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View Track: Manufacturing
Manufacturing
Wednesday, March 26, 2008
M-1: Disposable Containment Technologies for Bulk Solids 9:00AM - 10:00AM (Wednesday, March 26, 2008)
Flexible disposable technologies become more and more important regarding the cleaning and containment. This presentation shows possibilities and solutions about the integration of flexible disposable technologies in new and already existing plants. Additionally it is pointed out that flexible disposable technologies can reduce production costs pending upon optimal planning. Case studies for the API and Pharma will be presented.
Richard Denk - Director of Pharma department, HECHT Anlagenbau GmbH
M-2: Pitstops for Your Process 10:15AM - 11:15AM (Wednesday, March 26, 2008)
Pitstops for your process NASCAR and Formula 1 teams know that "If you ain't running, you ain't racing". They focus on making their pitstops as quick and effective as possible. In manufacturing one might translate this as "If you ain't producing, you ain't profiting". Changeovers, including cleaning, sometimes take as long as 30-40 hours to complete. This presentation will show how to convert changeovers into pitstops. Using ESEE principles, it will show how to Eliminate, Simplify and Externalize Exactly! to reduce changeover times by 50% or more while improving the quality of the changeover. This presentation will be useful to anyone involved in changeover of manufacturing or packaging processes. Attendees will take away a methodology for identifying improvement opportunities. They will also take away a number of practical examples and tips that can be applied in their plants.
M-5: Ensuring the Safety Of Platinum Cured Silicones in the Manufacturing Process 10:15AM - 11:15AM (Wednesday, March 26, 2008)
Presentation of new research results about the risks of cytotoxic extractables generated in the pharmaceutical manufacturing process leaching into finished product.
Speaker:
Mark Rawet - Tubing Business Manager, Watson-Marlow Bredel Pumps
M-6: Bulletproofing Your Pharmaceutical Manufacturing Process: How to Rapidly Find Problems and Fix Them Right the First Time 2:00PM - 3:00PM (Wednesday, March 26, 2008)
When Bristol Myers Squibb was faced with frequent Quality Events at its Mayaguez, Puerto Rico facility, discovering the root cause of the problems often involved trial and error problem solving methods – and a good deal of wasted time and resources. After hiring consulting firm Kepner-Tregoe, Inc. (KT), Bristol Myers Squibb implemented the KT problem solving and analysis methodology as part of its Quality Events Investigation Process. Over the span of the first five months of implementation, 53 employees were trained in the KT methodology. The results were impressive: • Quality Events have been reduced by 25% compared with 1QTR 2006 • Investigation closings have been reduced by 7% compared to 2006YTD • All Quality Events have been investigated using KT principles • Investigation teams are more focused, disciplined, and confident in using the problem solving tools in their investigations • KT implementation has given an increased level of exposure and leadership to employees who have facilitated KT sessions
Speaker:
Michael Curran-Hays - Global Vice President, General Enterprise Practice, Kepner-Tregoe, Inc.
M-3: Efficient Material Handling is the Key to 'Lean Manufacturing' 2:00PM - 3:00PM (Wednesday, March 26, 2008)
Large Multinational Pharmaceutical companies are now faced with a business dilemma, with diminishing pipelines of blockbuster drugs and at the same time facing increasing competition from the international Generics industry in general and from Asia in particular, who are now producing good quality products at much lower costs. The pharmaceutical industry has always been grossly inefficient from a productivity perspective. It is too reliant on labour-intensive operations and spends more time cleaning than producing! This "cost" has previously been justified in the apparent pursuit of cGMP and quality, and in previous years of large profits – was not seen as a cause for concern. Now there is a need to minimise production costs and maximise production rates – "lowest cost per kg". Many multi-national drug companies are now looking at "lean manufacturing" philosophies, as developed by high volume industries with flexible production requirements, to achieve this. Lean terminology like "manufacture to order", "pull production "value stream mapping" are beginning to appear. However, Lean Manufacture is based on a removing the "7 deadly sins" of waste, which is more about efficient materials handling and logistics than it is on efficient processing. It is on this topic of materials handling that the pharmaceutical industry has a lot to learn (there has always been a focus on process). This presentation will discuss and compare potential new trends in the industry:- Continuous, Semi-continuous or Batch processing; Manufacture to Order or Campaign Manufacture; Solids Handling issues – guaranteed flow, control of flow, no bridging, venting displaced air, segregation of blended solids, degradation of tablets; continuous monitoring/PAT; Processing Efficiencies – Direct compression, Dry granulation, Wet granulation.
