Durapore 0.65 µm hydrophilic cartridge filters are manufactured from polyvinylidene fluoride (PVDF) membrane with polypropylene components and a cellulose ester prefilter (RW19) providing high flow rates, multiple steamability and low gravimetric extractables. They also exist without prefilter layer.
Durapore cartridges are 100% integrity tested during manufacturing to guarantee product performance.
The Durapore 0.65 µm hydrophilic cartridge will remove particles and micro organisms from aqueous streams. These cartridges function effectively as a prefilter to sterilizing grade membranes and the prefilter layer has high dirt holding capacity.
The version without prefilter layer provides faster flow rates, increased steamability, lower extractables and lower particle shedding. This cartridge is intended for applications where high flow rates are critical, where prefiltration is either unnecessary or already present at an earlier point in the process, or where protein binding must be minimized.
Typical applications include:
- Tissue culture media
- Prefiltration to final filters
- WFI filtration
|Per 10-inch Cartridge
|Per 10-inch Cartridge
|Materials of Construction|
|Filter||Polyvinylidene Fluoride (PVDF)||Polyvinylidene Fluoride (PVDF)|
|RW Prefilter Layer||Mixed Cellulose Esters (MCE)|
|O-rings||Silicone (SI)||Silicone (SI)|
|Filtration Area||0.69 m²||2.07 m²|
|Maximum Differential Pressure, bar (psid)||Forward: 5.5 bar (80 psid) @ 25 °C; 1.7 bar (25 psid) @ 80 °C; 0.35 bar (5 psid) @ 121 °C. Reverse: 1.7 bar (25 psid) @ 25 °C|
|Bacterial Endotoxins||Aqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test|
|Gravimetric Extractables||The extractables level was equal to or less than 45 mg per 10-inch cartridge after 24 hours in water at controlled room temperature.||The extractables level was equal to or less than 20 mg per 10-inch cartridge after 24 hours in water at controlled room temperature.|
|Oxidizable Substances||Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥1 L|
|Sterilization||8 SIP cycles of 30 min or 8 autoclave cycles of 60 min @ 121 °C||30 SIP cycles of 30 min @ 135 °C; 30 autoclave cycles of 60 min @ 126 °C|
|Bubble Point at 23 °C||≥965 mbar (14 psig) air with water|
|Air Diffusion at 23 °C||≤10 mL/min @ 620 mbar (9 psig) in water|
|Component Material Toxicity||Component materials meet the criteria of the USP <88> Reactivity Test for Class VI Plastics. These products meet the requirements of the USP <88> Safety Test, utilizing a 0.9% sodium chloride extraction.|
|Good Manufacturing Practices||These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.|
|Non-Fiber Releasing||Component materials meet the "non-fiber releasing" criteria as defined in 21 CFR 210.3 (b) (6).|
|Indirect Food Additive||All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182.|