Sterile filtration is the process of completely removing all microorganisms from a fluid stream without adversely affecting product quality. In the manufacturing of sterile products, sterilizing-grade filtration is a crucial step that ensures the safety and efficacy of various products ranging from drugs to beverages. This technology relies on complex filters with precise pore size, which must be rigorously tested to meet strict regulatory standards. Sterilizing-grade filters can be classified based on their membrane materials and forms. Syringe, capsule, and cartridge are main filter forms. The membrane materials for sterilizing-grade filtration include polyethersulfone (PES), polyvinylidene fluoride (PVDF), polytetrafluoroethylene (PTFE), and nylon.
PES is a commonly used membrane material due to its high flow rate, low protein binding properties, and wide chemical compatibility. PES filters can be used for filtering aqueous solutions, buffers, and biological products. PVDF is a polymer with extremely low protein binding rate and excellent chemical compatibility, and is suitable for high-demand applications involving precious proteins and antibodies. Amerigo Scientific offers three generations of SaiPress® PES hydrophilic filters and SaiPress® PVDF hydrophilic filters to meet various sterilization filtration requirements.
| SaiPress® PES Sterilizing-grade Hydrophilic Filters Suitable for pre-filtration, etc. |
SaiPress® HF Sterilizing-grade Hydrophilic Filters High flux. Suitable for the filtration of buffer solutions and intermediate products |
| SaiPress® HF Pro Sterilizing-grade Hydrophilic Filters High flux, high capacity, and high standard. Suitable for chemical synthetic media filtration and final filtration |
SaiPress® PVDF Sterilizing-grade Hydrophilic Filters Suitable for sterile filtration of various biopharmaceutical products |
| TOC and conductivity | The detected TOC value is ≤0.5mg/L, and the electrical conductivity value is ≤1.3us/cm. |
| Cleanliness | Meeting the "no fiber release" filter standard as defined in 21 FR210.3 (b) (6) |
| Bacterial endotoxin | The endotoxin content of the filter solution was determined, and the content of endotoxin in the filter solution was lower than 0.25EU/ml. |
| Bacterial retention | The bacterial retention rate of the products was tested using the test method of ASTMF838 and with the defective Pseudomonas (ATCC19146). The results showed that the minimum retention rate was 10⁷cfu/cm². |
| Regulatory compliance | Product production and quality management in accordance with ISO:9001 (2015) |
| Shelf life | 3 years |
| Storage and transportation | This product should be stored in an environment of 0 to 30°C, avoiding freezing and high temperature (>40°C) conditions. The internal bag should be kept intact to prevent external particles or moisture from entering. |
Amerigo Scientific offers SaiPress® sterilizing-grade hydrophilic filters, which are made of polyether sulfone (PES) as the membrane material and possess excellent chemical compatibility. Filters in different specifications are available for process reduction and scale-up.
