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Merck
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KHGEG015FB3

Millipore Express® SHC 0.5/0.2µm, Opticap® XL 150 Capsule

Fittings 3/4 in. TC- 9/16 in. HB with Bell, Gamma Compatible

Synonym(s):

Opticap Gamma Compatible XL 150 Millipore Express SHC 0.5/0.2 m 3/4 in. TC-9/16 in. HB with Bell

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About This Item

UNSPSC Code:
23151806

Key Documents

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Product Name

Millipore Express® SHC, Opticap® XL Capsule, Opticap® XL, pore size 0.5/0.2 μm

material

polyester support
polyethersulfone membrane
polypropylene housing
silicone O-ring

Quality Level

400

reg. compliance

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

sterility

non-sterile

Sterilization Compatibility

autoclavable compatible
gamma compatible
x-ray compatible

product line

Opticap® XL

feature

hydrophilic

manufacturer/tradename

Millipore Express®

parameter

1.0 bar max. differential pressure (15 psid) at 80 °C
1.0 bar max. inlet pressure (15 psi) at 80 °C
100 psi max. inlet pressure (6.9 bar) at 23 °C (intermittent)
2.1 bar max. differential pressure (30 psi) at 25 °C (Reverse; intermittent)
2.8 bar max. inlet pressure (40 psi) at 60 °C
5.5 bar max. inlet pressure (80 psid) at 25 °C
6.9 bar max. differential pressure (100 psid) at 25 °C (Forward; intermittent)
80 psi max. differential pressure (5.5 bar) at 25 °C

device L

11.4 cm (4.5 in.)

filter diam.

5.6 cm (2.2 in.)

filtration area

0.014 m2 (0.155 ft2)

impurities

≤0.25 EU/mL bacterial endotoxins (LAL test, Aqueous extraction)
<0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)

matrix

Millipore Express® SHC

pore size

0.5/0.2 μm pore size

bubble point

≥4000 mbar (58 psig), air with water at 23 °C

fitting

19 mm (3/4 in.) inlet sanitary flange
14 mm (9/16 in.) outlet hose barb (with filling bell)

Related Categories

General description

Device Configuration: Capsule

Packaging

Double Easy-Open bag

Preparation Note

Sterilization Method
Gamma compatible to 45 kGy; 3 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable
This product was manufactured with a Millipore Express® 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.
TOC/Conductivity
After sterilization and a controlled water flush of 1.0 L, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64> at 25 °C.
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 installation section of OPTICAP® XL Capsules and OPTICAP® XLT Capsules 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
MILLIPORE EXPRESS 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.

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’.

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