MPGL10CB

Gamma Compatible Millipak^® -100

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

• 别名: Gamma Compatible Millipak^®-100 Filter Unit 0.22 µm 1/4 in. NPTM
• 分類程式碼代碼: 23151806

属性

• 材料: PVDF
• 品質等級: 400
• 無菌: sterile
• 產品線: EMPROVE^® Filter
• 特點: hydrophilic
• 製造商／商標名: Millipak^®
• 過濾面積: 500 cm²
• 入口接頭直徑: 1/4 in.
• 出口接頭直徑: 1/4 in.
• 雜質: <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• 重量法萃取物: ≤2.5 mg/device
• 基質: Durapore^®
• 孔徑: 0.22 μm pore size
• 接頭: NPT inlet connection; NPT outlet connection

说明

一般說明

Device Configuration: 取样皿滤膜

Number of stacked discs: 100 discs

其他說明

These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.

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.

準備報告

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).

分析報告

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

法律資訊

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