David Drew - Group Pharmaceutical Director, Matcon Ltd
M-4: Manufacturing Productivity Improvements Utilizing the Design Space and Process Analytical Technology (PAT) Concepts 3:15PM - 4:15PM (Wednesday, March 26, 2008)
This presentation will review the Design Space and PAT concepts and then will provide tangible examples of productivity improvements utilizing these concepts. Particular emphasis will be given to examples of improving productivity in biotechnology active pharmaceutical ingredient (API) processes. However, the basic concepts can be adapted to a wide range of manufacturing operations.
Speaker:
Fred Larimore - Director of Scientific Affairs, Cook Pharmica
Thursday, March 27, 2008
M-7: Lean Enterprise: A Business Model that Drives Success 9:00AM - 10:00AM (Thursday, March 27, 2008)
In the 1990's Baxter began implementing Lean Manufacturing principles in its manufacturing plants. See how this organization benefited from its early Lean implementations and some of the lessons they have learned over the past decade. Learn about the benefits of transforming Lean from a tool to a business model. Discover the opportunities created by dropping the term Lean Manufacturing and creating a Lean Enterprise.
Speaker:
Tony Johnson - Plant Manager, Baxter Healthcare Company
M-11: The Change from Fixed to Disposable: Discover Process Improvement Opportunities through a LEAN Six Sigma Lens 9:00AM - 10:00AM (Thursday, March 27, 2008)
Formal operational excellence initiatives and processes such as Lean & Six Sigma are gaining more widespread acceptance and implementation in biopharmaceutical manufacturing. Likewise some vendors of enabling technologies and equipment are applying the same methodologies to improve the quality and efficiency of their product and service offerings. We will explore the multifunctional endeavor of LEAN Six Sigma at GE focusing on the mistakes made along the way, and the return to employee involvement in complement to technologies. We will discuss the fundamentals of LEAN in detail and walk through case studies on LEAN implementations in bio manufacturing environments. A special focus will be given analyzing how the implementation of increasingly available ready to use, single use or disposable technologies enable LEAN manufacturing strategies resulting in greater speed flexibility and overall process agility in bio manufacturing operations.
Speaker:
Victor Bornsztejn - Global Growth Director, GE Healthcare, Life Sciences Service
Gerard Gach - Global Product Platform Director , GE Healthcare
M-8: Analysis of Particle Size and Distribution in a CFC-free Aerosol Based Pharmaceutical Preparation 10:15AM - 11:15AM (Thursday, March 27, 2008)
Several medications used to treat respiratory diseases are delivered in powdered form. Particle size and distribution are critical parameters for demonstrating the efficacy for these drugs. Robust analytical procedures and instrumentation are required to ensure reproducible and cost-effective particle size and distribution test results. IVAX Pharmaceuticals in Ireland has expanded its particle size and distribution analyses for its product, QVAR. (Medication details below.) Until recently, an outside laboratory in the U.K. had conducted drug particle size and distribution analyses for IVAX. Given the increased sample volume coupled with a need for more timely receipt of test results, IVAX chose to conduct this testing in-house. IVAX purchased a liquid particle counter to conduct their particle size and distribution analyses. This paper will focus on IVAX's evaluation to opt for in-house testing as a cost-effective, reproducible method for assessing drug quality via particle size and distribution. We will present the final methodology selected by IVAX to ensure quality and cost effective particle counting analyses. QVAR, is a maintenance medicine used to reduce the frequency and severity of asthma attacks. It is currently the only CFC-free (free of the chlorofluorocarbons) aerosol corticosteroid for the treatment of asthma in the U.S. QVAR delivers the smallest medication particle size, 1.1 microns, of any drug in its category. This smaller particle size allows for greater lung deposition in the smallest airways of the lung.
