MPGL10CB

ガンマ照射対応Millipak^® -100

pore size 0.22 μm, filtration area 500 cm², matrix Durapore^®

• 別名: Gamma Compatible Millipak^®-100 Filter Unit 0.22 µm 1/4 in. NPTM
• UNSPSCコード: 23151806

特性

• 物質: PVDF
• 品質水準: 400
• 無菌性: sterile
• 製品種目: EMPROVE^® Filter
• 特徴: hydrophilic
• メーカー／製品名: Millipak^®
• ろ過面積: 500 cm²
• 入口接続部直径: 1/4 in.
• 出口接続部直径: 1/4 in.
• 不純物: <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• 重量分析抽出物: ≤2.5 mg/device
• Matrix: Durapore^®
• ポアサイズ: 0.22 μm pore size
• フィッティング: NPT inlet connection; NPT outlet connection

詳細

詳細

Device Configuration: カプセル

Number of stacked discs: 100 discs

その他情報

これらの製品はFDAの定めたGMP準拠の製造工場で製造されています。

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 Wetting Instructions for Filter Units with Durapore^® Membrane user guide
• Storage Statement: Store in dry location
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

調製ノート

Sterilization Method
3 autoclave cycles of 90 min @ 123°C; not in-line steam sterilizable

This product was manufactured with a Durapore^® membrane 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

Bacterial Retention
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM^® F838 methodology.

Gravimetric Extractables: after 24 hours in water at controlled room temperature

法的情報

ASTM is a registered trademark of American Society for Testing and Materials

Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany

Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany

MILLIPAK is a registered trademark of Merck KGaA, Darmstadt, Germany