Material Qualification Dossier
Quality Management Dossier
Operational Excellence Dossier
|Supply Robustness and Control|
|Quality by Design (QbD) Principles in Aseptic Processing (EMD)|
|"Schneller und effizienter" (Faster and more efficient)|
Ulrich Hoebel, Key Account Manager for Boehringer Ingelheim & Regional Sales Manager in Central Area
Biotechnica Today, official journal of the Hannover tradeshow Biotechnica, published by the German magazine Laborpraxis, issue October 18 2005, page 9 2005
|Filtración esterilizante rápida y económica: tecnologia de membrana Express® (Faster Sterile Filtration with New Membrane Technology)|
Josep Vilella, Bioprocess Marketing, Tech Service and internal Support Specialist in Spain
Tecnicas de Laboratorio (Spanish magazine), issue 306, November 2005 , page 975 2005
|Increasing the Speed of Buffer Filtration; Tutorial: Millipore Express SHF Filters Utilize Composite Asymmetric Polyethersulfone Sterile Membrane|
Laurelle Sciola-Tulecke and Susan Barrett
GEN, Volume 23, Number 14, August 2003 2003
|What is the recommended wetting procedure for Millipore Express SHF cartridges?||Per Millipore's standard wetting procedure:
Wet the dry cartridge at 1 lpm/ft2 for 5 minutes. This flow rate corresponds to 5.8 lpm (1.5 gpm) for a 5.8 ft2 cartridge.
It is also possible to wet the filter at a lower flow rate than recommended for a longer duration (i.e.; 3L/min for 10 minutes) and pass the integrity test.
|What is the recommended wetting procedure for Millipore Express SHF 47mm discs?||The wetting procedure for Millipore Express SHF discs is the same procedure for wetting Durapore 47mm discs: Dip the 47 mm disk in water or buffer prior to inserting in the holder. Make sure there are no air bubbles present between the membrane and the support material.|
|What is the recommended integrity test for Millipore Express SHF filters?||The recommended integrity test for Millipore Express SHF filters is either an air/water diffusion test or an enhanced bubble point test; consisting of a diffusion test followed by a bubble point test.
Note: If a product specific integrity testing is desired, contact ACCESS services for assistance.
|How do I integrity test this filter?||For diffusion testing, cartridge integrity can be measured either: 1) .visually with a downstream mass flow monitor, or 2). with an inverted graduated cylinder, or 3). using an automated integrity tester. For bubble point testing, an enhanced bubble point test (diffusion test followed by a bubble point test) using an automated integrity tester is recommended.|
|What is the recommended procedure if I get a failing integrity test value?||Rewet according to the SHF insert, using up to 45 psig backpressure, and retest the cartridge using either an air/water diffusion test or an enhanced bubble point test; consisting of a diffusion test followed by a bubble point test.|
|What is the recommended procedure for storing Millipore Express SHF filters (pre-use)?||Per the Millipore Express SHF Wetting and Integrity Testing, Package Insert (P88057): “Filter Storage Conditions: Store filters at room temperature in their original packaging and away from direct sunlight. Do not remove filter from its bag until ready to use.”|
|What is the recommended procedure for returning Millipore Express SHF filters (post use)?||Return filters to original packaging materials and contact Technical Services for further details.|
|Is the Millipore Express PES technology platform new to Millipore?||No. In 1992, Millipore was granted the first patent on the Express membrane. Millipore’s Life Science division introduced the first generation of the Express PES membrane in 1995. Since then, successive generations of the Express membrane using advanced technologies have been introduced; with the Express Plus (2002) and now the Express SHF (2003).
Millipore Express SHF membrane is the next generation of the Millipore Express technology - enabling caustic compatible, high flow rate, process scale devices.
|What literature is available for the Millipore Express SHF?||
* Contact Technical Service for Validation Guides.
|Is Millipore Express SHF a sterilizing grade membrane?||Yes. The Millipore Express SHF membrane meets ASTM requirements of quantitative retention of 107 CFU/cm2 Brevundimonas diminuta ATCC® 19146 per ASTM methodology. Millipore Express SHF has the same probability of producing a sterile effluent as Durapore. The retention standards (ASTM 838-83) and protocols (ASTM, HIMA methodology) that were used to validate Durapore membrane were used to validate Millipore Express SHF.|
|Filters with Millipore Express® Membrane -Wetting Instructions, Integrity Testing and Drying Guidelines|
|Wetting Instructions for Filter Units with Durapore Membrane|