Product Name
Durapore® 0.22 µm, Opticap® XL Capsule, Opticap® XL, inlet connection diam. 1/4 in.
material
silicone seal
PVDF membrane
polypropylene housing
polypropylene support
polypropylene vent cap
silicone O-ring
reg. compliance
meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
sterility
non-sterile
sterilization compatibility
autoclavable compatible
feature
hydrophilic
Quality Level
product line
Opticap® XL
manufacturer/tradename
Durapore®
parameter
1.0 bar max. differential pressure (15 psid) at 80 °C (Forward)
1.0 bar max. inlet pressure (15 psi) at 80 °C
3.4 bar max. differential pressure (50 psid) at 25 °C (Reverse; intermittent)
5.5 bar max. differential pressure (80 psid) at 25 °C (Forward)
5.5 bar max. inlet pressure (80 psi) at 25 °C
technique(s)
sterile filtration: suitable
device L
4 in. (10 cm)
filtration area
0.19 m2
inlet connection diam.
1/4 in.
inlet to outlet W
17.8 cm (7.0 in.)
outlet connection diam.
1/4 in.
impurities
<0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
gravimetric extractables
≤10 mg/capsule
matrix
Durapore®
pore size
0.22 μm
input
sample type liquid
bubble point
≥3450 mbar (50 psig), air with water at 23 °C
fitting
6 mm (1/4 in.) NPT (Inlet and Outlet)
compatibility
for use with AFS® Essential
for use with AFS®
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Analysis Note
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
Disclaimer
General description
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.
Packaging
Preparation Note
3 autoclave cycles of 60 min @ 126 °C; not in-line steam sterilizable
Legal Information
Certificates of Analysis (COA)
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Global Trade Item Number
| SKU | GTIN |
|---|---|
| KVGLA04NN3 | 04053252559358 |
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