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Key Documents

KR10A10FF1

Millipore

Opticap® XL10 Polygard® CR

inlet connection diam. 3/4 in., pore size 10.0 μm, cartridge nominal length 10 in. (25 cm)

Sinónimos:

Opticap® XL10 Polygard®-CR 10.0 µm 3/4 in. TC/TC

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About This Item

Código UNSPSC:
23151806

Materiales

polypropylene
polypropylene housing
polypropylene support
polypropylene vent cap
silicone seal

Nivel de calidad

cumplimiento norm.

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

fabricante / nombre comercial

Opticap®

Parámetros

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

Longitud

33.5 cm (13.2 in.)

longitud nominal del cartucho

10 in. (25 cm)

Diámetro

10.7 cm (4.2 in.)

diám. conexión a entrada

3/4 in.

An entrada a salida

33.5 cm (13.2 in.)

diám. conexión a salida

3/4 in.

impurezas

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

extraíbles gravimétricos

≤55 mg/capsule

matriz

Polygard®-CR

tamaño de poro

10.0 μm nominal pore size
10.0 μm pore size

entrada

sample type liquid

Adaptador

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

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Descripción general

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 KR10A10FF1 Opticap® XL10Polygard® CR features a pore size of 10.0 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.

Características y beneficios

Format: Single Layer

Envase

Double Easy-Open bag

Otras notas

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

Nota de preparación

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

Nota de análisis

Gravimetric Extractables: after 24 hours in water at controlled room temperature
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥5 L

Información legal

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

Cláusula de descargo de responsabilidad

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.

Certificados de análisis (COA)

Busque Certificados de análisis (COA) introduciendo el número de lote del producto. Los números de lote se encuentran en la etiqueta del producto después de las palabras «Lot» o «Batch»

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