Skip to Content
Merck
CN

Key Documents

View All Documentation

KVGLA1THH1

Durapore® 0.22 µm, Opticap® XLT Capsule

Opticap® XLT

Synonym(s):

Opticap XLT10 Durapore 0.22 m 5/8 in. HB/HB, Durapore® 0.22 µm, Opticap® XLT Capsule

Sign In to View Organizational & Contract Pricing.

Select a Size

Change View

About This Item

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

Product Name

Opticap® XLT 10 CapsuleMedia: Durapore® 0.22 µm, Chemistry: Hydrophilic Polyvinylidene Fluoride (PVDF)Inlet: 5/8 in. Hose BarbOutlet: 5/8 in. Hose BarbT-line Max Operating Pressure: 80 psi @ 25 °C

Quality Level

400

material

silicone seal, PVDF membrane, polypropylene housing, polypropylene support, polypropylene vent cap, silicone O-ring

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

feature

hydrophilic

manufacturer/tradename

Durapore®

parameter

1.0 bar max. differential pressure (15 psid) at 80 °C (Forward), 1.0 bar max. inlet pressure (15 psi) at 80 °C, 3.4 bar max. differential pressure (50 psid) at 25 °C (Reverse; intermittent), 5.5 bar max. differential pressure (80 psid) at 25 °C (Forward), 5.5 bar max. inlet pressure (80 psi) at 23 °C

technique(s)

sterile filtration: suitable

device L

10 in. (25 cm)

filtration area

0.69 m2

impurities

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

gravimetric extractables

≤25 mg/capsule

matrix

Durapore®

pore size

0.22 μm

input

sample type liquid

bubble point

≥3450 mbar (50 psig), air with water at 23 °C

fitting

16 mm (5/8 in.) inlet hose barb, 16 mm (5/8 in.) outlet hose barb

General description

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

Packaging

Double Easy-Open bag

Preparation Note

Sterilization Method
3 autoclave cycles of 60 min @ 126 °C; not in-line steam sterilizable
This product was manufactured with a Durapore® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).

Analysis Note

Bacterial Retention
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
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

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 Wetting Instructions for Filter Units with Durapore® Membrane user guide
  • Storage Statement: Store in dry location
  • 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

ASTM is a registered trademark of American Society for Testing and Materials
Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany
OPTICAP is a registered trademark of Merck KGaA, Darmstadt, Germany

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.

Still not finding the right product?

Explore all of our products under Opticap® XLT 10 CapsuleMedia: Durapore® 0.22 µm

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
KVGLA1THH104053252570940