| Product | Nominal Size |
|---|---|
| SaiPress® Sterilizing-grade Hydrophilic Capsule Filter | 1 inch; 2.5 inch; 5 inch; 10 inch; 20 inch; 30 inch |
| SaiPress® Sterilizing-grade Hydrophilic Cartridge Filter | 2.5 inch; 5 inch; 10 inch; 20 inch; 30 inch |
| SaiPress® Sterilizing-grade Hydrophilic Disk Filter | Φ50mm |
| Filter type | Disk Filter | Capsule Filter | Cartridge Filter | ||||||||||
| Nominal size (inch) | Φ50mm | 1 | 2.5 | 5 | 10 | 20 | 30 | 2.5 | 5 | 10 | 20 | 30 | |
| Effective filtration area (m²) | Single layer | 13.8cm² | 380cm² | 0.16 | 0.33 | 0.66 | 1.32 | 1.98 | 0.16 | 0.33 | 0.66 | 1.32 | 1.98 |
| Double layer | 13.8cm² | 350cm² | 0.14 | 0.28 | 0.57 | 1.14 | 1.71 | 0.14 | 0.28 | 0.57 | 1.14 | 1.71 | |
| Filter membrane pore size | 0.1μm/0.22μm/0.45μm/0.65μm/0.8μm/1.2μm/0.22+0.1μm/0.45+0.1μm/0.45+0.22μm/0.65+ 0.22μm/0.8+0.22μm/1.2+0.22μm/0.8+0.45μm/1.2+0.45μm |
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| Material | Filter membrane | Hydrophilic polyether sulfone (PES) | |||||||||||
| Supporting layer/Housing/ structural components | Polypropylene (PP) | ||||||||||||
| Vent O-ring | -- | Silicone | -- | ||||||||||
| O-ring | -- | -- | Silicone/EPDM/FKM | ||||||||||
| Maximum operating pressure difference | -- | Forward: 5.5bar (80psi) at 25°C; 1.7bar (25psi) at 80°C Reverse: 2.1ba r(30psi) at 25°C |
Forward: 5.5bar (80psi) at 25°C; 1.7bar (25psi) at 80°C Reverse: 2.1bar (30psi) at 25°C |
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| Bubble point (100% IPA at 25°C) | 0.1μm:≥2500mbar | ||||||||||||
| Bubble point (pure water at 25°C) | 0.22μm: ≥3400mbar 0.45μm: ≥2000mbar 0.65μm: ≥1500mbar | ||||||||||||
| 0.1μm filter diffusion flow (ml/min) (Pure water at 25°C, 2800mbar) | -- | ||||||||||||
| ≤2.5 | ≤ 7.5 |
≤ 15 |
≤ 30 |
≤ 60 |
≤ 90 |
≤ 7.5 |
≤ 15 |
≤ 30 |
≤ 60 |
≤ 90 |
|||
| 0.22μm filter diffusion flow (ml/min) (Pure water at 25°C, 2800mbar) | -- | ||||||||||||
| ≤2.5 | ≤ 7.5 |
≤ 15 |
≤ 30 |
≤ 60 |
≤ 90 |
≤ 7.5 |
≤ 15 |
≤ 30 |
≤ 60 |
≤ 90 |
|||
| Sterilization method | Gamma not applicable | SIP not applicable | Gamma not applicable | ||||||||||
| Offline: 126°C/60 minutes, 5 times | Code R: Tolerance 40KGy gamma irradiation, autoclave not allowed Code A: Offline: 126°C/60min, 3 times, Gamma irradiation not allowed |
Offline :126°C / 60min, 25 times SIP :126°C / 60min, 25 times (In the sterilization process, the upstream and downstream pressure difference of the cartridge is ≤300mbar) |
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| Pressure test | -- | No leakage detected under 0.65MPa pressure | -- | ||||||||||
| Biosafety testing | All materials of the filter cartridge meet USP <88>, in vivo biosafety evaluation of Class VI plastic products and in vitro biosafety test of USP <87> | ||||||||||||
SaiPress® HF filters are high-flux sterilizing-grade hydrophilic PES filters. There are various specifications of capsule-type, cartridge-type and disk-type filters available for selection.
