material
polypropylene device, polypropylene support, silicone seal
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
cartridge nominal length
4 in. (10 cm)
device size
4 in.
filter diam.
2.9 in. (7.4 cm)
filter filtration area
0.16 m2
impurities
≤1.0 EU/mL bacterial endotoxins (LAL test, aqueous extraction), <1.0 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
gravimetric extractables
≤100 mg/cartridge
matrix
Lifegard™
pore size
1.0 μm nominal pore size, 1.0 μm pore size
code
Code N
General description
Device configuration: Cartridge
Cartridge type: Liquid
Cartridge type: Liquid
Features and Benefits
Filter Grade: AP15
Format: Single Layer
Packaging
Double Easy-Open bag
Preparation Note
Sterilization Method: 10 autoclave cycles or SIP at 121°C for 30 min
Analysis Note
Gravimetric Extractables: The extractables level was ≤ 100 mg per 4-inch cartridge after 24 hours in water at controlled room temperature.
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 5 L
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 5 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 to 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
Legal Information
Lifegard is a trademark of Merck KGaA, Darmstadt, Germany
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