Material Qualification Dossier
|The science of managing change for filters|
|Application Note: Integrity Test Troubleshooting - Beyond Rewet and Retest|
|Establishing Product Specific Bubble Point Specifications For Sterilizing-Grade (0.22 µm) Durapore® Filters|
|Filter Integrity Test Methods|
|Millidisk® Cartridges and Millipak® Disposable Capsules (MilliporeSigma)|
|Sanitary Millidisk® Filter Housings|
|What is the compatibility of Durapore with high pH solutions?||The upper recommended pH limit for Durapore membranes is 10. At pH >10, the hydrophilization layer of the membrane may become subject to hydrolysis. The extent of hydrolysis is a function of time, temperature , concentration and time of exposure. Upon exposure to high pH, the hydrophylization layer can swell which could result in a loss of permeability or flux. The hydrolysis of the hydrophilic layer will also lead to increased extractables from the membrane.|
|What are Millipore's general recommendations for filtering high pH solutions?||For applications involving pH > 10, Millipore recommends the use or our PES membranes Express SHF or Express SHC. For information on these filters :
Express SHF: http://www.millipore.com/catalogue.nsf/docs/C8873
Express SHC: http://www.millipore.com/catalogue.nsf/docs/C9146
|How can I differentiate filter plugging due to air bubbles, particulates, surface tension, inappropriate filter size, etc.?||Air locking will occur when filtration is initiated without adequate venting or when air bubbles become trapped in fluid lines. Air will pass easily through a dry hydrophillic or hydrophobic filter. However, when a filter is wet and air is applied to a surface, the air will remain until it is manually moved upstream by venting or until the bubble point of the filter is reached. Bubble point is defined as the pressure at which gas displaces liquid for the largest set of filter pores and is able to flow through the pores. Air locking reduces the effective filtration area of the filter and thus reduces the flow rate.
Surface tension refers to the strong cohesive forces present between molecules at the surface of a liquid. The higher the surface tension, the more force is required to force fluid through the membrane..
Innapropriate filter size will can cause a filter to plug prematurely. Filter pore size is chosen based on the application. If the application requires a sterile fluid, than a 0.22 micron membrane would be used for standard solutions that have bacterial bioburden. A 0.1 micron filter would be used for applications where mycoplasma is a concern. Where virus contamination is a concern, ultrafiltration would be required. The selection of a filter pore size that is smaller than that required for the application will cause a decrease in filter capacity and an increase in cost.
|Why are there no diffusion specifications on my Millipak/Millidisk/4" Opticap?||Diffusion testing is proportional to the overall effective filtration areas. On small area devices (less than 2000 cm2) the diffusion flow rate is relatively small. This small flow rate will be difficult to accurately measure and therefore only a bubble point specifications is provided.|
|Hydrophilic Durapore® Cartridges and Capsules User Guide|
|Wetting Instructions for Filter Units with Durapore Membrane|
Hydrophobic Durapore® 0.22 µm Cartridge FiltersReliable filters for the sterile filtration of gases and liquids
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OptiScale® Capsule Filters for Aseptic Processing ApplicationsOptiScale<sup>®</sup> capsules, with a large variety of filtration media options, are a family of convenient, disposable filters ideal for media selection, process screening and scaling.
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Hydrophobic Durapore® 0.22 µm Capsule FiltersReliable filters for the sterile filtration of gases and liquids. Eliminate the time and expense associated with assembling, cleaning, and validating stainless steel housings.
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Durapore® 0.1 µm and 0.22 µm Capsule FiltersSterilizing-grade 0.1 µm and 0.22 µm hydrophilic polyvinylidene fluoride (PVDF) membranes are low protein binding and provide sterility assurance, high flow rates and throughputs.
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Durapore® 0.45 µm Cartridge FiltersThe superior solution for extending the life of downstream sterilizing filters by removing colloidal and particulate contaminants
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Durapore® 0.1 µm and 0.22 µm Cartridge FiltersA trusted name in the industry for over 25 years, The Durapore membrane contributes to clean processes due to low extractables, broad chemical compatibility, and its non-fiber releasing properties.
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Durapore® 0.45 µm Capsule FiltersAutoclavable, Gamma compatible or Presterilized bioburden reduction filters for process protection and prefiltration in single use applications
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Related Products By: Application Facete
|Dialysis and Filtration|
Related Products By: Brand Facete
|Biopharmaceutical Manufacturing > Upstream Processing > Bioburden Reduction / Particulate Control > Membrane based > Durapore|
Millidisk® cartridge filters are stacked disc filters designed for the removal of particles and microorganisms from liquids and gases. The stacked disc design allows minimal hold-up volume and particle shedding, making Millidisk® filters ideally suited for high-value added applications. All Millidisk® filters are made with Durapore® PVDF membranes, providing high flow rates and throughputs, low extractables, broad chemical compatibility and the lowest protein binding of any membrane available.
Millidisk® filters are available in 0.1 µm, 0.22 µm (hydrophilic and hydrophobic), 0.45 µm and 5.0 µm pore sizes. Four available cartridge sizes allow optimum flexibility for easy scale up and system sizing. Millidisk® filters are designed to be used with either Millidisk® or Millidisk®/Milligard® housings.
For traceability and easy identification, each Millidisk® filter is labelled with its catalogue number, lot number and serial number. Each unit is 100% integrity tested during manufacturing.
- Sterile filtration of parenterals, diagnostics and buffers
- Sterile filtration of media and biologicals
- Particle removal (clarification) of high value-added pharmaceuticals
- Sterile filtration of non-aqueous liquids and gases with the hydrophobic units
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.
|Materials of Construction|
|Filter||Polyvinylidene Fluoride (PVDF)|
|or||Polyvinylidene Fluoride (PVDF)|
|Support Discs and Adapter||Polysulfone|
|Filtration Area, cm2|
|Millidisk® 10||500 cm²|
|Millidisk® 20||1000 cm²|
|Millidisk® 40||2000 cm²|
|Maximum Differential Pressure, bar (psid)|
|Forward: 4.1 bar (60 psid) @ 25 °C; 1.7 bar (25 psid) @ 80 °C; 0.35 bar (5 psid) @ 123 °C; Reverse: 0.7 bar (10 psid) @ 25 °C|
|Bacterial Retention (for Millidisk 0.1 µm and 0.22 µm only)|
|Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.|
|Aqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test|
|Millidisk® 10||≤2.5 mg/unit|
|Millidisk® 20||≤5.0 mg/unit|
|Millidisk® 30||≤7.5 mg/unit|
|Millidisk® 40||≤10.0 mg/unit|
|Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥200 mL|
|Component materials meet the requirements of the USP Class VI Biological Test for Plastics. Millidisk units also meet the requirements of the USP General (Mouse) Safety Test.|
|5 SIP cycles of 60 min @ 135 °C; 5 autoclave cycles of 60 min @ 126 °C|
|Integrity Test, Bubble Point|
|0.1 µm units||≥4830 mbar (70 psig) air with water|
|0.22 µm units||≥3450 mbar (50 psig) air with water|
|0.45 µm units||≥1790 mbar (26 psig) air with water|
|5 µm units||≥138 mbar (2 psig) air with water|
|0.22 µm hydrophobic units||≥1170 mbar (17.0 psig) nitrogen with 100% IPA|