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材料
polyester support
polypropylene device
silicone seal
品質等級
法律遵循
meets EU 1935/2004/EC (alll component materials)
meets FDA 21 CFR 177-182 (all component materials)
無菌
non-sterile
滅菌相容性
autoclavable compatible
steam-in-place compatible
產品線
Milligard®
特點
hydrophilic
製造商/商標名
Milligard®
參數
3.5 bar max. differential pressure (50 psid) at 25 °C
3.5 bar max. inlet pressure (50 psi) at 25 °C
技術
prefiltration: suitable
長度
40 in.
寬度
2.9 in.
柱標稱長度
40 in. (100 cm)
過濾器直徑
2.8 in. (7.1 cm)
過濾器過濾面積
3.2 m2
過濾器尺寸
40 in.
雜質
≤0.5 EU/mL bacterial endotoxins (LAL test, aqueous extraction)
<0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
基質
Milligard®
孔徑
1.2 μm nominal pore size
1.2 μm pore size
柱代碼
Code 0
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一般說明
Cartridge Type: Liquid
Device Configuration: Cartridge
Filter Grade: Standard MILLIGARD® Media
特點和優勢
Format: Single Layer
包裝
Double Easy-Open bag
準備報告
Sterilization Method: 10 autoclave cycles or SIP at 121 °C for 30 min
This product was manufactured with a media combination which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
This product was manufactured with a media combination which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
分析報告
Gravimetric Extractables: The extractables level was ≤50 mg per 10-inch cartridge after 24 hours in water at controlled room temperature.
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥9 L
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥9 L
其他說明
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 installation and wetting sections of OPTISCALE® -25 user guide and introduction section of Mixed cellulose esters Tech Brief
- Storage Statement: Please refer Mixed cellulose esters Tech Brief
- Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations
These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
法律資訊
MILLIGARD is a registered trademark of Merck KGaA, Darmstadt, Germany
OptiScale is a registered trademark of Merck KGaA, Darmstadt, Germany
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