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Millipore Express® SHF Cartridge Filters

High flow sterilizing-grade PES filters for validated process steps Más

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Cartuchos con juntas de silicona · Código 0, Juntas 2-222Borrar Clasificación y Filtrado Show Filter Hide Filter
Número de referencia	Tamaño de poro	Longitud nominal del cartucho
CGEP01TP3	0.2 µm	10 in. (25 cm)

Envases de 3 cartuchos.

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Cartuchos con juntas de silicona · Código 7, Juntas (2-226) con orejetas y flechaBorrar Clasificación y Filtrado Show Filter Hide Filter
Número de referencia	Tamaño de poro	Longitud nominal del cartucho
CGEP75TP3	0.2 µm	5 in. (12.5 cm)
CGEP71TP3	0.2 µm	10 in. (25 cm)
CGEP72TP3	0.2 µm	20 in. (50 cm)
CGEP73TP3	0.2 µm	30 in. (75 cm)

Envases de 3 cartuchos.
Los cartuchos de 10" (25 cm) de código 7 se suministran en envase individual para estudios de validación (sustituir el último dígito por 1).

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Cartuchos con juntas de EPDM · Código 7, Juntas (2-226) con orejetas y flechaBorrar Clasificación y Filtrado Show Filter Hide Filter
Número de referencia	Tamaño de poro	Longitud nominal del cartucho
CGEP75TE3	0.2 µm	5 in. (12.5 cm)
CGEP71TE3	0.2 µm	10 in. (25 cm)
CGEP72TE3	0.2 µm	20 in. (50 cm)
CGEP73TE3	0.2 µm	30 in. (75 cm)

Envases de 3 cartuchos.
Los cartuchos de 10" (25 cm) de código 7 se suministran en envase individual para estudios de validación (sustituir el último dígito por 1).

Volver al principio

Cartuchos con juntas de fluorocarbono · Código 7, Juntas (2-226) con orejetas y flechaBorrar Clasificación y Filtrado Show Filter Hide Filter
Número de referencia	Tamaño de poro	Longitud nominal del cartucho
CGEP75TF3	0.2 µm	5 in. (12.5 cm)
CGEP71TF3	0.2 µm	10 in. (25 cm)
CGEP72TF3	0.2 µm	20 in. (50 cm)
CGEP73TF3	0.2 µm	30 in. (75 cm)

Envases de 3 cartuchos.
Los cartuchos de 10" (25 cm) de código 7 se suministran en envase individual para estudios de validación (sustituir el último dígito por 1).

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Documentation

Material Qualification Dossier

Cargo	Versión
EMPROVE® Material Qualification Dossier for Millipore Express® SHF Cartridge Filters	1.0

Quality Management Dossier (Open Access)

Title
EMPROVE® Quality Management Dossier for Millipore Express® SHF Cartridge Filters

Operational Excellence Dossier

Title
EMPROVE® Operational Excellence Dossier for Millipore Express® SHF Cartridge Filters

Referencias bibliográficas

Visión general referencias
"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 2004
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 2004
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

Preguntas frecuentes

Pregunta	Respuesta
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.
How is Durapore membrane different than Millipore Express SHF?	Durapore membrane is made from a different polymer (polyvinylidene fluoride (PVDF) versus the polyethersulfone membrane of Millipore Express SHF) and has a different pore structure. These give Millipore SHF a flow advantage.
How is the Millipore Express SHF membrane different than the Millipore Express and Express Plus membranes used for Life Science filtration?	Millipore Express SHF was designed specifically for pharmaceutical applications, as a sterilizing grade, high flux, and caustic compatible membrane for large scale devices. Millipore Express and Express Plus membranes were designed for sterile filtration of tissue culture media and are not compatible with caustics. Millipore Express and Espress Plus are available only in laboratory scale devices.
Is the Millipore Express SHF filter difficult to wet?	No, the membrane is very hydrophilic.
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 wetting procedure for Millipore Express SHF OptiScales?	The wetting procedure for OptiScale with Millipore Express SHF is the same procedure for wetting OptiScale with Durapore: OptiScales are generally flushed with water, usually about 100 mls for a 47 mm disk.
Are integrity tests are run on Millipore Express SHF cartridges prior to release?	All Millipore Express SHF filters are 100% integrity tested prior to release.
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.

