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Large Volume Sterile Fluid Transfer Made Simple with the Kleenpak™ II Sterile Connector

As single-use technologies become more widely used in upstream, downstream and formulation and filling processes, biopharmaceutical manufacturers are continually looking for innovative and practical solutions to make secure, permanent sterile connections of large single-use systems (≥100 L) in uncontrolled environments.

Recognizing the clear need for a connector device for biomanufacturing commercial applications that involve the sterile transfer of large fluid volumes, Pall Life Sciences designed and developed the Kleenpak II sterile connector. This webinar will cover the design and operation of the Kleenpak II sterile connector and focus on the validation of this technology. Application data will also be presented from our applications R&D group along with some practical examples of how the Kleenpak II sterile connector can be successfully integrated into a variety of single-use systems across both upstream and downstream applications.

Participants will learn:

  • The design philosophy behind Kleenpak II sterile connector and its compliance with the various compendial standards.
  • How the Kleenpak II sterile connector has been rigorously tested in various different biopharmaceutical applications and processes.
  • How you can use Kleenpak II sterile connectors along with other Pall technologies to truly realize a completely disposable manufacturing facility for commercial scale operation.

Presenters and Participants in the Panel Discussion and Q & A

Moderator

Ian Sellick 
 
Marketing Director
Pall Life Sciences
(Port Washington, NY, USA)

Ian Sellick is the Marketing Director for Pall Life Sciences, a division of Pall Corporation, a $2.8 billion supplier of filtration, separation and fluid management products. At Pall, Ian is responsible for tactical and strategic marketing, with special emphasis on the state-of-the-art in single-use technology implementation. Within Pall, Ian was previously responsible for management of tangential flow filtration technologies, was on development teams for membrane chromatography, and virus removal technologies. Prior to joining Pall, Ian has held positions at other separations companies involved in cell harvesting and removal, and general research, development and production purification technologies. Ian has been the manager of the blood analysis laboratory at CSL, and subsequently senior chemist. Ian holds an Honors Bachelor's Degree in Zoology from Bristol University (England), is a member of ISPE, ASME and the American Chemical Society. Ian has published a large number of articles and papers in the biological and biopharmaceutical sciences, presented globally on vaccine manufacturing, published papers on separations for food and dairy derived products, as well as the Institute of Brewing's book on beer filtration. He speaks regularly at conferences on separations and technologies for the biotechnology industry.

Presenter and Panelist

James Barry

Global Product Manager
Allegro™ Single-Use Technologies
Pall Life Sciences
(Portsmouth, UK)

James Barry is the Global Product Manager for Formulation and Filling for the Allegro single-use technologies for Pall Life Sciences. James is a qualified Chemical Engineer and is currently studying for his masters in Biopharmaceutical Sciences. Prior to joining Pall Life Sciences, James spent over eight years working for GlaxoSmithKilne in a variety of roles across different divisions and manufacturing sites. His experience includes primary, secondary and sterile manufacture with expertise in technical transfer, new product introduction and new technology introduction. He is a member of both the PDA and ISPE and has spoken at various single-use technology events.

Presenter and Panelist  

Anil Kumar, Ph.D.

Senior R &D Manager
Allegro Single-Use Technologies
Pall Life Sciences
(Westborough, MA, USA)

Dr. Anil Kumar is the Senior R&D Manager for the Allegro single-use technologies at Pall Life Sciences. At Pall, Anil’s focus has been on design and execution of studies to evaluate suitability of new product to the targeted applications, evaluation of new and emerging technologies, and in helping biopharmaceutical customers with their process development via Pall's newly created Process Development Service. While at Pall, Anil has provided applications support for successful launch of 12 new products, which includes Allegro Single- Use Mixers, Kleenpak™ Sterile Disconnector, Stax™ Single- Use Depth Filtration platform, and 0.1 µm-rated EDT, a mycoplasma retentive filter and 0.2 µm-rated ECV, a high-flow and high capacity sterilizing grade filter products.

Anil is a qualified Chemical Engineer with technical expertise in design of fluidic system. Prior to joining Pall Life Sciences; Anil spent seven years working on projects sponsored by NASA for clarifying fluid in space, Sandia National Laboratory for detecting trace amount of pathogens in an environment, and National Science Foundation for developing new methods for controlled manipulation of species in a micro-fluidic devices, as part of his doctorate and post doctorate research work. Anil has publishing his work in trade magazines, peer-reviewed journals, and also filed a US patent.

 Presenter and Panelist  

James Hathcock, Ph.D.

Sr. Director of Global Validation Chemistry
Pall Life Sciences
(Port Washington, NY, USA)

Dr. James Hathcock is the Senior Director of Global Validation Chemistry at Pall Life Sciences, responsible for the extractables and leachables characterization of biopharmaceutical products. Since joining Pall in 2008, James has been actively involved in chemical and performance characterization of medical and biopharmaceutical products, as well as relevant technical packages supporting FDA 510k filings. Prior to joining Pall, James was an assistant professor of hematology at the Mt. Sinai School of Medicine in New York City, where he served as director of a protein production and purification core laboratory. He is a member of the PDA and ASTM organizations.

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  • Yes
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  • Active pharmaceutical ingredients
  • Animal health
  • Bioprocess engineering
  • Biotechnology
  • Drug discovery
  • Formulation and filling
  • Molecular diagnostics
  • Pharmaceutical QC
  • Plasma fractionation
  • Vaccines
  • Other
  • Cell culture
  • Chromatography
  • Clarification and prefiltration
  • Concentration & diafiltration
  • Process monitoring
  • Protein Structure and Function
  • Purification
  • Separation/filtration
  • Sterile filtration and bioburden control
  • Venting and gas filtration
  • Viral clearance
  • Other
  • Upstream (cell culture/fermentation/harvesting)
  • Downstream (purification/formulation & filling)
  • Both
  • Neither
  • Bioreactors
  • Filter Capsules
  • Chromatography products
  • Connectors
  • Housings
  • Integrity test instrumentation
  • Sheet filters and sheet filter modules
  • Single-use systems
  • Systems (biopharmaceutical)
  • Tangential flow/crossflow products
  • Testing and monitoring products
  • Filling Needles
  • Connector validation
  • Consulting services
  • Contamination analysis
  • Filter validation
  • Pre-inspection reviews
  • Process development
  • Process proteomics
  • Single-use validation
  • Test equipment validation
  • Contract analytical services