KPHLS10HH1
Durapore® 0.45 µm, Opticap® XL Capsule
Opticap® XL 10, cartridge nominal length 13.2 in. (33.5 cm), filter diam. 4.2 in. (10.7 cm)
material
polyester support
polyethylene support
polypropylene filter
polypropylene housing
silicone outer O-ring
silicone-coated EPDM rubber lead O-ring
Quality Level
reg. compliance
FDA 21CFR177-182 (all component materials)
sterility
sterile; irradiated
product line
Opticap® XL 10
feature
hydrophilic
manufacturer/tradename
Opticap®
parameter
≤15.0 mL/min air diffusion at 3.9 bar (56 psig) and 23 °C (in water)
1 bar max. inlet pressure (15 psi) at 80 °C
2.1 bar max. differential pressure (30 psid) at 4-40 °C (Reverse:)
2.8 bar max. inlet pressure (40 psi) at 60 °C
25 °C max. inlet temp.
4.1 bar max. differential pressure (60 psid) at 25 °C (Forward:)
5.5 bar max. inlet pressure (80 psi) at 23 °C
80 psig max. inlet pressure
technique(s)
bioburden reduction: suitable
cartridge nominal length
13.2 in. (33.5 cm)
device L
33.5 cm (13.2 in.)
device size
10 in.
filter diam.
4.2 in. (10.7 cm)
filter filtration area
0.62 m2
inlet connection diam.
9/16 in.
inlet to outlet width
33.5 cm (13.2 in.)
outlet connection diam.
9/16 in.
impurities
≤0.25 EU/mL bacterial endotoxins (LAL test, aqueous extraction)
<0.25 EU/mL bacterial endotoxins (LAL test, sample aqueous extraction)
matrix
Durapore®
pore size
0.45 μm pore size
bubble point
≥1930 mbar (28 psig), air with water at 23 °C
fitting
1/4 in. fitting (vent/drain hose barb with double O-ring seal)
(14 mm (9/16 in.) Hose Barb Inlet and Outlet)
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General description
Preparation Note
Gamma compatible to 40 kGy. 3 autoclave cycles of 60min at 126°C; not in-line steam sterilizable
This product was manufactured with a Durapore® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21CFR210.3(b)(6).
Analysis Note
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 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
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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