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KGW6A05TT1

Polysep™ II 1.0/0.5 µm nominal, Opticap® XL Capsule

Name: Polysep™ II 1.0/0.5 µm nominal, Opticap® XL Capsule
Brand: MM

inlet connection diam. 1-1/2 in., Opticap® XL 5, pore size 1.0/0.5 μm, cartridge nominal length 5 in. (12.5 cm)

동의어(들):

Opticap XL5 Polysep II 1.0/0.5 μm 1-1/2 in. TC/TC, Polysep^™ II 1.0/0.5 µm nominal, Opticap^® XL Capsule

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제품정보 (DICE 배송 시 비용 별도)

UNSPSC Code:

23151806

NACRES:

NB.24

eCl@ss:

32031610

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속성

제품 이름

Opticap^® XL 5 CapsuleMedia: Polysep^™ II 1.0 / 0.5 µm Nominal, Chemistry: Mixed Cellulose Esters (MCE)Inlet: 1-1/2 in. Sanitary FlangeOutlet: 1-1/2 in. Sanitary FlangeMax Operating Pressure 80 @ 25 °C

Quality Level

400

material

borosilicate glass fiber (BGF) membrane, mixed cellulose esters (MCE) membrane, 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)

sterility

non-sterile

sterilization compatibility

autoclavable compatible

product line

Opticap^® XL 5

feature

hydrophilic

manufacturer/tradename

Opticap^®

parameter

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., 3.5 bar max. differential pressure (50 psid) at 25 °C, 5.5 bar max. inlet pressure (80 psi) at 23 °C, 80 psig max. inlet pressure

technique(s)

prefiltration: suitable

L

21.6 cm (8.5 in.)

W

4.2 in.

cartridge nominal length

5 in. (12.5 cm)

diam.

14.5 cm (5.7 in.)

filtration area

0.19 m²

inlet connection diam.

1-1/2 in.

inlet to outlet W

21.6 cm (8.5 in.)

outlet connection diam.

1-1/2 in.

impurities

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

gravimetric extractables

≤61 mg/capsule

matrix

Polysep^™ II

pore size

1.0/0.5 μm nominal pore size, 1.0/0.5 μm pore size

fitting

inlet sanitary flange, outlet sanitary flange, (38 mm (1 1/2 in.) Sanitary Flange Inlet and Outlet)

shipped in

ambient

설명

General description

Device Configuration: Capsule

Features and Benefits

Format: Double Layer

Packaging

Double Easy-Open bag

Preparation Note

Sterilization Method
3 autoclave cycles of 30 min @ 121 °C; not in-line steam sterilizable

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).

Analysis Note

Gravimetric Extractables: after a 5 L flush and 24 hours in water at controlled room temperature

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥2 L

Other Notes

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 to the first page of Visual Inspection Guide and introduction section of the Mixed cellulose esters Tech Brief
Storage Statement: Please refer to the Mixed cellulose esters Tech Brief
Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

Replaces: SN1M041A8

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

Legal Information

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

Polysep is a trademark of Sigma-Aldrich Co. LLC

Disclaimer

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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SKU	GTIN
KGW6A05TT1	04053252356131