KEGBG003FF3

Millipore Expresse^™ SPG 0.2 µm, Opticap^® XL Capsule

Opticap^® XL 300, inlet connection diam. 3/4 in., pore size 0.2 μm

• Synonym(s): Millipore Express^® SPG 0.2 µm, Opticap^® XL Capsule, Gamma Phobic Opticap^® XL 300 Express SPG 0.2 sanitary flange
• UNSPSC Code: 23151806
• eCl@ss: 32031690
• NACRES: NB.24

Properties

• Product Name: Opticap^® XL 300 Capsule Media: Millipore Express^™ SPG 0.2 µm, Chemistry: Hydrophobic Polyethersulfone (PES) Inlet: 3/4 in. Sanitary Flange Outlet: 3/4 in. Sanitary Flange
• material: polyethersulfone membrane; polyethylene support; polypropylene housing; silicone O-ring
• Quality Level: 400
• sterility: non-sterile
• Sterilization Compatibility: gamma compatible; x-ray compatible
• product line: Opticap^® XL
• feature: hydrophobic
• manufacturer/tradename: Opticap^®
• parameter: 2.1 bar max. differential pressure (30 psid) at 4-40 °C (Reverse); 60 psid max. differential pressure (4.1 bar) at 4-40 °C (Forward)
• technique(s): gas filtration: suitable
• filtration area: 0.048 m²
• impurities: <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• gravimetric extractables: ≤3 mg
• matrix: Millipore Express^® SPG
• pore size: 0.2 μm pore size
• bubble point: ≥1210 mbar (17.5 psig), air with 70/30% IPA/water at 23 °C
• fitting: 19 mm (3/4 in.) inlet sanitary flange; 19 mm (3/4 in.) outlet sanitary flange
• shipped in: ambient

Description

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.

Gravimetric Extractables: after 24 hours in a 70/30% IPA/water mixture at controlled room temperature

HydroCorr: ≤0.16 mL/min @ 2.6 bar (38 psig)

TOC/Conductivity
After gamma irradiation and three autoclave cycles, the TOC was measured to be equal to or less than 3367 µg/device.

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

Express is a trademark of Merck KGaA, Darmstadt, Germany

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.