Quality Segment
material
borosilicate glass fiber (BGF) , polypropylene , polypropylene support, silicone seal
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
4 in.
W
2.7 in.
cartridge nominal length
4 in. (10 cm)
diam.
7.4 cm (2.9 in.)
filtration area
0.19 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
≤88 mg/cartridge
matrix
Lifegard™
pore size
2.0 μm nominal pore size, 2.0 μm pore size
input
sample type liquid
cartridge code
Code M (2-118; O-rings)
General description
Device Configuration: カートリッジ
Features and Benefits
Filter Grade: AP20
Format: Single Layer
Packaging
ダブル イージーオープン バッグ
Preparation Note
Sanitization Protocol
80 °Cで30 分 熱水殺菌
80 °Cで30 分 熱水殺菌
Sterilization Method
121 °C 30 分のオートクレーブ滅菌またはSIP滅菌10回
121 °C 30 分のオートクレーブ滅菌またはSIP滅菌10回
Analysis Note
次の水でフラッシング後USP Oxidizable Substances Testに適合 ≥5 L
Gravimetric Extractables: after 24 hours in water at controlled room temperature
Other Notes
これらの製品はFDAの定めたGMP準拠の製造工場で製造されています。
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.
Legal Information
Lifegard is a trademark of Merck KGaA, Darmstadt, Germany
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試験成績書(COA)
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