KGW1A05HH1
Polysep™ II 1.0/0.2/0.1 µm nominal, Opticap® XL Capsule
Synonym(s):
Opticap XL5 Polysep II 1.0/0.2/0.1 μm 9/16 in. HB/HB
Quality Level
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General description
Device Configuration: Capsule
Features and Benefits
Format: Triple Layer
Packaging
Double Easy-Open bag
Preparation Note
Sterilization Method
3 autoclave cycles of 30 min @ 121 °C; not in-line steam sterilizable
3 autoclave cycles of 30 min @ 121 °C; not in-line steam sterilizable
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).
Analysis Note
Gravimetric Extractables: after a 5 L flush and 24 hours in water at controlled room temperature
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥2 L
Other Notes
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 to the first page of Visual Inspection Guide and introduction section of the Mixed cellulose esters Tech Brief
- Storage Statement: Please refer to the Mixed cellulose esters Tech Brief
- Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.
Replaces: SN1M016A01
These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
Legal Information
OPTICAP is a registered trademark of Merck KGaA, Darmstadt, Germany
Polysep is a trademark of Sigma-Aldrich Co. LLC
Disclaimer
EMD Millipore Corporation certifies that this product complies with the European Pressure Equipment Directive, 97/23/EC of 29 May 1997. This product has been classified under Article 3 § 3 of the Pressure Vessel Directive. It has been designed and manufactured in accordance with sound engineering practice to ensure safe use. In compliance with Article 3 § 3 of this Pressure Vessel Directive, this product does not bear the CE mark.
Storage Class Code
11 - Combustible Solids
WGK
WGK 2
Regulatory Information
新产品
Certificates of Analysis (COA)
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