物質
polyester support
polypropylene device
silicone seal
品質水準
無菌性
non-sterile
滅菌適合性
autoclavable compatible
steam-in-place compatible
製品種目
Milligard®
特徴
hydrophilic
メーカー/製品名
Milligard®
パラメーター
3.5 bar max. differential pressure (50 psid) at 25 °C
3.5 bar max. inlet pressure (50 psi) at 25 °C
テクニック
prefiltration: suitable
L
20 in.
W
2.9 in.
カートリッジの長さ(公称)
20 in. (50 cm)
フィルタ直径
2.8 in. (7.1 cm)
filter filtration area
1.6 m2
フィルタサイズ
20 in.
不純物
≤0.5 EU/mL bacterial endotoxins (LAL test, aqueous extraction)
<0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
マトリックス
Milligard® LPB
ポアサイズ
0.5 μm nominal pore size
0.5 μm pore size
カートリッジコード
Code 7
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詳細
Cartridge Type: Liquid
Device Configuration: Cartridge
Filter Grade: Low Protein Binding MILLIGARD® Media
特徴および利点
Format: Single Layer
包装
Double Easy-Open bag
調製ノート
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).
アナリシスノート
Gravimetric Extractables: The extractables level was ≤100 mg per 10-inch cartridge after a 5 L flush and 24 hours in water at controlled room temperature.
その他情報
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.
法的情報
MILLIGARD is a registered trademark of Merck KGaA, Darmstadt, Germany
OptiScale is a registered trademark of Merck KGaA, Darmstadt, Germany
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