|The science of managing change for filters|
|Application Note: Generic Process of Virus-Like Particle (VLP) Based Vaccine Manufacturing|
Ficha de dados
|Visão geral das referências|
|"Millipore, partenaire idéal pour la stabilisation des Grands Vins" (Millipore, partner of choice for Great Wines Stabilization)|
Jany Boeuf, Application Specialist and F&B Sales Support for France in collaboration with Bruno Sapin from Hygiatech, French distributor; La Revue des Oenologues (French magazine for oenology), issue January 2005, page 77
La Revue des Oenologues (French magazine for oenology), issue January 2005, page 77 2005
Famílias de produtos
Opticap XL Disposable Capsule Filters with Clarigard MediaOpticap XL capsule filters eliminate the time and expense associated with assembling, cleaning, and validating stainless steel housings.
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|Biopharmaceutical Manufacturing > Downstream Processing > Clarification > Clarisolve Depth Filters > Clarigard Filter|
Clarigard® filters' 99.99% retention rating characteristic makes them ideal for the protection of critical downstream process steps such as membrane filters or chromatography columns. The graded-density depth structure of Clarigard filter media provides maximum filtration capacity, and the all-polypropylene construction offers low extractables levels and broad chemical compatibility.
The 0.2 µm and 0.3 µm filters will easily extend the capacity of sterilizing-grade filters. Clarigard high-performance prefilters consistently produce a 1–2 log bio-burden reduction.
Clarigard cartridge filters provide high throughput with minimal differential pressure. Cartridges are robust, strong, resilient and are designed to withstand multiple steam-in-place cycles.
- Protein processing
- Plasma fractions
Undissolved Constituent Removal
- Cell culture media
- Buffer salts
Carbon Fine Removal
- Carbon beds in water processing
- Powdered carbon in chemical synthesis
- Dust, rust and other solids
Clarigard filters are designed, developed, and manufactured in accordance with a Quality Management System approved by an accredited registering body to an ISO® 9000 Quality Systems Standard and are shipped with a Certificate of Quality. Each cartridge filter is supported by a Validation Guide for compliance with regulatory requirements.
For traceability and easy identification, each filter is marked with identifying characteristics.
Multiple Formats Available
Clarigard filters are available in two formats, five pore sizes, and multiple configurations that vary by filtration area and the type of inlet/outlet connection. Small scale filter capsules are available as a selection tool when evaluating several media configurations for use in clarifying process fluids. These devices have been developed to minimize hold-up volume when evaluating multiple media configurations. Small scale filter capsules are available as a selection tool when evaluating several media configurations for use in clarifying process fluids. These devices have been developed to minimize hold-up volume when evaluating multiple media configurations.
|Per 10-inch Cartridge|
|Materials of Construction|
|Filter medium||Polypropylene (PP)|
|Seal Material - Code F||Polyethylene (PE)|
|Seal Material - Code P||Silicone (SI)|
|Maximum Differential Pressure, bar (psid)||4.8 bar (70 psid) @ 25 °C|
|Gravimetric Extractables||≤10 mg after 24-h soak in water|
|Oxidizable Substances||Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥3 L|
|Bacterial Endotoxins||Aqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test|
|Sterilization||10 autoclave cycles or SIP @ 126 °C for 30 min|
|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.|
|Good Manufacturing Practices||These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.|
|Indirect Food Additive||All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182.|
Typical Clean Water Flow Rate vs Pressure Drop
Cartridge Legends Refer to Pore Size (nominal):
D002 = 0.2 µm
D003 = 0.3 µm
D005 = 0.5 µm
D010 = 1.0 µm
D030 = 3.0 µm