KVVLG1TTH1

Durapore^® 0.1 µm, Opticap^® XLT Capsule

inlet connection diam. 1.5 in., Opticap^® XLT 10, cartridge nominal length 10 in. (25 cm)

• Sinônimo(s): Opticap Gamma Compatible Sterilizing Grade XLT10 Durapore 0.1 μm 1-1/2 in. TC-5/8 in. HB, Durapore^® 0.1 µm, Opticap^® XLT Capsule
• UNSPSC Code: 23151806

Propriedades

• Nome do produto: Cápsula Durapore^® 0,1 µm, Opticap^® XLT, Chemistry: Hydrophilic Polyvinylidene Fluoride (PVDF)Inlet: 1-1/2 in. Sanitary FlangeOutlet: 5/8 in. Hose BarbT-lineMax Operating Pressure: 80 psi @ 25 °C
• material: PVDF , polyester support, polyethylene support, polypropylene (gamma-stable), polypropylene housing, polypropylene vent cap, silicone seal
• reg. compliance: meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
• Quality Level: 400
• sterility: non-sterile
• sterilization compatibility: gamma compatible
• product line: Opticap^® XLT 10
• feature: gamma compatible, hydrophilic
• manufacturer/tradename: Opticap^®
• parameter: ≤21.1 mL/min air diffusion at 3.9 bar (56 psig) and 23 °C (in water), 1.0 bar max. inlet pressure (15 psi) at 80 °C, 1.7 bar max. differential pressure (25 psid) at 80 °C (Forward), 2.8 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 (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, 80 psig max. inlet pressure
• technique(s): sterile filtration: suitable
• L: 37.6 cm (14.8 in.)
• W: 6.9 in.
• cartridge nominal length: 10 in. (25 cm)
• diam.: 10.7 cm (4.2 in.)
• filtration area: 0.73 m²
• inlet connection diam.: 1.5 in.
• inlet to outlet W: 17.5 cm (6.9 in.)
• outlet connection diam.: 5/8 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: ≤25 mg/capsule
• matrix: Durapore^®
• pore size: 0.1 μm
• input: sample type liquid
• bubble point: ≥4830 mbar (70 psig), air with water at 23 °C
• fitting: 1/4 in. drain/vent hose barb (with double O-ring Seal), (38 mm (1 1/2 in.) Sanitary Flange Inlet and 16 mm (5?8 in.) Hose Barb Outlet)

Descrição

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; capable of 45 kilogray (4.5 Megarad) gamma exposure; 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.