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View Track: Facilities & Engineering
Facilities & Engineering
Wednesday, March 26, 2008
F-4: Hot Topics in Pharmaceutical Containment 9:00AM - 10:00AM (Wednesday, March 26, 2008)
In recent years the understanding of the containment of potent pharmaceutical containment has developed rapidly.
This presentation provides answers; in the form of examples, case studies and scenarios, to the current containment “hot topics”:-
• How to carry out a risk based approach to containment selection?
A proven, systematic risk based approach is presented along with examples of where it has been used for lab, primary (API) and secondary facilities.
This approach is used to systematically identify containment issues on existing and new plants and at the design stage. These containment issues cover:- • Normal operation, • Support activities such as equipment cleaning • Non-operational activities such as planned maintenance • Unplanned/infrequent operations such as breaking out contaminated equipment. • Fault and emergency conditions
The methodology includes:-
• Risk based methods to identify the activities and operations that pose the biggest risk of operator exposure. • Using the two basic containment principles to achieve cost effective, layered turn-up/turn-down containment • How the final choice of containment solution is rarely selected on containment performance alone.
• Do vendor guarantees and performance testing ensure adequate containment?
Containment equipment is typically purchased against a vendors guarantee that testing has shown it can achieve the containment performance required by the customer. This presentation gives real example of how to maintain as-new performance from containment systems and examples of how far containment performance can fall if this is not done.
• Are dedicated high potency facilities really required to control the cross contamination risk?
The potential risks of product cross contamination from high potency products have frequently led these products being manufactured in dedicated or segregated facilities. The ISPE RiskMAPP document aims to address the question of whether this is necessary or whether a rational, risk based approach can be used to justify the decision of whether to dedicate or not. In this presentation, case studies and scenarios are presented that quantify the cross contamination risk and illustrate the types of facility that represent the highest risk.
• How to minimise the environmental impact of high containment facilities?
High containment facilities are designed to provide a tightly controlled environment and all routes for people, material, products, waste and ventilation into and out of that environment are similarly tightly controlled. This presentation gives examples and case studies of how this tight control can be achieved without excessive energy consumption.
F-1: Turning Green into Gold - CANCELLED 9:00AM - 10:00AM (Wednesday, March 26, 2008)
Companies have a great opportunity to turn pressure to operate in an environmenatlly sustainable manner into profit. Not only can they make cost savings from energy and materials/ waste reduction programmes, companies can use sustainability as a competitive leaver to increase market share. This session will examine how turning 'green into gold'requires a deep understanding of commercial cost / benefit versus environmental impacts across the end to end supply chain. Examples from pharmaceuticals and other sectors such as consumer products will be used to illustrate how a true understanding of the sweet spot between product and process requirements, technical feasibility and commercial reality can lead to increase in profit and improvement of our world - CANCELLED
F-5: How to Gain a Competitive Edge Through Process Understanding 10:15AM - 11:15AM (Wednesday, March 26, 2008)
This session will highlight a proven approach and methodologies to ‘process understanding’ as an essential component of a successful manufacturing strategy. It will include a series of practical case study examples that will highlight the specific tools and techniques that have been applied successfully by leading global Pharma/Fine Chemical companies to deliver substantial business benefits in excess of US $200 million. It will also focus on the value and benefits of process understanding as a mechanism for companies to be able to respond positively to the changing and increasingly stringent demands of regulators in the pharmaceutical manufacturing environment.
Speaker:
Prabir Basu, PhD - Executive Director, National Institute for Pharmaceutical Technology and Education (NIPTE)
F-2: Integrating Clean Power that Saves Maintenance, Space and the Environment 10:15AM - 11:15AM (Wednesday, March 26, 2008)
Facility reliance on battery-based UPS systems is falling out of favor with the advent of more reliable forms of back-up power. Costly and frequent maintenance/replacement, spotty reliability, expensive HVAC requirements, fire hazards, spill containment, personnel health and safety hazards, excessive space demands, floor loading and environmental impact leave a lot to be desired. Flywheel power protection systems -- a technology that's been around for some time -- has now reached true commercial viability, solving the problems challenging facilities everyday. The latest generation flywheel systems “harden” battery arrays by protecting them from virtually all usage. Facilities are elimating their battery headaches altogethe by using flywheels to directly bridge to generators. This presentation provides examples and examines how and why modern UPS flywheel systems are delivering better energy, space, environmental and cost advantages over problematic battery-based systems.
