0.35 bar max. differential pressure (5 psid) at 123 °C (Forward) 0.35 bar max. inlet pressure (5 psi) at 123 °C (Forward) 0.7 bar max. differential pressure (10 psid) at 25 °C (Reverse) 0.7 bar max. inlet pressure (10 psi) at 25 °C (Reverse) 1.7 bar max. differential pressure (25 psid) at 80 °C (Forward) 1.7 bar max. inlet pressure (25 psi) at 80 °C (Forward) 4.1 bar max. differential pressure (60 psid) at 25 °C (Forward) 4.1 bar max. inlet pressure (60 psi) at 25 °C (Forward) 75 L/min flow rate at 2.1 bar (ΔP)
Sterilization Method 5 SIP cycles of 60 min @ 135 °C; 5 autoclave cycles of 60 min @ 126 °C
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
使用 ≥200 mL 水冲洗后,将符合“USP 氧化物检测”要求
Gravimetric Extractables: using sterilized device after 24 hours in water at controlled room temperature
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 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.
These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
法律資訊
Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany
MILLIDISK is a registered trademark of Merck KGaA, Darmstadt, Germany