Quality Management Dossier
Operational Excellence Dossier
|Supply Robustness and Control|
|Millipore Express® SHF Hydrophilic Filters|
|Quality by Design (QbD) Principles in Aseptic Processing|
|"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 procedure for running a pre-use integrity test?||Millipore recommends sterilizing the filter prior to conducting a pre-use integrity test. (Ref. Steam-in-Place Method for Millipore Express SHF Filters Technical Brief, Lit#TB2000EN00) See also Millipore Express SHF integrity test recommendations.|
|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.|
|What Millipore Express SHF configurations are currently available?||Hydrophilic Millipore Express SHF 0.2 µm filters are currently available in 10-inch, 20-inch and 30-inch Code 0 & Code 7 cartridges, and in OptiScale capsules and 47 mm discs.
|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.
|How should I search for Millipore Express SHF on the Millipore web site?||We recommend typing “Millipore Express SHF” or “Express SHF”, including the quotes, into the search field. This will search for the entire phrase, and will display more targeted results than simply searching for the word “Express”.|
|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.|
|Why do Millipore Express SHF filters have such high flux?||Versus Durapore, the morphology of the Millipore Express SHF membrane is different - having been optimized to provide very high flow rates with clean intermediate streams, such as buffers, with complete assurance of sterility.|
|Filters with Millipore Express® Membrane -Wetting Instructions, Integrity Testing and Drying Guidelines|
|Wetting Instructions for Filter Units with Durapore Membrane|