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Millistak+ HC Stacked Disc Filters

Description

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.

Regulatory Compliance

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.

Specifications (return to top)

Materials of Construction
Filter MediaCellulose
Inorganic Filter Aid
Mixed Cellulose Esters
Structural ComponentsPolypropylene
Media Grade
LA1HCG6S260DE/75DE/RW01
LB1HCG6S250DE/75DE/RW01
LA1HCG6S230DE/60DE
Stack Design16 in. diameter, 8-cell
Filtration Area, m21.8
Maximum Differential Pressure, bar (psid)2.1 (30) @ 25 °C; 1 (15) @ 80 °C; 0.2 (3) @ 123 °C
Bacterial Endotoxins<0.25 EU/mL as determined by the LAL test
Component Material ToxicityComponent 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 SubstancesThe effluent of an autoclaved (1 cycle of 30 min @ 123 °C) stacked device meets the requirements for USP sterile water for injection after a WFI flush of 100 L/m2 of media surface area
Gravimetric ExtractablesPost 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 AdditiveAll component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177–182.
Sterilization3 SIP cycles of 30 min @ 123 °C
Sanitization20 cycles of 30 min with hot water @ 80 °C
Conductivity5.3 – 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


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比较 目录编号 说明 数量/包装  
LA1HCG6S2 Millistak+ HC grade A1HC 16 in. diam 8-cell, silicone seal 2 » 添加到购物车
LB1HCG6S2 Millistak+ HC grade B1HC 16 in. diam 8-cell, silicone seal 2 » 添加到购物车
LC0HCG6S2 Millistak+ HC grade C0HC 16 in. diam 8-cell, silicone seal 2 » 添加到购物车
Process Development Kit

比较 目录编号 说明 数量/包装  
MKTHC23HH0 Millistak+ HC Process Development Kit 1 » 添加到购物车


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