Millistak+® DE stacked discs are
clarification/prefiltration filters that have been specifically developed to
meet the critical needs of the pharmaceutical and biotechnology industries. The
Millistak+® DE filter cells consist of a broad range of controlled porosity
graded density depth media housed in chemically stable polypropylene.
To meet the stringent needs of the biopharmaceutical industry, the
Millistak+® DE filters undergo rigorous testing to ensure high wet tensile
strength, low gravimetric extractables, and low oxidizable substances. The
plastic components and materials meet USP Class VI non-toxicity requirements
for pharmaceutical manufacturing.
The Millistak+® DE stacked disc
filters satisfy application needs in the bio-pharmaceutical market where high
concentrations of colloidal contaminants dictate the need for high surface area
depth media with a positive charge.
Benefits
Monitored gradient density matrix
assures consistent filtration performance
Filter matrix exhibits
positive charge properties to enhance filtration performance
Broad
range of media grades to assure optimal performance
Aqueous extraction contains <0.25 EU/mL as
determined by the Limulus Amebocyte Lysate (LAL) clot test technique
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.
Oxidizable Substances
The effluent of an autoclaved (1 cycle of
30 minutes @ 123 °C) stacked device is negative after a WFI flush of
5 liters per ft2 (50 L/m2) of media surface area
Extractables
Post autoclave (1 cycle of 30 minutes at 123 °C)
and pure water flush of 50 L/m2 (5 L/ft2) of media
surface area. NVR: 3.93–6.43 mg/m2 TOC: 753–1,567 ppb
Indirect Food Additive
All component materials meet the FDA Indirect Food
Additive requirements cited in 21 CFR 177-182.
Sterilization
May be steam sterilized for 3 steam-in-place (SIP)
cycles of 30 minutes @ 123 °C
Sanitization
May be hot water sanitized for 20 cycles using purified
water @ 80 °C for 30 minutes
Conductivity
9-12 µS/cm after a pure water flush of
50 L/m2 (5 L/ft2) of media surface area per
autoclaved (1 cycle of 30 minutes at 123 ºC) 12" 16-stack
device
The new Millistak+ 316L stainless steel filter housings are designed for high-capacity liquid clarification. Offered in multiple sizes to accommodate varying production process volumes, Millistak+ housings complement the removal capacity, dependable performance, and efficiency of our extensive line of Millistak+ and Millistak+ HC filtration cartridges.
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