material
polyester support
polyethersulfone membrane
polypropylene (end cap)
polypropylene housing
polysulfone (core)
Quality Level
sterility
non-sterile
Sterilization Compatibility
autoclavable compatible
gamma compatible
product line
Opticap® XL 10
feature
hydrophobic
parameter
15 psi max. pressure at 80 °C (forward)
30 psi max. pressure at 4—50 °C (reverse)
60 psi max. pressure at 4—50 °C (forward)
technique(s)
gas filtration: suitable
body diam.
10.7 cm (4.2 in.)
capsule L
33.3 cm (13.1 in.)
diam.
14.5 cm (5.7 in.) , vent to vent
filtration area
0.87 m2
inlet connection diam.
9/16 in.
outlet connection diam.
9/16 in.
impurities
<0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
gravimetric extractables
≤54 mg
matrix
Millipore Express® SPG
pore size
0.2 μm pore size
fitting
(14.3 mm (9/16 in.) Sanitary Flange Inlet and Outlet)
shipped in
ambient
General description
Packaging
Other Notes
- 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
Preparation Note
Gamma compatible to 40 kGy; 1 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable
This product was tested and meets requirements of USP <788> for large volume parenterals.
Analysis Note
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 107 CFU/cm² using ASTM® F838 methodology.
Gravimetric Extractables:The extractable level was equal to or less than 27 mg/device after 24 hours in a 70/30% IPA/water mixture at controlled room temperature.
Legal Information
Disclaimer
Certificates of Analysis (COA)
Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.
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