Product Name
Millipore Express® SHC, Opticap® XLT Capsule, Opticap® XLT, sterile, inlet connection diam. 1.5 in., pore size 0.5/0.2 μm, cartridge nominal length 30 in. (75 cm)
material
polyester support
polyethersulfone membrane
polypropylene housing
polypropylene vent cap
silicone seal
Quality Level
reg. compliance
meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
sterility
sterile
sterilization compatibility
autoclavable compatible
product line
Opticap® XLT
feature
hydrophilic
manufacturer/tradename
Millipore Express®
parameter
1 bar max. differential pressure (15 psi) at 80 °C
1.0 bar max. inlet pressure (15 psi) at 80 °C
2.1 bar max. differential pressure (30 psi) at 25 °C (Reverse; intermittent)
2.8 bar max. inlet pressure (40 psi) at 60 °C
5.5 bar max. differential pressure (80 psi) at 25 °C
5.5 bar max. inlet pressure (80 psi) at 25 °C
6.9 bar max. differential pressure (100 psi) at 25 °C (Forward; intermittent)
6.9 bar max. inlet pressure (100 psi) at 25 °C (intermittent)
technique(s)
sterile filtration: suitable
cartridge nominal length
30 in. (75 cm)
device L
87.1 cm (34.3 in.)
filter diam.
10.7 cm (4.2 in.)
filtration area
1.63 m2 (17.4 ft2)
inlet connection diam.
1.5 in.
outlet connection diam.
1.5 in.
impurities
<0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
matrix
Millipore Express® SHC
pore size
0.5/0.2 μm pore size
bubble point
≥4000 mbar (58 psig), air with water at 23 °C
fitting
38 mm (1 1/2 in.) inlet sanitary flange
38 mm (1 1/2 in.) outlet sanitary flange
Analysis Note
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
After sterilization and a controlled water flush of 63 L, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64> at 25 °C.
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 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.
Packaging
Preparation Note
3 autoclave cycles of 60 min @ 126 °C; capable of 45 kilogray (4.5 Megarad) gamma exposure; not in-line steam sterilizable
Legal Information
Regulatory 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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