产品名称
Opticap® XLT30 Polygard过滤器®, inlet connection diam. 1.5 in., Chemistry: Polypropylene (PP)Inlet: 1-1/2 in. Sanitary FlangeOutlet: 1-1/2 in. Sanitary FlangeT-lineMax Operating Pressure: 80 psi @ 25 °C, pore size 10.0 μm, cartridge nominal length 30 in. (75 cm)
material
polypropylene
reg. compliance
meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
Quality Level
manufacturer/tradename
Opticap®
parameter
25 °C max. inlet temp., 80 psig max. inlet pressure
cartridge nominal length
30 in. (75 cm)
inlet connection diam.
1.5 in.
outlet connection diam.
1.5 in.
impurities
<0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
gravimetric extractables
≤165 mg/capsule
matrix
Polygard®-CN
pore size
10.0 μm nominal pore size, 10.0 μm pore size
input
sample type liquid
fitting
inlet sanitary flange, outlet sanitary flange
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General description
Device Configuration: 取样皿滤膜
T-line/Gauge Port: T-line
Analysis Note
Gravimetric Extractables: after 24 hours in water at controlled room temperature
Other Notes
Directions for Use
- Organism Retention: Microorganism reduction
- 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.
These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
Legal Information
OPTICAP is a registered trademark of Merck KGaA, Darmstadt, Germany
POLYGARD is a registered trademark of Merck KGaA, Darmstadt, Germany
法规信息
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