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材料
polyethersulfone membrane
polypropylene
polypropylene support
polypropylene vent cap
品質等級
無菌
non-sterile
滅菌相容性
autoclavable compatible
產品線
OptiScale® 25
特點
hydrophilic
製造商/商標名
OptiScale®
參數
0 bar max. differential pressure (Reverse)
4.14 bar max. differential pressure (60 psi) at 25 °C (Forward)
60 psi max. inlet pressure (4.1 bar)
技術
prefiltration: suitable
長度
3.9 cm (1.52 in.)
寬度
1.21 in.
直徑
3.1 cm (1.2 in.)
過濾面積
3.5 cm2
雜質
<0.25 EU/mL bacterial endotoxins (LAL test, per device; aqueous extraction; meeting requirements of USP <85>, EP 2.6.14 and JP 4.01)
基質
Milligard® PES
pore size
1.2/0.8 μm pore size
接頭
female Luer-Lok® inlet connection
male Luer-Lok® outlet connection
(Female Luer-Lok® Inlet/Male Luer Slip Outlet)
柱代碼
not applicable
相关类别
一般說明
Device Configuration: 取样皿滤膜
其他說明
These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
Directions for Use
- Organism Retention: Bacterial
- Mode of Action: Filtration (size exclusion)
- Application: Protein purification
- Intended Use: Reduction or removal of microorganism/bioburden
- Instructions for Use: Please refer installation and wetting sections of OPTISCALE®-25 user guide
- Storage Statement: Please refer OPTISCALE®-25 user guide
- Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.
準備報告
Devices tested and meet requirements of USP <78> for large volume parenterals.
Sterilization Method
Capsule integrity was maintained after 1 autoclave cycle of 60 minutes at 123 °C.
Capsule integrity was maintained after 1 autoclave cycle of 60 minutes at 123 °C.
分析報告
This product was tested and passes the USP test for particulates in injectables.
法律資訊
Luer-Lok is a registered trademark of Becton-Dickinson & Co.
MILLIGARD is a registered trademark of Merck KGaA, Darmstadt, Germany
OptiScale is a registered trademark of Merck KGaA, Darmstadt, Germany
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