| Product | Nominal Size |
|---|---|
| SaiPress® HF Sterilizing-grade Hydrophilic Capsule Filter, 2.5/5 inch Size | 2.5 inch; 5 inch |
| SaiPress® HF Sterilizing-grade Hydrophilic Capsule Filter, 10 inch Size | 10 inch |
| SaiPress® HF Sterilizing-grade Hydrophilic Capsule Filter, 20/30 inch Size | 20 inch; 30 inch |
| SaiPress® HF Sterilizing-grade Hydrophilic Cartridge Filter | 2.5 inch; 5 inch; 10 inch; 20 inch; 30 inch |
| SaiPress® HF Sterilizing-grade Hydrophilic Disk Filter | -- |
| Filter type | Disk Filter | Capsule Filter | Cartridge Filter | ||||||||||
| Nominal size (inch) | -- | 1 | 2.5 | 5 | 10 | 20 | 30 | 2.5 | 5 | 10 | 20 | 30 | |
| Effective filtration area (m²) | Single layer | 2.8cm² | 380cm² | 0.16 | 0.33 | 0.65 | 1.3 | 1.95 | 0.16 | 0.33 | 0.65 | 1.3 | 1.95 |
| Double layer | 2.8cm² | 350cm² | 0.14 | 0.28 | 0.55 | 1.1 | 1.65 | 0.14 | 0.28 | 0.55 | 1.1 | 1.65 | |
| Filter membrane pore size | 0.22μm/0.45μm/0.45+0.22μm | ||||||||||||
| Filter element / Structure / Material |
Filter membrane | Hydrophilic polyether sulfone (PES) | |||||||||||
| Supporting layer | Polypropylene (PP) | ||||||||||||
| Housing/structural components | Polypropylene (PP) | ||||||||||||
| Vent O-ring | -- | Silicone | -- | ||||||||||
| O-ring | -- | -- | Silicone/EPDM/FKM | ||||||||||
| Maximum operating pressure difference | -- | Forward: 5.5bar (80psi) at 25°C; 1.7bar (25psi) at 80°C Reverse: 2.1bar (30psi) at 25°C |
Forward: 5.5bar (80psi) at 25°C; 1.7bar (25psi) at 80°C Reverse: 2.1bar (30psi) at 25°C |
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| Bubble point(100% IPA at 25°C) | 0.22μm: ≥3400mbar 0.45μm: ≥ 2000mbar | ||||||||||||
| 0.22um filter diffusion flow (ml/min) (Pure water at 25°C, 2800mbar) |
-- | ≤2.5 | ≤7.5 | ≤15 | ≤30 | ≤60 | ≤90 | ≤7.5 | ≤15 | ≤30 | ≤60 | ≤90 | |
| Sterilization method | -- | SIP not applicable | Gamma not applicable | ||||||||||
| Code R: Tolerance 40KGy gamma irradiation, autoclave not allowed; Code A: Offline: 126°C/60min, 3 times, Gamma irradiation not allowed |
Offline :126°C / 60min, 25 times SIP :126°C / 60min, 25 times (In the sterilization process, the upstream and downstream pressure difference of the cartridge is ≤300mbar) |
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| Pressure test | -- | No leakage detected under 0.65MPa within 24h | -- | ||||||||||
| Biosafety testing | All materials of the filter cartridge meet the biosafety assessment of USP <88>, Class VI -70°C grade plastic materials | ||||||||||||
| Insoluble particles | Unless otherwise specified, the number of particles containing 10μm and more than 10μm in each 1ml filter rinse solution shall not exceed 25 particles, and the number of particles containing 25μm and more than 25μm shall not exceed 3 particles | ||||||||||||
SaiPress® HF Pro is an ultra-high flux sterilizing-grade PES filter, suitable for chemical synthetic media filtration and final sterilization filtration.
