CVGL75S01

Durapore^® 0.22 µm, Cartridge

pore size 0.22 μm, cartridge nominal length 5 in. (12.5 cm), Code 7 (2-226; O-rings w/locking-tabs)

• Szinonimák: Durapore Cartridge Filter 5 in. 0.22 μm Code 7
• UNSPSC kód: 23151806
• eCl@ss: 32031690

Tulajdonságok

• Anyagok: PVDF ; polypropylene ; polypropylene support; silicone seal
• Minőségi szint: 400
• szab. megfelelőség: meets EU framework regulation [1935/2004/EC] (all component materials; regarding materials and articles intended to contact food); meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
• sterilitás: non-sterile
• Sterilizálási kompatibilitás: autoclavable compatible; steam-in-place compatible
• termékcsalád: Durapore^®; EMPROVE^® Filter
• Jellemzők: hydrophilic
• gyártó/kereskedő neve: Durapore^®
• Paraméterek: ≤6.6 mL/min air diffusion at 2.75 bar (40 psig) and 23 °C (in water); 0.35 bar max. differential pressure (5 psid) at 135 °C (Forward); 0.35 bar max. inlet pressure (5 psi) at 135 °C (Forward); 1.7 bar max. differential pressure (25 psid) at 80 °C (Forward); 1.7 bar max. inlet pressure (25 psi) at 80 °C (Forward); 25 L/min flow rate at 1.4 bar (ΔP); 3.5 bar max. differential pressure (50 psid) at 25 °C (Reverse); 3.5 bar max. inlet pressure (50 psi) at 25 °C (Reverse); 5.5 bar max. differential pressure (80 psid) at 25 °C (Forward); 5.5 bar max. inlet pressure (80 psi) at 25 °C (Forward)
• technika/technikák: sterile filtration: suitable
• Hosszúság: 5 in.
• Szélesség: 2.7 in.
• patron névleges hossza: 5 in. (12.5 cm)
• Átmérő: 6.9 cm (2.7 in.)
• szűrőfelület: 0.35 m²
• szennyeződések: ≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction); <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• gravimetriás extrahálható anyagok: ≤10 mg/cartridge
• Mátrix: Durapore^®
• pórusméret: 0.22 μm pore size
• bemenet: sample type liquid
• buborékpont: ≥3450 mbar (50 psig), air with water at 23 °C
• patronkód: Code 7 (2-226; O-rings w/locking-tabs)

Leírás

Általános leírás

Device Configuration: Cartridge

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 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.

Elkészítési megjegyzés

Sterilization Method
30 SIP cycles of 30 min @ 135 °C; 30 autoclave cycles of 60 min @ 126 °C

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).

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.

Gravimetric Extractables: after 24 hours in water at controlled room temperature

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥500 mL

Jogi információk

ASTM is a registered trademark of American Society for Testing and Materials

Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany

Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany