|Millistak+® Pod Disposable Depth Filter Performance Guide|
|Application Note: Millistak+ activated carbon for mAb downstream purification (EMD)|
|Article: Selection of clarification methods for improved downstream performance and economics|
|Millistak+® Filter Chemical Compatibility Chart|
|"Schneller und effizienter" (Faster and more efficient)|
Ulrich Hoebel, Key Account Manager for Boehringer Ingelheim & Regional Sales Manager in Central Area
Biotechnica Today, official journal of the Hannover tradeshow Biotechnica, published by the German magazine Laborpraxis, issue October 18 2005, page 9 2005
|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
Millistak+ and Millistak+ HC HousingsDesigned for high-capacity liquid clarification.
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Millistak+® Pod Disposable Depth Filter SystemsHigh performance Pod filters are ideal for primary and secondary clarification in lab, pilot and process scale applications
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Millistak+ HC filters combine two distinct separation technologies to enhance filter capacity and retention - charged depth media (DE grade) and membrane (RW01). Designed for removing whole cells or colloidal particulates in mammalian cell culture applications, Millistak+ HC filters compress multiple stages of downstream bioreactor processes into one efficient step.
Developed to meet the critical needs of the biopharmaceutical industry, Millistak+ HC filters optimize critical cell culture fluid filtration and are ideal for large volume commercial production applications.
Millistak+ HC filters incorporate two graded-density layers of adsorptive depth filter media. Comprised of positively charged Millistak+ DE media, the successively tighter multimedia layers reduce particle loads when cell culture fluids flow through the filter. The more retentive Millistak+ HC filters incorporate an additional layer of cellulose membrane.
Millistak+ HC Media Compresses Clarification Processing
Millistak+ HC's dual-action depth media optimize filtration steps. High debris loads and the wide distribution of particle size in cell culture fluid streams conventionally require individual multiple filtration steps.
Millistak+ HC filter’s unique configuration removes larger particles while smaller, negatively-charged particles are adsorbed by the media’s positively-charged surface. This streamlined technology saves time, lowers costs, and reduces maintenance.
Millistak+ HC filters were designed, developed, and manufactured in accordance with a Quality Management System approved by an accredited registering body to an ISO® 9000 Quality Systems Standard. For traceability and easy identification, each filter is labeled with the product name and identifying characteristics and shipped with a Certificate of Quality. Millistak+ HC filters are supported by a Validation Guide for compliance with regulatory requirements.
|Materials of Construction|
|Filter Media||Cellulose (CL)
Inorganic Filter Aid
Mixed Cellulose Esters (MCE)
|LA1HCG6S2||DE30 / DE60|
|Stack Design||16 in. diameter, 8-cell|
|Filtration Area||1.8 m²|
|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 10 liters per ft2 (100 L/m2) of media surface area|
|Gravimetric Extractables||Post autoclave (1 cycle of 30 minutes at 123 °C) and pure water flush of 100 L/m2 (10 L/ft2) of media surface area.
NVR: 1.50 – 2.02 mg/m2
TOC: 416– 593 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||5.3 – 6.4 µS/cm after a pure water (Type I DI Water) flush of 100 L/m2 (10 L/ft2) of media surface area per autoclaved 16|