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材料
polyester support
polyethersulfone
polypropylene (gamma-stable)
polypropylene housing
polypropylene vent cap
polysulfone
silicone seal
品質等級
法律遵循
meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
無菌
non-sterile
滅菌相容性
gamma compatible
產品線
Opticap® XL 10
特點
gamma compatible
hydrophilic
製造商/商標名
Millipore Express®
參數
≤32.7 mL/min air diffusion at 2.8 bar (40 psig) and 23 °C (in water)
1.0 bar max. differential pressure (15 psid) at 80 °C (Forward)
1.0 bar max. inlet pressure (15 psi) at 80 °C
100 psi max. differential pressure (6.9 bar) (intermittent)
2.1 bar max. differential pressure (30 psid) at 25 °C (Reverse; intermittent)
2.75 bar max. inlet pressure (40 psi) at 60 °C
25 °C max. inlet temp.
5.5 bar max. differential pressure (80 psid) at 25 °C (Forward)
5.5 bar max. inlet pressure (80 psi) at 25 °C
6.9 bar max. differential pressure (100 psid) at 25 °C (Forward; intermittent)
6.9 bar max. inlet pressure (100 psi) at 25 °C (intermittent)
80 psi max. differential pressure (5.5 bar) (continuous)
80 psig max. inlet pressure
技術
sterile filtration: suitable
長度
33.5 cm (13.2 in.)
寬度
4.2 in.
柱標稱長度
10 in. (25 cm)
直徑
10.7 cm (4.2 in.)
過濾面積
0.57 m2
入口接頭直徑
9/16 in.
入口到出口寬度
33.5 cm (13.2 in.)
出口接頭直徑
9/16 in.
雜質
≤0.25 EU/mL bacterial endotoxins (LAL test, Aqueous extraction)
<0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
基質
Millipore Express® SHF
孔徑
0.2 μm
起泡點
≥4000 mbar (58 psig), air with water at 23 °C
接頭
1/4 in. drain/vent hose barb (with double O-ring seal)
inlet hose barb
outlet hose barb
(14 mm (9/16 in.) Hose Barb Inlet and Outlet)
一般說明
包裝
其他說明
- Organism Retention: Microorganism
- Mode of Action: Filtration (size exclusion)
- Application: BioProcessing
- Intended Use: Reduction or removal of microorganism/bioburden
- Instructions for Use: Please refer installation section of OPTICAP® XL Capsules and OPTICAP® XLT Capsules user guide
- Storage Statement: Store in dry location
- Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.
準備報告
Gamma compatible to 45 kGy; 3 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable
分析報告
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
After sterilization and a controlled water flush of 11 L, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64> at 25 °C.
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