Joseph Gecsey, Jr. - Life Sciences Business Development Manager, Hach Ultra Analytics
M-12: Syringe Processing, from Filling through Packaging 10:15AM - 11:15AM (Thursday, March 27, 2008)
All aspects of Syringe Processing will be discussed, from E-Beam sterilization through filling, laser marking, inspection, labeling and packaging. Recent case studies will be presented on different line and equipment options.
Nancy St Laurent - Sr. Supervisory Process Engineer, Parsons Corporation
M-9: Blastoff: Best Practices & Lessons Learned for Successful Commercial Launch 2:00PM - 3:00PM (Thursday, March 27, 2008)
Launching a commercial product represents the penultimate event for a biotechnology or pharmaceutical company. However, there are considerable challenges in transitioning products from R&D to commercial excellence. Executing a successful launch program depends upon coordinating and bridging knowledge across virtually all corporate functions to effectively plan, organize, consider alternatives, reach consensus and ensure consistent communication and direction. This workshop will outline and discuss the commercial launch process and share insights and lessons learned from recent launches at companies including: LAUNCH TIMEFRAMES: Appropriate timing and critical time lines CROSS FUNCTIONAL APPROACH: How to engage the organization for launch and best organizational models for a launch team PARTNER SELECTION: Criteria to select effective manufacturing, packaging and distribution partners MULTI-YEAR BUDGETING: Cost to launch a new product and planning and budgeting for a multi-year launch effort CRITICAL NEW SKILLS & INFRASTRUCTURE: New people, processes and information systems needed to support a commercial launch.
Speaker:
Joan Bramer - Director, Commercial Launch Services, Maxiom Group
Andrew Komjathy - Vice President, Commercial Operations, North America, Shire Human Genetic Therapies
M-13: New Development in Hydrogen Peroxide Vapor (HPV) Decontamination of Rooms, Facilities, Isolators, and Various Pharmaceutical/Bio-tech Applications 2:00PM - 3:00PM (Thursday, March 27, 2008)
This is a summary presentation highlighting the recent advantages in bio-decontamination using Hydrogen Peroxide Vapor (HPV) technology on rooms, isolators, facilities, and various pieces of laboratory equipment. The major advantages of this process, and why many people will be interested, are: 1) Residue Free and No Secondary wipe down 2) Ability to execute decontamination in ambient room conditions without affecting temperature/relative humidity 3) Minimal Material Compatibility Issues and very effective on computers, microscopes, and precise electronic equipment 4) Efficacy against a wide range of organisms such as bacillus spores, mold, parvo virus, anthrax, tuberculosis, etc. 5) Validation/Verification of process using biological indicators 6) Limited Environmental Health & Safety concerns
Adam Warner - East Coast Sales Manager, BIOQUELL,Inc.
Speaker:
Kevin Trottier - Associate Director, Facilities & Engineering, Avant Immunotherapeutics, Inc.
M-10: Enteric Coatings, Review and Advances 3:15PM - 4:15PM (Thursday, March 27, 2008)
There have been significant advances in enteric coatings over the past 10 years, from tablet core engineering to subcoat considerations, to ingredient selection, processing equipment and controls. Processes once cumbersome and trouble prone can now be completed with simplicity and high confidence of success. Required weight gains can now be greatly reduced. Color can be incorporated in one coating step. New techniques can be applied to both aqueous and solvent coating, on both tablets and capsules, and in using both coating pan and fluid bed applications.
Stephen Levine - Group Leader, Scientific Affairs, Emerson Resources, Inc.
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