KGEPG006FH3

Millipore Express^® SHF 0.2µm, Opticap^® XL 600 Capsule

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

• Synonym(s): Opticap XL 600 Millipore Express SHF Gamma Compatible 0.2 μm 3/4 in. TC-9/16 in. HB, Millipore Express^® SHF, Opticap^® XL Capsule
• UNSPSC Code: 23151806
• NACRES: NB.24

Properties

• Product Name: OPTICAP^® XL 600 Capsule Media: MILLIPORE EXPRESS^® SHF 0.2 µm, Chemistry: Hydrophilic Polyethersulfone (PES) Inlet: 3/4 in. Sanitary Flange Outlet: 9/16 in. Hose Barb Max Operating Pressure: 80 psi @ 25 °C
• material: polyester support; polyethersulfone membrane; polypropylene housing; polypropylene vent cap; silicone O-ring; silicone seal
• reg. compliance: meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
• feature: hydrophilic
• manufacturer/tradename: Millipore Express^®
• parameter: 1 bar max. differential pressure (15 psi) at 80 °C; 1 bar max. inlet pressure (15 psi) at 80 °C; 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. differential pressure (80 psi) at 25 °C; 5.5 bar max. inlet pressure (80 psi) at 25 °C; 6.9 bar max. differential pressure (100 psi) at 25 °C (Forward; Intermittent); 6.9 bar max. inlet pressure (100 psi) at 25 °C (Intermittent)
• technique(s): sterile filtration: suitable
• L: 16.5 cm (6.5 in.)
• W: 2.2 in.
• cartridge nominal length: 6.5 in. (16.5 cm)
• diam.: 5.6 cm (2.2 in.)
• filtration area: 0.097 m² (1.046 ft²)
• inlet connection diam.: 3/4 in.
• inlet to outlet W: 16.5 cm (6.5 in.)
• outlet connection diam.: 9/16 in.
• Quality Level: 400
• sterility: non-sterile
• sterilization compatibility: autoclavable compatible; gamma compatible; x-ray compatible
• product line: Opticap^® XL
• impurities: <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• matrix: Millipore Express^® SHF
• pore size: 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

Description

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 3.0 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

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.

General description

Device Configuration: Capsule

Sterile capsules meet current USP and AAMI guidelines for sterility utilizing a validated sterilization cycle.

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.

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).

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