PURAFIX® Modules
Modules for DEPTH Filtration
«Low Ion» or «Low Ion and Low Pyrogen» for pharmaceutical and other high purity applications
Characteristics
Depth filter modules allow the user to handle large filter areas easily in a disposable assembly. Filtration is performed in a closed system. Depth filter sheets inside have a high particle load capacity of up to 4 kg per m2. In the filtration process, dirt particles are slowed down and eventually retained by the tortuous path inside the filter sheet and by electrokinetical interactions («zeta potential»). Through this unique mechanism, a high capacity (long lifetime of filter until plugging) can be achieved. All materials are FDA approved.
Dimensions
Modules are available in the following versions:
| 12“ | 16“ | |
|---|---|---|
| Diameter [mm] | 300 | 400 |
| Filter area/module [m2] | 1.8 | 3.6 |
| Height (bayonet adapter) [mm] | 330 | 330 |
| Height (flat adapter) [mm] | 272 | 272 |
Filter area for modules with 16 cells. Modules with reduced number of cells are available upon request.
Adapter Types
The FILTROX depth filter modules are available in all common adapter types:
- flat adapter (= DOE)
- bayonet adapter (= DOR = F)
Historically, the flat adapter is quite common. The bayonet adapter is a safer alternative and for sterile filtration the adapter of choice due to its double-o-ring sealing gaskets. The handling of that adapter type is, in addition, much easier.
Rigid Construction
The module consists of a polypropylene backbone (rigid core) and depth filter sheets on drainage bodies.
Working Principle
The module is placed in a special housing. Turbid liquid fills the space between the housing and the outside part of the module. The liquid flows through the sheets where dirt particles are retained. The clear liquid is drained through the inside of the drainage body and the rigid core to the outlet of the filter housing.
Applications
The filtration work is done by the depth filter sheets, which are available in a variety of porosities, from coarse, fine to germ reducing and -removing filtration («sterile filtration»). PURAFIX® modules are recommended for applications with high demands on purity (low concentration of extractable ions).
PURAFIX® «P» (=low pyrogen) modules are recommended, when in addition, a low concentration of extractable pyrogens is required.
Application examples
- Pharmaceutical active ingredients
- Vaccines
- Injectables (absolute membrane as police filter required)
Retention rates of coarse and fine filtration sheets
The following nominal porosities (retention rates) are available:
| Type module | Retentation rate [μm] |
Flowrate [l/m2 min] Dp=1 bar |
|
|---|---|---|---|
| CH 03 (P) | 20 | 2800 – 3600 | Coarse Filtration |
| CH 09 (P) | 10 | 1500 – 2100 | Coarse Filtration |
| CH 23 (P) | 6.0 | 560 – 700 | Clarifying Filtration |
| CH 33 (P) | 5.0 | 280 – 360 | Clarifying Filtration |
| CH 43 (P) | 4.0 | 240 – 300 | Clarifying Filtration |
| CH 73 (P) | 1.5 | 170 – 210 | Fine Filtration |
| CH 103 P | 0.6 | 100 – 120 | Germ Reducing Filtration |
| CH 113 P | 0.5 | 68 – 80 | Sterile Filtration |
| CH 133 P | 0.4 | 45 – 56 | Sterile Filtration |
| CH 143 P | 0.2 | 26 – 34 | Sterile Filtration |
| CH 153 P | 0.04 | 10 – 16 | Sterile Filtration |
please find a converter to Gallons/sqft here:
Pore size in depth filter sheets is measured indirectly by the flow rate. The correlation between pore size and flow rate is empirical. Nominal pore sizes in this list are only values for orientation. The real retention rate is depending on the nature of the dirt particles, solvent and other factors and must be tested as a part of the method development.
Operating Conditions
- Max. operating temperature: 82° C
- Max. differential pressure (module): 2.4 bar
- Recommended rinsing volume: 50 l/m2
- Recommended sterilization: hot water or chemical
Note: For chemical sterilization with oxidizing agents do not exceed recommended contact time. Inline steam sterilization requires careful handling to avoid back pressure.
Logarithmic bacteria retention value (LRV)
| Type | Test germ | Load | LRV |
|---|---|---|---|
| CH 103 (P) | Reducing the number of germs | ||
| CH 113 (P) | Serratia marcescens | 1.0 X 107/cm2 | >6 |
| CH 133 (P) | Serratia marcescens | 1.0 X 108/cm2 | >7 |
| CH 143 (P) | Serratia marcescens | 1.0 X 109/cm2 | >8 |
| CH 153 (P) | Brevundimonas diminuta | 1.0 x 109/cm2 | >8 |
Test germs: Serratia marcescens, ATCC 14756
Brevundimonas diminuta, ATCC 19146
Pyrogen release (for Purafix® «P» series only)
Due to a special manufacturing process the PURAFIX® P series has a reduced specified endotoxin release < 0.125 EU/ml.
FILTROX Quality Assurance
FILTROX assures the best quality control according to international standards:
- ISO 9001 (Quality management)
- ISO 14001 (Environmental management)
- FDA drug master file: #16418
External tests of lenticular modules and filter sheets were performed and certified according to
- USP plastic class test VI (BSL, Munich)
- other CFR requirements by the NAmSA
FILTROX is using polyamidoamine as a wet strength agent in its filter sheets. The ISEGA Institute in Aschaffenburg (Germany) performed a test for extractable MCPD and DCP. The Filtrox filter sheets extracts were below the detection limit of the approved standard method for DCP and MCPD. The filter sheets are free of GMO and common allergens. The backbone material of the lenticular modules is polypropylene.
Extractables
Due to the special production conditions the PuraFix® depth filter sheets have an extremely low release of extractables.
| Ion/ | ppm | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Ca | Mg | Pb | Zn | Cd | Cu | Ni | Co | Fe | Al |
| < 1 | < 0.1 | < 0.001 | < 0.010 | < 0.001 | < 0.001 | < 0.002 | < 0.0015 | < 0.03 | < 0.05 |
Gasket Material
Available material:
- Silicone (standard)
- EPDM
- Teflon® (encapsuled gaskets)
Material (Filter Sheets)
Purified and bleached cellulose, natural inorganic filter aid and polyamidoamine (< 3%).
Diatomaceous Earth
Sheets with an ash content > 1 contain diatomaceous earth (DE/ «Kieselguhr») or perlite as an inorganic filter aid. FILTROX uses only natural kieselguhr with a cristobalite content < 1 % (detection limit).
pdf Download of Technical Info Sheet
Please download the technical info sheet from here.