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Biopharmaceutical Manufacturing > Downstream Processing > Sterile Filtration > Sterile Liquid > Millipore Express^® > Millipore Express^® SHF

C8873High flow sterilizing-grade PES filters for validated process steps

Description

Millipore Express^® SHF (Sterile High-Flux) filters are an unparalleled combination of quality and process performance. A sterilizing-grade, hydrophilic polyethersulfone (PES) membrane, these filters provide sterility assurance, broad chemical compatibility, and exceptionally high flow rates for your validated process steps. Developed and designed for your validated sterile filtration processes, manufactured in a highly controlled process and supported by extensive documentation to fulfill your regulatory requirements.

Benefits

Highly efficient sterilizing-grade membrane
Designed for validated filtration steps which require sterility assurance

Drug Master File available
Retention testing on each lot of membrane and filter device
Each filter subject to the highest sensitivity integrity test in the industry
Validation kits available

Sterilization Capability

Autoclavable
Sterile
Gamma Compatible

Filter Formats

OptiScale^® small-scale disposable capsule filters
Opticap^® XL and XLT disposable capsule filters– autoclavable, sterile and gamma compatible
Cartridge filters

Regulatory Compliance

Filters are designed, developed and manufactured in accordance with a Quality Management System approved by an accredited registering body to the ISOR 9001 Quality Systems Standard.
Each filter and membrane lot is subjected to bacterial retention testing.
Every filter is subjected to the highest sensitivity integrity test in the industry.
All filters are shipped with a Certificate of Quality.
A Validation Guide, which is a summary of the product qualification, is available upon request.
For traceability and easy identification, each filter is identified with product name, lot number, and serial number.
Drug Master File is 16877DMF.

Multiple Formats Available

Millipore Express^® SHF filters feature faster flow rates, allowing you to process equivalent volumes with reduced filtration area. This high-flux benefit has been shown to deliver greater than 50% savings in filtration costs.

The Emprove^® Program

The Emprove^® Program complements the product portfolio through

Comprehensive documentation to support qualification, risk assessment and process optimization needs.
Consolidation of product specific testing, quality and regulatory information to simplify compliance requirements.
Convenient 24/7 access to up-to-date product information.

Cartridge Filters
	Cartridge Filters 5-inch	Per 10-inch Cartridge Filter
Nominal Dimensions
Diameter:	6.9 cm (2.7 in.)
Length:	12.5 cm (5 in.)	25.4 cm (10 in.)
Filtration Area	0.29 m² (3.1 ft²)	0.54 m² (5.8 ft²)
Materials of Construction
Filter membrane:	Hydrophilic polyethersulfone
Film edge:	Polypropylene
Core:	Polysulfone
O-rings:	Silicone, EPDM or fluoroelastomer
Maximum Differential Pressure
Forward:	6900 mbar (100 psi) at 25 °C 1700 mbar (25 psi) at 80 °C 340 mbar (5 psi) at 135 °C
Reverse:	2100 mbar (30 psi) at 25 °C 69 mbar (1 psi) at 135 °C
Bubble Point at 23 °C	≥ 4000 mbar (58 psi) air with water
Air Diffusion at 23 °C	Through a water wet membrane at 2750 mbar (40 psi):
	≤16.4 cc/min.	≤30 cc/min.
Bacterial Retention	Quantitative retention of 10⁷ CFU/cm² Brevundimonas diminuta ATCC^® 19146 per ASTM^® methodology
Bacterial Endotoxin	Aqueous extraction contains
TOC/Conductivity	Autoclaved cartridges meet the WFI requirements of USP <643> for Total Organic Carbon and USP <645> for Water Conductivity after a WFI water flush of:
	5.5 L at 25 °C	10 L at 25 °C
Oxidizable Substances	Effluent meets the USP Oxidizable Substance Test requirements for sterile purified water after a WFI flush of ≤100 mL.
Sterilization	Autoclave: May be autoclaved 25x, 60 min. cycles at 126 °C In-line Steam: 25x (forward) or, 22x (forward) and 3x (reverse), 30 min. cycles at 135 °C
USP Toxicity	Non-toxic per MEM elution ISO^® 10993-5.
Particle Shedding	Effluent meets the acceptance criteria set forth in USP <788> for large volume parenterals.
Non-fiber Releasing	Millipore Express^® SHF membrane meet the criteria for a “non-fiber releasing” filter as defined in 21 CFR 210.3 (b)(6).
Component Material Toxicity	Component materials were tested and meet the criteria of the USP <88> Reactivity Test for Class VI plastics. Millipore Express SHF filters meet the requirements of the USP <88> Safety Test, utilizing a 0.9% sodium chloride extraction.
Indirect Food Additive	All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177 – 182.
Good Manufacturing Practice	These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.

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Millipore Express® SHF Cartridge Filters

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