|Clarification Portfolio Guide|
|Article: Selection of clarification methods for improved downstream performance and economics|
|Millistak+® Filter Chemical Compatibility Chart|
|Reprint: Clarification of vaccines: An overview of filter based technology trends and best practices|
|Millistak+ and Millistak+ HC Housings|
|Millistak+® Depth Filters|
|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?||
|Opticap Capsules with Millistak+ Media|
Millistak+ and Millistak+ HC HousingsDesigned for high-capacity liquid clarification.
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|Biopharmaceutical Manufacturing > Harvest > Clarification > Millistak+® Pod Disposable Depth Filter > Millistak+ Hardware > Lenticular|
Millistak+® clarification/prefiltration stacked disc filters have been specifically developed to meet the critical needs of the pharmaceutical and biotech industries, incorporating a broad range of controlled porosity graded density depth media.
Available media series satisfy most applications needs in the biopharmaceutical market where high concentrations of colloidal contaminant dictate the need for high surface area depth media with a positive charge. Within the CE series, a variety of grades enable the user to choose the filter best suited to his application. Media grades are differentiated by flow characteristics rather than by micron ratings. Nominal retention guidelines are provided but trials in customer fluids are recommended for selection of the optimum filter based on processing conditions. The CE series is suitable for coarse filtration in the 1 to 30 micron range.
- 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
- Media available to fit virtually any filter press
Typical extractable levels have been determined by laboratory analysis utilizing a dynamic flow rinse procedure. Inorganic extractables are quantified by atomic absorption analytical techniques. The results are expressed as milligram per ft2 of media subsequent to the standard recommended flush of 100 L/m2 (10 L/ft2) of media surface area.
|Sodium||3.45 - 4.76|
|Calcium||2.56 - 2.74|
|Potassium||0.17 - 0.91|
|Magnesium||1.19 - 2.03|
|Materials of Construction|
|Filter Media||Cellulose (CL)|
|Maximum Differential Pressure, bar (psid)||Forward: 2.07 bar (30 psid) @ 25 °C; 1.03 bar (15 psid) @ 80 °C|
|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 10 liters per ft2 (100 L/m2) of media surface area|
|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|
|Stack Design||Height||Filtration Area|
|16 in. diameter, 16-cell||27.6 cm (10.88 in.)||3.47 m²|