PALLTRONIC FLOWSTAR LGR TEST INSTRUMENT

Transcription

1 PALLTRONIC FLOWSTAR LGR TEST INSTRUMENT Webinar Information Due to numerous benefits, including flexibility, absence of cross contamination, and elimination of cleaning validation, single-use technology is being widely adopted by the biopharmaceutical industry, even in very critical applications, such as formulation and filling. In these applications, the drug product is typically high value and/or highly potent. Typically, a strong Quality by Design approach and several leak tests are performed during single-use systems manufacturing. However, end users also need to mitigate any risk of product loss or operator exposure due to the potential risk of a single-use system leaking during drug product processing. As part of a risk assessment and mitigation strategy, one robust approach for the end user is to perform point-of-use (in situ) leak testing of single-use assemblies using the new Palltronic Flowstar LGR test instrument. In this webinar, we will present an overview on how to test singleuse systems with the Palltronic Flowstar LGR instrument and the expected benefits from the end user s perspective. Presenters and Participants in the Panel Discussion and Q & A Moderator and Presenter Mani Krishnan Vice President of Global Biopharm Technical Services and Scientific Affairs Pall Corporation (Westborough, MA, USA) Mani Krishnan is the Vice President of Global Biopharm Technical Services and Scientific Affairs at Pall Corporation. Mani has been in the life sciences industry for over 20 years and has held positions of increasing responsibility in process development, R&D and regulatory strategy. Mani has a Masters degree in Chemical Engineering. He holds two patents and has published journal articles and text book chapters on topics such as virus filtration, protein concentration/diafiltration, single-use processing and integrity testing. He is a member of various professional/industry organizations such as PDA, ISPE, ASME, ASTM, etc. and was the member of the Executive Board at BPSA until December Presenter and Panelist Anil Kumar, Ph.D. Senior R & D Manager

2 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 Nathalie Pathier Global Product Manager Allegro Single-use Technologies Pall Life Sciences (Saint-Germain-en-Laye, France) Nathalie Pathier is a Global Product Manager for Single-Use Technologies at Pall. She has more than 25 years of experience working on Bioprocesses. She joined Pall as a Marketing Manager in 2004 and has been dealing with product management in tangential flow filtration and single-use systems since She was previously a Project Manager in the biopharmaceutical industry and she designed and implemented engineered process solutions for downstream processing. She has an Engineering Degree in Food Industry and a Master Degree in Business Administration from the Sorbonne Graduate Business School in Paris. In her current position she is responsible for the development of relevant solutions

3 for single-use systems leak testing Q&A Bubble test for filter is possible but performed at a much higher pressure than the one for bag testing Same instrument as the previous version Compatibity with competitive bag requires clamping of tubing end and a sterile vent filter A statistical study is required to validate the test result with competitive bag Rational for establishing 50mbar test pressure: optimum for quick test time (high presure) and to prevent damage to bag (low pressure) Higher pressure for air leak testing tubing assembly than the one for bag testing Avoid temperature swing in the room during test Best if temp +/- 1degC during test (20min) Use a sterile vent filter to maintain sterility for PreUse IT Utilility: o Electrical o 6 bar compressed air Not compatible with bag volume >200L Determination of threshold values: internal statistical study with bag of different volume and different configuration (no data was shown or discussed) No correlation with microbiol challenge No favorable of restraining plate due to the risk of bag damage (?) and incompatibity with in situ test (?) Air is filled thru a vent filter for the test and is evacuated during liquid fill 3D bag Personnal comment Good marketing presentation on a leak test product with multiple interesting features (compatible with 2D, 3D bag, assembly without bag, filter, bar code, electronic record, electronic signature) but with only a sensivity limited to 30 m leak.

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