Merck
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文件

KRA5A51FF1

Millipore

Opticap XL1 Polygard -CR 0.5 µm 3/4 in.TC/TC

inlet connection diam. 3/4 in., pore size 0.5 μm, cartridge nominal length 1 in. (2.5 cm)

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别名:
Opticap® XL1 Polygard® CR减菌过滤器
eCl@ss:
32031690

物料

polypropylene
polypropylene housing
polypropylene support
polypropylene vent cap
silicone seal

质量水平

管理合规性

meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)

制造商/商品名称

Opticap®

参数

1.0 bar max. inlet pressure (15 psi) at 80 °C
2.75 bar max. inlet pressure (40 psi) at 60 °C
25 °C max. inlet temp.
4.8 bar max. differential pressure (70 psid) at 20 °C
5.5 bar max. inlet pressure (80 psi) at 25 °C
80 psig max. inlet pressure

长度

21.6 cm (8.5 in.)

纯化柱标称长度

1 in. (2.5 cm)

直径

10.7 cm (4.2 in.)

入口接头直径

3/4 in.

入口至出口宽度

21.6 cm (8.5 in.)

出口接头直径

3/4 in.

杂质

≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction)
<0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)

重量萃取物

≤10 mg/capsule

基质

Polygard®-CR

孔径

0.5 μm nominal pore size
0.5 μm pore size

输入

sample type liquid

配件

inlet sanitary flange
19 mm (3/4 in.) inlet/outlet sanitary flange
outlet sanitary flange

一般描述

Polygard® CR products are nominally rated filters designed for particle removal applications in liquids and gases. The graded-density depth structure of Polygard® CR filter media provides maximum filtration capacity, and the all-polypropylene construction offers low extractables levels and broad chemical compatibility.

The KRA5A51FF1 Opticap® XL1Polygard® CR features a pore size of 0.5 μm. This single layer emcapsulated depth filter has a sanitary flange inlet/outlet connection measuring 3/4 in. in diameter.

Opticap XL capsule filters eliminate the time and expense associated with assembling, cleaning, and validating stainless steel housings. The capsule patented design allows unparalleled thermal and hydraulic stress resistance, resulting in reliability, high confidence in the sterility process and improved cleanliness. The unique capsule design with Polygard® CR media minimizes hold-up volume and reduces production losses.

特点和优势

Format: Single Layer

包装

Double Easy-Open bag

其他说明

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

制备说明

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

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

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