Millistak+® HC Pro
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Categorie
| Biopharmaceutical Manufacturing > Harvest > Clarification > Millistak+® Pod Disposable Depth Filter > Millistak+ Hardware |
Millistak+® HC Pro (high capacity synthetic media) is a family of synthetic depth filters providing a cleaner and more consistent depth filtration media over current diatomaceous earth (DE) and cellulose (CE) based filter offerings. Multiple media grades are available for primary and secondary clarification as well as downstream filtration applications.
Features & Benefits
Synthetic materials of construction
- Reduce TOC extractables and pre-use flush volume requirements by 50%
- No beta glucans to interfere with limulous amoebocyte lysate (LAL) testing for bacterial endotoxins
- Lot to lot consistency for successful development and implementation of robust clarification processes
Depth filter media formulation & design
- Provide as much as two times the filtration capacity with equivalent filter retention properties over commercial DE-based benchmarks
- Improved HCP impurity clearance
Disposable Pod device
- Flexible, modular format offers scalability from 5 to 12,000 liters or more
- Robust device format; easy to use and set up
The Emprove® Program
The Emprove® Program complements the product portfolio through
- Comprehensive documentation to support qualification, risk assessment and process optimization needs.
- Consolidation of product specific testing, quality and regulatory information to simplify compliance requirements.
- Convenient 24/7 access to up-to-date product information.
| Media Grade | D0SP | C0SP | X0SP |
| Surface Area | 23 cm2 | 23 cm2 | 23 cm2 |
| Materials of Construction | |||
| Depth Filter Media | Silica Filter Aid with Polyacrylic Fiber | ||
| Filter non-woven | Polypropylene | N/A | N/A |
| Pod Housings | Glass Filled Polypropylene | ||
| Inlet, Vent and Outlet Connections | Female Luer | ||
| Pod (Device) dimensions | |||
| Length | 3.5" (8.9 cm) | ||
| Height | 2.6" (6.6 cm) | ||
| Thickness | 1.6” (4.1 cm) | ||
| Maximum Operating Pressure | 50 psid (3.5 bar) @ ≤40°C | ||
| Maximum Differential Pressure | |||
| Forward | 30 psid (2.1 bar) @ 40 °C | ||
| Reverse | 15 psid (1.0 bar) @ 40 °C | ||
| Sterilization | Sterilization 2 cycles of 60 minutes at 123 °C 1 cycle of 60 minutes at 123 °C | ||
| Toxicity | All component materials meet the requirements of the current USP <88> biological reactivity test for class VI plastics. | ||
| Bacterial Endotoxin | Bacterial Endotoxin < 0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test | ||
| Pressure Equipment Directive 2014/68/EU3 | Devices and associated holders are designed and manufactured in accordance with the sound engineering practices (SEP) cited in Article 4(3) of 2014/68/EU | ||