一般描述
Device Configuration: Cartridge
包装
Double Easy-Open bag
制备说明
Sterilization Method: Device integrity and retention was maintained after 3 autoclave cycles of 90 minutes at 126 °C. Devices can withstand a dose ≤40 kGy gamma exposure.
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), validated based on large volume parenteral specifications as detailed in USP 788 Particulate Matter in Injections
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), validated based on large volume parenteral specifications as detailed in USP 788 Particulate Matter in Injections
其他说明
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 general guidelines section of user guide shipped with this product
- Storage Statement: Please refer user guide shipped with this product
- Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations
These products are manufactured in a facility which is certified to ISO 9001:2015 Quality Management Systems.
法律信息
Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany
MILLIPAK is a registered trademark of Merck KGaA, Darmstadt, Germany
法规信息
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