| Filter type | Syringe Filter | Capsule Filter | Cartridge Filter | |||||||||
| Nominal size (inch) | -- | 1 | 2.5 | 5 | 10 | 20 | 30 | 2.5 | 5 | 10 | 20 | |
| Effective filtration area (m²) | Double layer | 2.8cm² | 350cm² | 0.14 | 0.28 | 0.57 | 1.14 | 1.71 | 0.14 | 0.28 | 0.57 | 1.14 |
| Filter membrane pore size | 0.22+0.1μm/0.45+0.22μm | |||||||||||
| Material | Filter membrane | Hydrophilic polysthersulfone (PES) | ||||||||||
| Supporting layer | Polypropylene (PP) | |||||||||||
| Housing/structural components | Polypropylene (PP) | |||||||||||
| Vent O-ring | -- | Silicone | -- | |||||||||
| O-ring | -- | -- | Silicone / EPDM / FKM | |||||||||
| Maximum operating pressure difference | -- | Forward: 5.5bar (80psi) at 25°C; 1.7bar (25psi) at 80°C Reverse: 2.1bar (30psi) at 25°C |
Forward: 5.5bar (80psi) at 25°C; 1.7bar (25psi) at 80°C Reverse: 2.1bar (30psi) at 25°C |
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| Bubble point（100% IPA at 25°C） | ≥2500mbar (100%IPA@25°C) | |||||||||||
| 0.1μm filter diffusion flow (ml/min) (Pure water at 25°C, 2800mbar) | -- | ≤2.5 | ≤7.5 | ≤15 | ≤30 | ≤60 | ≤90 | ≤7.5 | ≤15 | ≤30 | ≤60 | |
| Sterilization method | -- | SIP not applicable | Gamma not applicable | |||||||||
| Code R: Tolerance 40KGy gamma irradiation, autoclave not allowed; Code A: Off-line: 126°C/60min, 3 times, Gamma not allowed |
Offline :135°C* 30min, 25 times SIP :135°C* 30min, 25 times (In the sterilization process, the upstream and downstream pressure difference of cartridge is ≤300mbar) |
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| Pressure test | -- | No leakage detected under 0.65MPa within 24h | -- | |||||||||
| Biosafety testing | All materials of the filter cartridge meet the biosafety assessment of USP <87> , USP <88>, Class VI -70°C plastic materials | |||||||||||
| Insoluble particles | Unless otherwise specified, the number of particles containing 10μm and more than 10μm in each 1ml filter rinse solution shall not exceed 25 particles, and the number of particles containing 25μm and more than 25μm shall not exceed 3 particles | |||||||||||
SaiPress® PVDF sterilizing-grade hydrophilic filters are suitable for the sterile filtration of various biopharmaceutical products. The filter membrane is made of PVDF and has a symmetric pore structure. Therefore, SaiPress® PVDF sterilizing-grade hydrophilic filters possess the advantages of uniform hydrophilicity, high porosity, and extremely low protein adsorption rate.
| Product | Nominal Size |
|---|---|
| SaiPress® PVDF Sterilizing-grade Hydrophilic Cartridge Filter | 5 inch; 10 inch; 20 inch; 30 inch |
| SaiPress® PVDF Sterilizing-grade Hydrophilic Disk Filter | 2.8m² |
| Welding method | Sealed by heat welding (no adhesives) | |
| Material Structure | Filter membrane | PVDF |
| Supporting layer | Polypropylene | |
| Housing | Polypropylene | |
| Central core | Polypropylene | |
| Connector | Polypropylene | |
| O-ring | Silicone/EPDM/FKM | |
| Size | Outer Diameter | 69 mm |
| Inner Diameter | 33 mm | |
| Length | 5 - 40 inch | |
| Effective filtration area (m²) | Single layer: 0.65m²/10inch; Double layer: 0.55m²/10inch | |
| Maximum operating pressure difference | Forward | 5.2 bar at 25°C, 2.7 bar at 80°C |
| Reverse | 2.1 bar at 25°C | |
| Biosafety testing | Bacterial endotoxin | ＜0.25 EU/mL |
| Sterilization method |
SIP | 124°C, 30min, 30 times; 134°C, 20min, 30 times |
| Autoclave | 124°C, 30min, 30 times; 134°C, 20min, 30 times | |
| Quality Control | ISO 9001: 2015 Quality Management System; 100% integrity testing; Full traceability of filters; All materials meeting CFR 21 requirements; Validated bacterial retention efficiency |
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Filgiant® sterilizing-grade hydrophobic filters are composed of single-layer or double-layer polytetrafluoroethylene (PTFE) membranes and polypropylene components. Due to the excellent chemical compatibility, high flow rate, high flux, and no fiber shedding of the filters, they can meet high requirements of gas filtration.
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