KHGES05HH1

Millipore Express^® SHC, Opticap^® XL Capsule

sterile, Opticap^® XL 5, inlet connection diam. 9/16 in., pore size 0.5/0.2 μm, cartridge nominal length 5 in. (12.5 cm)

• Szinonimák: Opticap Sterile XL 5 Millipore Express SHC 0.5/0.2 μm 9/16 in. HB/HB
• UNSPSC kód: 23151806
• eCl@ss: 32031690

Tulajdonságok

• material: polyester support; polyethersulfone membrane; polypropylene ; polypropylene housing; polypropylene vent cap; polysulfone ; silicone seal
• Minőségi szint: 400
• szab. megfelelőség: meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
• sterilitás: irradiated; sterile
• termékcsalád: Opticap^® XL 5
• Jellemzők: hydrophilic
• gyártó/kereskedő neve: Millipore Express^®
• parameter: ≤14 mL/min air diffusion at 2.8 bar (40 psig) and 23 °C ( in water); 1.0 bar max. differential pressure (15 psid) at 80 °C (Forward); 1.0 bar max. inlet pressure (15 psi) at 80 °C; 100 psi max. differential pressure (6.9 bar) (intermittent); 2.1 bar max. differential pressure (30 psid) at 25 °C (Reverse; intermittent); 2.75 bar max. inlet pressure (40 psi) at 60 °C; 5.5 bar max. differential pressure (80 psid) at 25 °C (Forward); 5.5 bar max. inlet pressure (80 psi) at 25 °C; 6.9 bar max. differential pressure (100 psid) at 25 °C (Forward; intermittent); 6.9 bar max. inlet pressure (100 psi) at 25 °C (intermittent); 80 psi max. differential pressure (5.5 bar) (continuous); 80 psig max. inlet pressure
• technika/technikák: sterile filtration: suitable
• Hosszúság: 21.6 cm (8.5 in.)
• patron névleges hossza: 5 in. (12.5 cm)
• Átmérő: 10.7 cm (4.2 in.)
• szűrőfelület: 0.24 m²
• bemeneti csatl. átmérője: 9/16 in.
• bemenettől kimenetig Sz: 21.6 cm (8.5 in.)
• kimeneti csatl. átmérője: 9/16 in.
• szennyeződések: ≤0.25 EU/mL (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
• buborékpont: ≥4000 mbar (58 psig), air with water at 23 °C
• szerelvény: 1/4 in. drain/vent hose barb (with double O-ring seal); inlet hose barb; outlet hose barb; (14 mm (9/16 in.) Hose Barb Inlet and Outlet)

Leírás

Általános leírás

Device Configuration: Capsule

Kiszerelés

Double Easy-Open bag

Egyéb megjegyzések

These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.

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.

Elkészítési megjegyzés

Sterilization Method
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).

Analízis megjegyzés

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 9.5 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 ≥2 L

Jogi információk

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

Jogi nyilatkozat

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.