Single-Use Systems and Technologies

Why Should You Attend:

Single-use disposable bioprocessing products have gained rapid acceptance by biopharmaceutical manufacturer worldwide. Single-use disposable products have reduced contamination rates, enhanced production throughput and decreased overall operating costs. Recent collaborations between leading filtration, container /closure, mixing and cell culture companies have resulted in fully integrated single-use disposable bioprocessing platforms and systems.

This webinar will review the latest developments in single-use polymeric products, devices and their application in replacement of hardware. Practical illustrations will review the ‘how-to’ aspect of applying disposable technologies for their projects and process operations.

The program will explore how to increase productivity, reduce or eliminate cleaning and sanitization processes to reduce batch/cross batch contamination. It will also compare the significant material cost savings and reduction in operational expenses using disposables vs. hardware.

Learning Objectives:

• Identify applications where the use of disposables would be of practical advantage over hardware, e.g., cleaning validation.
• Understand the concepts of single-use technology to assist in writing change control documentation.
• Distinguish changes under the new regulatory process improvement guidelines, minor, moderate and significant.
• Designate which processes and production areas would most benefit from a change to disposable products.
• Describe the multiple cost saving analysis and plans for implementing and justifying the use of single-use disposable technology.

Areas Covered in the Webinar:

• Practical application of single-use technology in bioprocess and pharmaceutical process development and manufacturing.
• Change control and relative risk analysis and assessment to implement a single-use program.
• Regulatory requirements and documentation understanding needed in single-use applications.
• Benefits and cost savings realization from single-use programs.

Who Will Benefit:

• Process Development Engineers and Scientists
• Pilot-Plant Operations
• Production Management and Operation Staff
• Validation & QA/QC
• RA Personnel

Instructor Profile:

Mark Trotter, with over twenty years’ experience in the pharmaceutical and life science industries, has a broad range of work experience, from pharmacologic chemistry research project leader to marketing management in the laboratory and process equipment industries. This extensive background in the biopharmaceutical sciences is coupled with an in-depth regulatory knowledge that supports his expertise in these areas of process validation and qualification.

He has specialized training and work experiences in filter membrane technologies, including sterilizing, prefiltration, chromatography as well as single-use disposables technologies. Upstream fermentation to downstream applications, including separations, clarification and purifications processes technologies, are areas of subject matter expertise he brings to the training, technology transfer and consulting services. He completed his post-graduate studies at Long Island University, C.W. Post College, earning his MS in Medical Microbiology and continuing on for his MBA in Finance.

Mr. Trotter has published numerous technical articles, book chapters and has contributed expert editorial comment on these subjects. He is a member of PDA (Parenteral Drug Association), ASM (American Society of Microbiology) International Society for Pharmaceutical Engineering, (ISPE.), and the American Society of Quality, (ASQ), serving on ASTM E55 Biopharma Group and the USP Filtration Expert Panel.

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