Aseptic Filling

Venue: San Diego

Location: San Diego, California, United States

Event Date/Time: May 25, 2004 End Date/Time: May 26, 2004
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The Institute for International Research is proud to bring you the premier Aseptic Filling conference. This two-day event is designed to address the key issues currently facing pharmaceutical aseptic filling professionals including regulatory compliance, operational design, validation techniques, microbiological contaminants, training of personnel and selection of contract aseptic manufacturer. An understanding of these and other issues enables your team to master the intricacies of aseptic filling and successfully achieve cGMP compliance while maintaining overall product quality.

The mission of this premier conference designed specifically for pharmaceutical scientists, manufacturing, validation, quality assurance and control, and operational personnel is to address the keys to success that aid in avoiding unwanted 483's. This mission is achieved by gathering industry experts that face aseptic filling challenges in multiple areas form designing complete aseptic programs, to sterilizing the lyophilizer.

New technologies, such as barrier isolation and blow fill seal technology, are becoming more frequently used to aseptically fill liquid pharmaceuticals so that exposure to the external environment is further limited. With the development and implementation of new technologies, it has become necessary to gain FDA approval in order to use these custom designed systems. Is this a worthwhile endeavor for your manufacturing team?

Is your team prepared to react to changes in regulatory criteria? Are you up to date on the latest technologies and how they can impact and streamline your program? Does your team consistently meet sterility assurance requirements?

Understanding the FDA expectations for aseptic filling
Determining if implementing barrier isolation technology to your aseptic filling processes is best suited for your facility
Identifying the sterilization process for aseptic lyophilizer
Designing operational systems for the most effective containment strategies for microbiological contaminants
IIR’s premier Aseptic Filling conference presents an opportunity to gain exposure to companies and industry experts leading the pace toward providing the most appropriate, efficient, cost effective, and safety aseptic filling processes. If you are involved in aseptic filling at a pharmaceutical, biotech, or contract aseptic manufacturing company, you will benefit by attending this industry gathering.

Register Today. Space is Limited. Have your entire team benefit by taking advantage of our group discount - send four individuals from the same company and receive a 15% discount off each registration. Please use the registration form on the back of this brochure. Or, if you prefer, phone us at (888) 670-8200 US; (941) 951-7885 Int’l; or fax us at (941) 365-2507. We look forward to greeting you on May 25th in San Diego.

Learning Objectives for the Aseptic Filling Conference

Conference overview: current aseptic filling environment
Determine the FDA expectations in aseptic filling including a review of the draft fda guidance
Compare 1987 Guideline on Sterile drug Products produced by aseptic processing with 2003 draft guidelines
Understand strategies for barrier isolator validation and stopper processing
Integrate blow fill seal technology in your aseptic filling processes
Identify high speed aseptic fill-finish design & operation
Walk through the sterilization process for lyophilization of aseptic fill-finish
Establish HVAC and laminar air flow design and qualification
Hear best demonstrated aseptic techniques and practices
Determine selection strategies for an aseptic fill-finish contract organization