|Impact of Design and Selection of Prefilters on Operating Cost|
Honig, Ephraim S., and Perry D. Schwartz; Filtration & Separation (Jan/Feb 1997).
Filtration & Separation (Jan/Feb 1997). 1997
|What are the flushing recommendations for prefilters?||
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.
- 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
|Stack Design||Stack Height, cm (in)||16" Diameter Stack|
|F (6 cell)||19.4 (7.63)||N/A|
|J (9 cell)||19.4 (7.63)||N/A|
|N (13 cell)||27.6 (10.88)||N/A|
|R (16 cell)||27.6 (10.88)||N/A|
|T (16 cell)||27.6 (10.88)||3.47 m²|
|Materials of Construction|
|Filter Media||Cellulose (CL)
Inorganic Filter Aid
|Maximum Differential Pressure, bar (psid)||Forward: 2.07 bar (30 psid) @ 25 °C; 1.03 bar (15 psid) @ 80 °C; 0.21 bar (3 psid) @ 123 °C. Reverse: 0.03 bar (0.5 psid)|
|Bacterial Endotoxins||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|