製品名
エアベント® 0.2 µm、Optiseal®カートリッジ, Chemistry: Hydrophobic Polytetrafluoroethylene (PTFE) Configuration: 4 in.
Quality Segment
material
PTFE , polypropylene , polypropylene support, silicone seal
sterility
non-sterile
sterilization compatibility
steam-in-place compatible
product line
OptiSeal® 4 in.
feature
hydrophobic
manufacturer/tradename
OptiSeal®
parameter
≤6 mL/min nitrogen diffusion at 965 mbar (14 psig) and 23 °C (in 70/30% IPA/water), 0.35 bar max. differential pressure (5 psid) at 135 °C (Forward), 0.35 bar max. inlet pressure (5 psi) at 135 °C (Forward), 1.7 bar max. differential pressure (25 psid) at 80 °C (Forward), 1.7 bar max. inlet pressure (25 psi) at 80 °C (Forward), 4.1 bar max. differential pressure (60 psid) (Reverse), 4.1 bar max. inlet pressure (60 psi) (Reverse;), 5.5 bar max. differential pressure (80 psid) at 25 °C (Forward), 5.5 bar max. inlet pressure (80 psi) at 25 °C (Forward)
technique(s)
gas filtration: suitable
L
4 in.
cartridge nominal length
4 in. (10 cm)
filtration area
0.18 m2
impurities
≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction), <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
gravimetric extractables
≤10 mg/cartridge
matrix
Aervent®
pore size
0.2 μm pore size
input
sample type liquid
bubble point
≥1100 mbar (16 psig), nitrogen with 70/30% IPA/water at 23 °C
cartridge code
not applicable
General description
Packaging
Preparation Note
135 °C 30 分のSIP 80回 (正方向 40回/逆方向 40回) ; 135 °C 30 分のオートクレーブ滅菌 80回
Analysis Note
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
Other Notes
- 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
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試験成績書(COA)
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