Opticap^?XL1 Clarigard^?

半岛bd体育手机客户端 说明

一般描述

Device Configuration: 取样皿滤膜

包装

Double Easy-Open bag

其他说明

These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
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.

制备说明

This product was manufactured with a media combination which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
Sterilization Method
3 autoclave cycles of 30 min @ 126 °C; not in-line steam sterilizable

分析说明

Gravimetric Extractables: after 24 hours in water at controlled room temperature
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥1 L

法律信息

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

免责声明

EMD Millipore Corporation certifies that this product complies with the European Pressure Equipment Directive, 97/23/EC of 29 May 1997. This product has been classified under Article 3 § 3 of the Pressure Vessel Directive. It has been designed and manufactured in accordance with sound engineering practice to ensure safe use. In compliance with Article 3 § 3 of this Pressure Vessel Directive, this product does not bear the CE mark.

基本信息

eCl@ss

32031690

半岛bd体育手机客户端 性质

质量水平	400
物料	polypropylene polypropylene housing polypropylene support polypropylene vent cap silicone seal
reg. compliance	meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
manufacturer/tradename	Opticap?
参数	1.0 bar max. inlet pressure (15 psi) at 80 ℃ 2.75 bar max. inlet pressure (40 psi) at 60 ℃ 25 ℃ max. inlet temp. 4.8 bar max. differential pressure (70 psid) at 20 ℃ 5.5 bar max. inlet pressure (80 psi) at 23 ℃ 80 psig max. inlet pressure
长度	21.6 cm (8.5 in.)
cartridge nominal length	1 in. (2.5 cm)
直径	10.7 cm (4.2 in.)
inlet connection diam.	3/4 in.
inlet to outlet W	21.6 cm (8.5 in.)
outlet connection diam.	3/4 in.
总尺寸	1 in.
杂质	≤0.25 EU/mL bacterial endotoxins (LAL test, Aqueous extraction) <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
gravimetric extractables	≤10 mg/capsule
基质	Clarigard?
孔径	1.0 μm nominal pore size 1.0 μm pore size
input	sample type liquid
配件	inlet sanitary flange 19 mm ( 3/4 in.) inlet/outlet sanitary flange outlet sanitary flange