CVEP73TS3

Millipore Express^® SHR 0.1µm Cartridge 30

Code 7 Silicone, Autoclavable and SIP

• Synonym(s): Millipore Express SHR Cartridge Filter 30 in. 0.1 μm Code 7 Silicone
• UNSPSC Code: 23151806
• eCl@ss: 32031690

Properties

• Product Name: Millipore Express^® SHR, Cartridge, pore size 0.1 μm, cartridge nominal length 30 in. (75 cm), Code 7, silicone seal
• material: polyethersulfone membrane; polypropylene housing; polypropylene support; silicone O-ring; silicone seal
• Quality Level: 400
• reg. compliance: meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
• sterility: non-sterile
• sterilization compatibility: autoclavable compatible; steam-in-place compatible
• product line: Millipore Express^®
• feature: hydrophilic
• manufacturer/tradename: Millipore Express^®
• parameter: 0.34 bar max. differential pressure (5 psi) at 135 °C (Forward); 1.0 bar max. differential pressure (15 psi) at 135 °C (Forward); 1.7 bar max. differential pressure (25 psi) at 80 °C (Forward); 2.1 bar max. differential pressure (30 psi) at 25 °C (Reverse); 6.9 bar max. differential pressure (100 psi) at 25 °C (Forward); 69 mbar max. differential pressure (1 psi) at 135 °C (Reverse)
• technique(s): sterile filtration: suitable
• L: 76.2 cm (30 in.)
• W: 2.7 in.
• cartridge nominal length: 30 in. (75 cm)
• diam.: 20.7 cm (8.1 in.)
• filtration area: 1.80 m² (19.5 ft²)
• impurities: <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• matrix: Millipore Express^® SHR
• pore size: 0.1 μm pore size
• input: sample type liquid
• bubble point: ≥2586 mbar (37.5 psig), nitrogen with 70/30% IPA/water at 23 °C
• cartridge code: Code 7

Description

General description

Device Configuration: Cartridge

Packaging

Double Easy-Open bag

Preparation Note

Sterilization Method
25 forward or 22 forward and 3 reverse SIP cycles of 30 min @ 135 °C; 25 autoclave cycles of 60 min @ 126 °C

This product was manufactured with a Millipore Express^® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).

Analysis Note

Bacterial Retention
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM^® F838 methodology.

TOC/Conductivity
After sterilization and a controlled water flush of 30 L, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64> at 25 °C.

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥3 L

Other Notes

Directions for Use

• Organism Retention: Microorganism
• Mode of Action: Filtration (size exclusion)
• Application: BioProcessing
• Intended Use: Reduction or removal of microorganism/bioburden
• Instructions for Use: Please refer wetting instructions of Filters with MILLIPORE EXPRESS^® Membrane user guide
• Storage Statement: Please refer Filters with MILLIPORE EXPRESS^® Membrane user guide
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.

Legal Information

ASTM is a registered trademark of American Society for Testing and Materials

MILLIPORE EXPRESS is a registered trademark of Merck KGaA, Darmstadt, Germany