Optiseal Cartridge Filters with 0.45 µm Hydrophilic Durapore Membrane

Description

Optiseal cartridge filters feature a revolutionary cartridge-to-housing sealing mechanism and pleated configuration, resulting in maximum sterility assurance and economical performance. Optiseal filters are designed for pharmaceutical applications, removing particles and microorganisms from liquids and gases. They are made with Millipore-patented Durapore PVDF membranes, providing high flow rates and throughputs, low extractables, broad chemical compatibility and the lowest protein binding of any membrane available.

For traceability and easy identification, each Optiseal cartridge is labelled with its lot number, serial number, pore size and abbreviated catalogue number. Each unit is 100% integrity tested during manufacturing to assure integrity.

Typical Applications

The Optiseal cartridge filters with 0.45 µm hydrophilic Durapore membrane will remove particles and micro organisms from aqueous liquid streams.

The prefilter layer provides superior throughput with solutions containing hard or colloidal particles, such as dextrose. The cartridge can be used for bioburden reduction in large volume parenteral (LVP) applications prior to terminal sterilization, redundantly in difficult-to-filter situations, or as a prefilter to a sterilizing grade filter.

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.

Specifications (return to top)

	Optiseal Cartridge with Prefilter Layer	Optiseal Cartridge without Prefilter Layer
Materials of Construction
Filter	Hydrophilic PVDF	Hydrophilic PVDF
Prefilter Layer	Mixed cellulose esters
O-ring	Silicone	Silicone
Connections	Double O-rings (2-123) with hold-down tabs	Double O-rings (2-123) with hold-down tabs
Filtration Area, m2	0.18	0.18
Maximum Differential Pressure, bar (psid)	Forward: 5.5 (80) @ 25 °C; 3.5 (50) @ 80 °C; 0.35 (5) @ 121 °C. Reverse: 3.5 (50) @ 25 °C	Forward: 5.5 (80) @ 25 °C; 3.5 (50) @ 80 °C; 0.35 (5) @ 121 °C. Reverse: 3.5 (50) @ 25 °C
Bacterial Endotoxins	<0.5 EU/mL as determined by the LAL test	<0.5 EU/mL as determined by the LAL test
Gravimetric Extractables	≤15 mg after 24-h soak in water	≤10 mg after 24-h soak in water
Oxidizable Substances	Will meet the USP Oxidizable Substances Test requirements after a water flush of ≤500 mL	Will meet the USP Oxidizable Substances Test requirements after a water flush of ≤500 mL
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.
Sterilization	10 autoclave cycles or SIP @ 121 °C for 30 min	30 SIP cycles of 30 min @ 135 °C; 10 autoclave cycles of 30 min @ 126 °C
Integrity Tests
Bubble Point at 23 °C	≥1930 mbar (28 psig) air with water	≥1930 mbar (28 psig) air with water
Air Diffusion at 23 °C	≤4 mL/min @ 1.5 bar (22 psig) in water	≤4 mL/min @ 1.5 bar (22 psig) in water

Typical Water Flow Rate

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