Planova™ 15N, 20N and 35N Virus Removal Filters
The Pioneering Virus Removal Filter
with Proven Reliability Since 1989
Developed specifically to remove viruses from biopharmaceutical products, Planova™ filters have been setting the standard in virus filtration since their launch in 1989. Featuring regenerated cellulose hollow fiber membranes, the Planova™ 15N, 20N, and 35N filters are highly regarded for their consistent performance and quality over more than 30 years, contributing to the virus safety of biologics worldwide.
- High Performance Filtration Enabled by Unique Hollow Fiber Structure
- Stable Filtration, Less Impacted by pH and Conductivity
- Robust Virus Removal
- Exellent Scalability and Lot-to-Lot Consistency
Virus Removal Filters - Planova™ Lineup
Features
High Performance Filtration Enabled by Unique Hollow Fiber Structure
Planova filters remove viruses through a size exclusion mechanism. With their unique hollow fiber structure, protein solutions pass through the membrane without adsorption or denaturation, while viruses are efficiently captured in the membrane pores.
High Product Recovery
The inherent hydrophilicity of the cellulose membrane allows for excellent protein permeability. For example, the Planova 20N filter demonstrates high recovery rates for plasma-derived immunoglobulin (IgG) and proteins with a molecular weight of up to 340 kDa, such as Factor VIII.
Planova filters deliver high filtration performance across a wide range of formulations, minimizing the need for complex optimization. This enables a shortened development timeline and efficient process development.
Planova filters deliver high filtration performance across a wide range of formulations, minimizing the need for complex optimization. This enables a shortened development timeline and efficient process development.
Product recovery and virus removal data for Planova 15N, 20N and 35N are shown in the following tables. These data show efficient performance for a variety of formulations and filtration conditions.
| Product Recovery Rates | |||
|---|---|---|---|
| Polyclonal IgG (30 mg/mL) |
Monoclonal IgG (20 mg/mL) |
Factor VIII (100 IU/mL) |
|
| Planova 15N | <90% | >95% | 20-80% |
| Planova 20N | >95% | >98% | 20-80% |
| Planova 35N | 100% | 100% | >95% |
Stable Filtration, Less Impacted by pH and Conductivity
Stable Filtration Performance for Factor VIII at Various Concentrations
For filtration performance evaluated with different concentrations of Factor VIII, Planova 20N filters consistently demonstrate stable filtration.
Adapted from: F. Mori, Kedrion;
Planova Workshop 2017
Planova Workshop 2017
Consistent Filtration Performance Under Various pH Conditions
For multiple mAbs under various pH conditions, Planova 20N filters showed consistent and stable flux, demonstrating robustness across a wide range of solution conditions.
Adapted from: Josh Goldstein, Janssen,
2014 Planova Workshop
2014 Planova Workshop
Robust Virus Removal
Consistent Virus Removal Performance Under Various Conditions
Planova filters deliver robust virus removal performance regardless of changes in key parameters such as protein load, concentration, pH and ionic strength.
In tests using various concentrations of IgG solutions spiked with PPV, Planova 20N consistently achieved PPV LRV (logarithmic reduction value) of 4.0 or greater, demonstrating stable removal efficiency regardless of throughput.
In tests using various concentrations of IgG solutions spiked with PPV, Planova 20N consistently achieved PPV LRV (logarithmic reduction value) of 4.0 or greater, demonstrating stable removal efficiency regardless of throughput.
Adapted from: T. Hongo-Hirasaki et al.,
J. Membr. Sci., 278 (2006)
J. Membr. Sci., 278 (2006)
Planova 20N filters demonstrate high PPV LRV for various NaCl concentrations and pH conditions.
| NaCl conc. (mM) | PPV LRV | Filtration time (h) | Filtration vol. (L/m2) | Throughput (kg/m2) |
|---|---|---|---|---|
| 1 | ≥5.84 | 6.0 | 152 | 1.52 |
| 10 | ≥6.34 | 6.0 | 200 | 2.00 |
| 100 | ≥6.00 | 6.0 | 240 | 2.40 |
| 200 | ≥5.67 | 6.0 | 220 | 2.20 |
| 500 | ≥6.00 | 6.0 | 190 | 1.90 |
Filtration conditions: 10 mg/mL IgG, pH 4.5 | Serum-free PPV 0.5 vol% | Pressure: 78.4 kPa
Adapted from: T. Hongo-Hirasaki, presented at the PDA Europe Workshop on Virus Removal by Filtration, 2011
| pH | PPV LRV | Filtration time (h) | Filtration vol. (L/m2) | Throughput (kg/m2) |
|---|---|---|---|---|
| 4.5 | ≥6.00 | 6.0 | 152 | 1.52 |
| 5 | ≥6.00 | 6.0 | 200 | 2.00 |
| 6 | ≥6.00 | 6.0 | 240 | 2.40 |
| 7 | ≥5.78 | 6.0 | 220 | 2.20 |
| 8 | ≥6.09 | 6.0 | 190 | 1.90 |
Filtration conditions: 10 mg/mL IgG, 100 mM NaCl | Serum-free PPV 0.5 vol% | Pressure: 78.4 kPa
Adapted from: T. Hongo-Hirasaki, presented at the PDA Europe Workshop on Virus Removal by Filtration, 2011
Excellent Scalability and Lot-to-Lot Consistency
The stable performance and consistent quality of Planova filters, unaffected by membrane area or production lot, support smooth process scale-up and trouble-free drug manufacturing operations.
Planova filters deliver consistent flux across effective membrane area and production lots.
Planova filters deliver consistent flux across effective membrane area and production lots.
