25 - 12.10 Case Study 6: Title to be confirmed
Bernd Sennhenn, Abbott (tbc)

12.10 - 13.30 Lunch and Networking Break

13.30 - 14.45 Discussion Groups

14.45 - 15.30 Coffee and Networking Break

15.30 - 16.00 Discussion Group Presentations
Speaker to be confirmed

16.00 - 16.30 Agency Comments

16.30 - 17.00 Questions and Answers Session - Chair’s Seminar Close
Charlotte Enghave, NNE Pharmaplan (Denmark); Jack Lysfjord, Lysfjord Consulting LLC (USA)


Conference Programme General Information Hotel Information Networking Evening Sponsorship Opportunities Table Top Exhibitions Download Brochure	ISPE Conference on Product and Process Quality Barrier Isolation Technology Monday 15- Tuesday 16 September 2008 Manchester, United Kingdom Seminar Leaders: Jack Lysfjord, Lysfjord Consulting LLC (USA) Charlotte Enghave, NNE Pharmaplan (Denmark) • Technology updates from vendors on the latest technologies • Case studies on recent implementations • Discussion groups and industry comments Through a successful formula of technology updates, case studies, discussion groups and industry comment, this seminar will present the latest developments in barrier isolation technology. Vendors will briefly introduce the latest and most innovative technologies, while case studies will focus on the implementation of recently developed isolators. Offering a global perspective with speakers from Europe and USA, this seminar will present state-of-the-art advancements for use in developing and manufacturing pharmaceuticals utilising barrier isolation technology. Sessions will include sterile transfer, electron beam technology, clean-in-place applications, and a range of topics such as the influence of humidity on concentration and the decontamination trusses. It will give professionals working in this continually developing arena an excellent opportunity to stay ahead of the curve on current developing technology. Take Back To Your Job: • Insights into updated technologies applicable to advanced aseptic processing using barrier isolation technology • Advice on what to do and what not to do from those who have done it before • Gain valuable knowledge from peer discussion groups that will answer your own questions on barrier isolation technology issues • Identify regulatory agency perspectives that will streamline your regulatory submission and approval process Agenda Monday, 15 September 10.00 - 10.10 Welcome and Introduction Charlotte Enghave, NNE Pharmaplan, Denmark; Jack Lysfjord, Lysfjord Consulting LLC, USA 10.10 - 10.45 Technology Update 1: Isolators, History and Trends, 2008 Data Jack Lysfjord, Lysfjord Consulting LLC, USA Survey update of use of Isolators 2008 for Fill/Finish Applications Comparison with 2006 and earlier data and trends from data 10.45 - 11.30 Technology Update 2: Sterile Transfer of Materials into an Isolator Filling Line Using a Novel Electron Beam Emitter Scott Ross Advanced Electron Beam (USA) Using electron beam emitter systems to disinfect pre-fillable syringe tubs entering a Grade A filling isolator Extending the use of tubs and E-beam emitter systems, including packaging components and environmental monitoring plates Using E-beams for in-line sterilisation of primary packaging components, including bottles, caps and web materials in aseptic filling operations. Methodology for establishing Materials suitability for R-beam disinfection or sterilisation and evaluation and impact of mechanical properties on extractables/leechables. 11.30 - 12.15 Technology Update 3: Influence of Humidity, Hydrogen Peroxide Concentration and Condensation on Bio-Decontamination with Gaseous Hydrogen Peroxide Johannes Rauschnabel Bosch, (Germany); Beatriz Unger-Bimczak, Bosh (Germany) Scientific study on bio-decontamination with hydrogen peroxide vapour Detailed results on influence of humidity and peroxide concentration Role of micro-condensation Impact of humidity and concentration on bio-decontamination of hidden surfaces Review on temperature, orientation, materials aspects of biological inactivation 12.15 - 13.15 Lunch and Networking Break 13.15 - 14.00 Technology Update 4: Use of Foam to increase Residence Time and reduce Liquid Volume for Isolator CIP applications Speaker to be confirmed 14.00 - 14.45 Case Studies 1: Improving the Efficiency of Filling in an Isolator Charlotte Enghave, NNE Pharmaplan (Denmark) Business case for implementing campaign filling in an isolator Evaluation of "need to have" elements in a batch change over Future improvements 14.45 - 15.30 Coffee and Networking Break 15.30 - 16.15 Case Study 2: Case Study of an Application of Clean In Place (CIP) Technology to an Isolator Sally Rush, Seiberling Associates (USA) Aseptic barriers design considerations for enhanced cleanability Six barrier specific questions asked which impacted CIP Unit selection and CIP program definition Integrating CIP design requirements with user requirements and fabricators during barrier design and fabrication Project execution considerations which insured a successful barrier CIP project 16.15 - 17.00 Case Study 3: Continuous and Instantaneous Viable and Non-Viable Air Monitoring Using Optical Spectroscopy Michael Miller, Eli Lilly (USA) Understand the concepts of optical spectroscopy and how this platform can be used to detect viable and nonviable particles in air samples The science behind the BioVigilant IMD-A technology and how the instrument operates Early feasibility studies and resulting Data Long-term Viable and Nonviable environmental monitoring data in classified areas including isolators 17.00 - 17.30 Questions and Answers Session – Chair’s Seminar Close, Day 1 Charlotte Enghave, NNE Pharmaplan (Denmark); Jack Lysfjord, Lysfjord Consulting LLC (USA) 17.30 – 18.30 Networking Reception Tuesday, 16 September 2008 09.00 - 09.10 Recap of Day 1 - Introduction of Day 2 Charlotte Enghave, NNE Pharmaplan (Denmark); Jack Lysfjord, Lysfjord Consulting LLC (USA) 09.10 - 09.55 Case Study 4: Utilising E-Beam Material Transfer into an Isolator Syringe Filling Line Oliver Vogt, Hospira (USA) Syringe manufacturing line objectives Equipment/technology selection E-beam system considerations Conclusion/recommendations 09.55 - 10.40 Coffee and Networking Break 10.40 - 11.25 Case Study5: Filling Line Isolator with E-Beam for Pre-Filled Syringes André Boesiger, Skan (Switzerland) Overview & decision making process Project planning & engineering Isolator and E-beam design features Customer experience Validation 11.25 - 12.10 Case Study 6: Title to be confirmed Bernd Sennhenn, Abbott (tbc) 12.10 - 13.30 Lunch and Networking Break 13.30 - 14.45 Discussion Groups 14.45 - 15.30 Coffee and Networking Break 15.30 - 16.00 Discussion Group Presentations Speaker to be confirmed 16.00 - 16.30 Agency Comments 16.30 - 17.00 Questions and Answers Session - Chair’s Seminar Close Charlotte Enghave, NNE Pharmaplan (Denmark); Jack Lysfjord, Lysfjord Consulting LLC (USA)