KPHLS3TTH1

Opticap^® XL Capsule Filter

cartridge nominal length 34.3 in. (87.1 cm), filter diam. 4.2 in. (10.7 cm)

Properties

• 物料: polypropylene filter; polypropylene housing; polypropylene support (Gamma-Stable); silicone seal
• 质量水平: 400
• reg. compliance: FDA 21CFR177-182 (all component materials)
• 特点: hydrophilic
• manufacturer/tradename: Opticap^®
• 参数: ≤45.0 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
• cartridge nominal length: 34.3 in. (87.1 cm)
• device L: 87.1 cm (34.3 in.)
• device size: 30 in.
• 过滤器直径: 4.2 in. (10.7 cm)
• filter filtration area: 1.86 m²
• inlet connection diam.: 1-1/2 in.
• inlet to outlet width: 87.1 cm (34.3 in.)
• outlet connection diam.: 5/8 in.
• 杂质: ≤0.25 EU/mL bacterial endotoxins (LAL test, aqueous extraction); <0.25 EU/mL bacterial endotoxins (LAL test, sample aqueous extraction)
• 基质: Durapore^®
• 孔径: 0.45 μm pore size
• bubble point: ≥1930 mbar (28 psig), air with water at 23 °C
• 配件: 16 mm (5/8 in.) fitting (hose barb outlet); 38 mm (1 1/2 in.) fitting (sanitary flange inlet); 1/4 in. fitting (vent/drain hose barb with double O-ring seal)

Description

一般描述

Device Configuration: Capsule

制备说明

Sterilization Method:
Minimum sterilization up to 25 kGy. 3 autoclave cycles of 60min at 3°C; not in-line steam sterilizable

分析说明

Gravimetric Extractables: ≤ 25 mg per capsule after 24 hours in water at controlled room temperature.

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 4500 mL

其他说明

Directions for Use:

• 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

法律信息

Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany

OPTICAP is a registered trademark of Merck KGaA, Darmstadt, Germany