CP1571S03

Lifegard^™ 1.0 µm nominal, Cartridge

pore size 1.0 μm, cartridge nominal length 10 in. (25 cm)

• Synonym(s): Lifegard^™ Cartridge Filter 10 in. 1.0 μm Code 7
• UNSPSC Code: 23151806
• eCl@ss: 32031610

Properties

• material: borosilicate glass fiber (BGF) ; polypropylene ; polypropylene support; silicone seal
• Quality Level: 400
• sterility: non-sterile
• sterilization compatibility: autoclavable compatible; steam-in-place compatible
• product line: Lifegard^™
• feature: hydrophilic
• manufacturer/tradename: Lifegard^™
• parameter: 3.5 bar max. differential pressure (50 psid) at 25 °C; 3.5 bar max. inlet pressure (50 psi) at 25 °C
• technique(s): prefiltration: suitable
• L: 10 in.
• W: 2.7 in.
• cartridge nominal length: 10 in. (25 cm)
• diam.: 7.4 cm (2.9 in.)
• filtration area: 0.46 m²
• impurities: ≤1.0 EU/mL bacterial endotoxins (LAL test, Aqueous extraction); <0.1 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• gravimetric extractables: ≤250 mg/cartridge
• matrix: Lifegard^™
• pore size: 1.0 μm nominal pore size; 1.0 μm pore size
• input: sample type liquid
• cartridge code: Code 7

Description

General description

Device Configuration: Cartridge

Features and Benefits

Format: Single Layer

Packaging

Double Easy-Open bag

Other Notes

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

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 Steam Sterilization & Integrity Testing Procedures guide and first page of Visual Inspection Guide
• Storage Statement: Store in dry location
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

Specifications

Filter Grade: AP15

Preparation Note

Sanitization Protocol
30 min with hot water @ 80 °C

Sterilization Method
10 autoclave cycles or SIP @ 121 °C for 30 min

Analysis Note

Gravimetric Extractables: after 24 hours in water at controlled room temperature

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥5 L

Legal Information

Lifegard is a trademark of Merck KGaA, Darmstadt, Germany