General description
Device Configuration: Capsule
Packaging
Double Easy-Open bag
Preparation Note
Sterilization Method:
Gamma Compatible to 45 kGy. May be autoclaved for 3 cycles of 60 min at 123 °C; not in-line steam sterilizable
This product was manufactured with a MILLIPORE EXPRESS® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
Analysis Note
Bacterial Retention: Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 107 CFU/cm2 using ASTM® F838 methodology.
TOC/Conductivity: After sterilization and a controlled water flush of 2.0 L, samples exhibited < 500 ppb TOC per USP < 643 < and < 1.3 μS/cm per USP < 645 < at 25 °C.
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 1 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 installation section of OPTICAP® XL Capsules and OPTICAP® XLT Capsules user guide
- Storage Statement: Store in dry location
- Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations
Legal Information
ASTM is a registered trademark of American Society for Testing and Materials
MILLIPORE EXPRESS is a registered trademark of Merck KGaA, Darmstadt, Germany
OPTICAP is a registered trademark of Merck KGaA, Darmstadt, Germany
- UPC:
- 41115700
- Condition:
- New
- Weight:
- 1.00 Ounces
- HazmatClass:
- No
- WeightUOM:
- LB
- MPN:
- KVEPG015FF1