Speaker:
Johnny Gonzales - Vice President Sales & Services, Pentadyne Power Corporation
F-3: Energy Prices Have Changed Everything & What the Heck is Sustainability? 2:00PM - 3:00PM (Wednesday, March 26, 2008)
The game has changed. The major increase in the cost of energy in the last few years has caused decisions made as little as three years ago to now be incorrect. In addition, the national yearning for “green” and “sustainability” and the response from major corporations and some states, not to mention the international community, have created a need and opportunity for action. But what actions, and what the heck is sustainability? This paper will start from the beginning, defining sustainability, and carry through to what it means for the corporations in this industry. More importantly it will identify opportunities for reducing greenhouse gases (air emissions), reducing energy consumption, and increasing the bottom line. The opportunities to be presented will cover air and water pollution control, site remediation, manufacturing/processing, waste management, and buildings; and the audience will experience a practical summary of sustainability and green that will stimulate ideas to explore in their individual areas of responsibility.
Richard Toro - Director, Environmental Services, Brown and Caldwell
F-6: WORKSHOP: A Cost Reduction Case Study of a Potent Compound Aseptic Filling Line 2:00PM - 4:00PM (Wednesday, March 26, 2008)
Session will present case studies of sterile fill finish facility layouts. Both traditional Grade A and Grade B areas will be compared with modifications that can be acheived with isolator technology. Facility and equipment design differences associated with handling both potent and non-potent compounds will be discussed. The design consideration for containment, cross contamination, and aseptic design will be discussed.
Speaker:
Stephen Errico - Director, Facilities Management & Engineering, Eisai, Inc.
Christa Myers - Chemical Process Engineer, CRB Consulting Engineers
David Ross - Project Manager, Yonkers Industries, Inc.
Thursday, March 27, 2008
F-7: WORKSHOP: Critical Utilities Case Studies: What Went Right, What Went Wrong! 9:00AM - 11:00AM (Thursday, March 27, 2008)
Various Operating companies, Consultants and Suppliers will present case studies on critical utilities. Each case study will examine a project and discuss lessons learned. Critical Utilities examined will include; WFI, Pure Steam, CIP/SIP.
Peter Vishton - Technology Engineer Pharma Water Systems, Wyeth
F-8: Key Considerations in Bioprocess Facility Fit 2:00PM - 3:00PM (Thursday, March 27, 2008)
A critical step in the development of a biopharmaceutical manufacturing process is the determination of process-facility fit. This involves evaluating whether a process may be economically carried out in a given facility. Some of the key considerations include the size and type of primary processing equipment, the availability and size of supporting equipment including media and buffer tanks and CIP skids, and utilities including especially purified water. Less tangible factors, such as worker productivity, may also play a role. This presentation will cover the key calculations that need to be made along with software that can speed the evaluation process. The calculations and techniques are illustrated by a case study in which two possible plants are compared for a monoclonal antibody process.
Charles Siletti - Director, Scheduling & Planning Applications, Intelligen, Inc.
F-9: Steps for Performing a Successful Facility Decontamination 3:15PM - 4:15PM (Thursday, March 27, 2008)
This presentation will start at the beginning of the process with general cleaning requirements to prepare the area for fumigation. It will then describe the three primary methods which are formaldehyde, hydrogen peroxide vapor, and gaseous chlorine dioxide. The room/area sealing requirements will be specified which includes doors, penetrations, and the HVAC system. The preparation of the area will include the ability of equipment and supplies to be decontaminated during the process. Fan locations, humidity requirements, generation points, decontaminant circulation and distribution, and air flows will be discussed. Aeration methods, time requirements, monitoring, and offgassing will be described as well as methods of determining when safe re-entry can occur. Pictures will be utilized to demonstrate activities and techniques to enhance the learning experience.
Mark Czarneski - Director of Technology, Clordisys Solutions, Inc
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