Skip to Content
Merck

Key Documents

View All Documentation

KGW6A3TTT1

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

Opticap® XLT 30, inlet connection diam. 1.5 in., pore size 1.0/0.5 μm, cartridge nominal length 30 in. (75 cm)

Synonym(s):

Opticap XLT30 Polysep II 1.0/0.5 μm 1-1/2 in. TC, Polysep™ II 1.0/0.5 µm nominal, Opticap® XLT Capsule

Sign In to View Organizational & Contract Pricing.

Select a Size

Change View

About This Item

eCl@ss:
32031610
UNSPSC Code:
23151806
Technical Service
Need help? Our team of experienced scientists is here for you.
Let Us Assist

Product Name

Opticap® XLT 30 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 FlangeT-lineMax Operating Pressure: 80 psi @ 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® XLT 30

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

87.1 cm (34.3 in.)

cartridge nominal length

30 in. (75 cm)

filtration area

1.38 m2

inlet connection diam.

1.5 in.

inlet to outlet W

15.2 cm (6.0 in.)

outlet connection diam.

1.5 in.

impurities

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

gravimetric extractables

≤435 mg/capsule

matrix

Polysep™ II

pore size

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

input

sample type liquid

fitting

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

General description

Device Configuration: Capsule
T-line/Gauge Port: T-line

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 15 L flush and 24 hours in water at controlled room temperature
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥15 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.
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

Still not finding the right product?

Explore all of our products under Opticap® XLT 30 CapsuleMedia: Polysep™ II 1.0 / 0.5 µm Nominal

Storage Class

11 - Combustible Solids

Regulatory Listings

Regulatory Listings are mainly provided for chemical products. Only limited information can be provided here for non-chemical products. No entry means none of the components are listed. It is the user’s obligation to ensure the safe and legal use of the product.

Substances Subject to be Indicated Names

ishl_indicated

Substances Subject to be Notified Names

ishl_notified

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

Already Own This Product?

Find documentation for the products that you have recently purchased in the Document Library.

Visit the Document Library

Global Trade Item Number

SKUGTIN
KGW6A3TTT104053252300097