Internal data
Documents
Technical Documents
Access technical documents for Planova 15N, 20N and 35N filters through the links below.
Related Presentations
Access presentations on Planova 15N, 20N and 35N filters through the links below.
Related Publications
Access publications on Planova 15N, 20N and 35N filters through the links below.
- Serial virus filtration: A case study evaluating the product-dependent impact of control strategies on process efficiency
- Effect of pH, NaCl concentration, and mAb concentration of feed solution on the filterability of Planova™ 20N and Planova™ BioEX
- Size-based analysis of virus removal filter fouling using fractionated protein aggregates
Brochures
Product Specifications
| Planova 15N, 20N and 35Na | ||||||||
|---|---|---|---|---|---|---|---|---|
| Effective surface area (m²) | 4.0 | 1.0 | 0.3 | 0.12 | 0.01 | 0.001 | ||
| Component | Hollow fiber membrane | Cuprammonium regenerated cellulose | ||||||
| Housing and headers | Polycarbonate | |||||||
| Sealant | Polyurethane | |||||||
| O-rings | Silicone | |||||||
| Nozzle plugs | Silicone | - | ||||||
| Nozzle caps | - | Silicone | ||||||
| Ferrule caps | Polycarbonate | - | ||||||
| Balloon cap holders | Polycarbonate | - | ||||||
| Gaskets | Silicone | - | ||||||
| Balloon caps | Silicone | - | ||||||
| Nozzle stoppers | - | Silicone | - | |||||
| Clamp bands | Polysulfone | - | ||||||
| Threaded clamps | Clamp bolts | - | Polypropylene | - | ||||
| Clamp nuts | - | Polypropylene | - | |||||
| Pin bands | - | SUS304 | - | |||||
| Supplied as | Filled with purified waterb | |||||||
| Sterilization method | Autoclaving | |||||||
| Packaging format | Packed individually in sterilization bags | |||||||
| Operating pressure (TMP) | ≤98 kPa | |||||||
| Operating pH | 3-9 | |||||||
a Planova 35N filters can be used as effective prefilters prior to final virus filtration with Planova 15N or 20N filters.
b Purified water in 4.0 m² filters contains NaCl (≤0.1%).
b Purified water in 4.0 m² filters contains NaCl (≤0.1%).
Integrity Testing
Integrity testing of Planova 15N, 20N and 35N filters is performed to confirm the integrity of the filters used during filtration.
Two types of integrity tests are required. The leakage test is conducted pre-use and post-use to detect gross defects, and the post-use gold particle test (GPT) is conducted to confirm the absence of pore size shift during filtration.
Two types of integrity tests are required. The leakage test is conducted pre-use and post-use to detect gross defects, and the post-use gold particle test (GPT) is conducted to confirm the absence of pore size shift during filtration.
Gold Particle Test (GPT)
The gold particle test (GPT) is conducted by filtering diluted integrity test solution through the post-use filter and comparing the calculated Asahi gold particle (AGP) logarithmic reduction value to the standard AGP LRV.
The diluted integrity test solution is prepared from an Asahi Integrity Test Solution Kit matched to Planova filter type. A passing result indicates the absence of pore size distribution shift during product filtration.
Automation of the GPT is possible with the Gold Particle Test System (VANTIJ-GPTS). This system enables easy and rapid integrity testing of Planova™ filters, improving operational efficiency.
The diluted integrity test solution is prepared from an Asahi Integrity Test Solution Kit matched to Planova filter type. A passing result indicates the absence of pore size distribution shift during product filtration.
Automation of the GPT is possible with the Gold Particle Test System (VANTIJ-GPTS). This system enables easy and rapid integrity testing of Planova™ filters, improving operational efficiency.
Leakage Test
The leakage test is conducted pre-use and post-use to confirm that the filter is free from gross defects such as pinholes and other membrane damage. Only filters that pass the pre-use test may be used for product filtration. For Planova 15N, 20N and 35N filters, the post-use filter must pass both the GPT and VLT to be judged as "passing".
The visual leakage test is conducted by pressurizing the hollow fibers and observing the filter for continous bubbling. The leakage test of filters with effective surface area of 0.12 m2 or larger can be conducted by automated methods using the PlanovaTM Leak Tester.
The visual leakage test is conducted by pressurizing the hollow fibers and observing the filter for continous bubbling. The leakage test of filters with effective surface area of 0.12 m2 or larger can be conducted by automated methods using the PlanovaTM Leak Tester.
Visual Leakage Test
Related Products & Services
Related Products
Services
Ordering Information
Please reference the catalog number when placing orders.
| Filter type | Effective surface area (m²) | Catalog number |
|---|---|---|
| Planova 15N | 4.0 | 15N4-000 |
| 1.0 | 15F1-000 | |
| 0.3 | 15NZ-300 | |
| 0.12 | 15NZ-120 | |
| 0.01 | 15NZ-010 | |
| 0.001 | 15NZ-001 | |
| Planova 20N | 4.0 | 20N4-000 |
| 1.0 | 20F1-000 | |
| 0.3 | 20NZ-300 | |
| 0.12 | 20NZ-120 | |
| 0.01 | 20NZ-010 | |
| 0.001 | 20NZ-001 | |
| Planova 35N | 4.0 | 35N4-000 |
| 1.0 | 35F1-000 | |
| 0.3 | 35NZ-300 | |
| 0.12 | 35NZ-120 | |
| 0.01 | 35NZ-010 | |
| 0.001 | 35NZ-001 | |
| Planova 75N (prefilter) | 1.0 | 75F1-000 |
| 0.3 | 75NZ-300 | |
| 0.01 | 75NZ-010 | |
| 0.001 | 75NZ-001 |
