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Key Documents

KR01A05FF1

Millipore

Opticap XL5 Polygard -CR 1.0 µm 3/4 in.TC/TC

inlet connection diam. 3/4 in., pore size 1.0 μm, cartridge nominal length 5 in. (12.5 cm)

同義詞:

Opticap® XL5 Polygard® CR减菌过滤器

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About This Item

分類程式碼代碼:
23151806

材料

polypropylene
polypropylene housing
polypropylene support
polypropylene vent cap
silicone seal

品質等級

法律遵循

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

製造商/商標名

Opticap®

參數

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

長度

21.6 cm (8.5 in.)

柱標稱長度

5 in. (12.5 cm)

直徑

10.7 cm (4.2 in.)

入口接頭直徑

3/4 in.

入口到出口寬度

21.6 cm (8.5 in.)

出口接頭直徑

3/4 in.

雜質

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

重量法萃取物

≤30 mg/capsule

基質

Polygard®-CR

孔徑

1.0 μm nominal pore size
1.0 μm pore size

輸入

sample type liquid

接頭

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

一般說明

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 KR01A05FF1 Opticap® XL5Polygard® CR features a pore size of 1.0 μm. This single layer capsule 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.

特點和優勢

Format: Single Layer

包裝

Double Easy-Open bag

其他說明

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

準備報告

Sterilization Method
3 autoclave cycles of 30 min @ 126 °C; not in-line steam sterilizable

分析報告

Gravimetric Extractables: after 24 hours in water at controlled room temperature
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥2.5 L

法律資訊

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

免責聲明

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.

分析證明 (COA)

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