Filter cartridges
Filter cartridges, capsules and filter housings from Sefar
We supply SEFAR® PHARMA GMP Cartridges, Sefar filter cartridges for liquid and gas filtration in pharmaceuticals, bioprocessing, food and fine chemicals. The range covers 250 µm down to 0.03 µm absolute, with filter media in PES, ePTFE, PP, nylon, glass fibre and stainless steel.
- Pore ratings in the range, absolute
- 0.03–250 µm
- Standard cartridge lengths
- 5–40"
- Sterilising PES membrane, SEFAR BioSef 3 Plus
- 0.2 µm
- GMP Class D cleanroom for PHARMA GMP
- ISO 8
The range at a glance
SEFAR PHARMA GMP Cartridges comprise disposable cartridges, encapsulated filters, metallic cartridges and stainless steel filter housings. Everything comes from one manufacturer, from coarse pre-filter to sterilising membrane.
Sefar makes the cartridges in several lengths and with many cores and end caps, so they fit existing equipment. Multi-layer media are available for pre-filtration and final filtration in a single step.
- Pleated depth filters in glass fibre and polypropylene for particle removal and pre-filtration
- Membrane cartridges in PES, nylon 6.6, ePTFE and PTFE for bioburden reduction, sterile filtration and sterile venting
- Junior cartridges for small volumes, pilot scale and batch processes
- SEFAR CapSef, ready-to-use capsules that need no filter housing
- SEFAR SinterSef, pleated metallic cartridges for high temperatures, cryogenic processes and demanding chemistry
- Stainless steel filter housings, sanitary and industrial
Cartridge families, filter media and pore ratings
The table shows the Sefar disposable cartridges in standard format with the pore ratings listed in the catalogue ordering tables. Typical applications are taken from the individual product sheets.
| Family | Filter medium | Pore rating | Typical applications |
|---|---|---|---|
| SEFAR MicroSef | Pleated borosilicate glass fibre with PP pre-filter layer | 0.5–5 µm absolute | Particle removal and pre-filtration ahead of membrane filters. Food, process water, pharmaceuticals, fine chemicals, cosmetics |
| SEFAR MicroSef WF | Glass fibre, pleated depth filter in wide format | 0.45–100 µm | Pre-filter or final polishing at very high flow rates, where membrane filtration is not required |
| SEFAR PolySef 2 | Meltblown PP in graded layers | 0.5–105 µm absolute | Pre-filtration ahead of membranes. Pharmaceuticals and bioprocessing, food, paints and coatings |
| SEFAR PolySef WF | PP, pleated depth filter in wide format | 0.45–100 µm | Pre-filter or final polishing at high flow rates. Complies with EC 1935/2004 for food contact |
| SEFAR TekSef A | Graded PP depth filter, also in nylon for solvents | 0.5–100 µm absolute | Food and beverages, fine chemicals and solvents, surface treatment, water ahead of reverse osmosis |
| SEFAR BioSef 2 | Hydrophilic PES membrane | 0.1–1.2 µm | Biopharmaceuticals, ophthalmics, fine chemicals, beverages, ultrapure water (18 MΩ·cm) |
| SEFAR BioSef 2 Plus | Dual-layer PES with integral pre-filter membrane | 0.2 and 0.45 µm | Biopharmaceuticals, fermentation, ophthalmics, API, LVP |
| SEFAR BioSef 3 | Single-layer PES, bioburden reduction with LRV ≥ 7 | 0.2 and 0.45 µm | Biopharmaceuticals, ophthalmics, beverages, pure water |
| SEFAR BioSef 3 Plus | Dual-layer PES, sterilising grade | 0.2 µm | Final sterile filtration, vaccines, parenterals (SVP, LVP), DI water and WFI |
| SEFAR FluoroSef | Hydrophobic ePTFE membrane | 0.2 and 0.45 µm | Sterile process gas and venting, solvents, photoresist and developer |
| SEFAR FluoroSef Plus | ePTFE with 316/316L stainless steel core | 0.2 µm | Sterile gas and venting, fermenter air, powder handling and tableting |
| SEFAR FluoroSef 100 | Hydrophobic PTFE membrane | 1 µm | Solvents and aggressive chemicals, removal of carbon particles |
| SEFAR VentaSef | ePTFE, with 1/4" or 1/2" BSP thread | 0.2 µm | Venting of autoclaves and sterile storage vessels |
| SEFAR HydroSef | Hydrophilic nylon 6.6 membrane | 0.1–0.45 µm | Bioburden reduction and clarification, pure water (18 MΩ·cm), semiconductors |
| SEFAR HydroSef Plus | Dual-layer nylon 6.6 | 0.1 and 0.2 µm | Biopharmaceuticals, fermentation, API and LVP, beverages |
The PES membranes have low protein binding. The nylon membranes in HydroSef bind more protein, according to Sefar.
Junior cartridges for small volumes
Junior cartridges fit existing junior-style filter housings and are used in small-scale pharmaceutical production, pilot studies and batch processes. They are 56 mm in diameter and come in lengths of 2.5" (77.5 mm) and 5" (136 mm). FluoroSef Junior is also available in 1.5" (43 mm).
The end style is chosen to suit the housing: J-style with internal O-ring, S-style with moulded flange seal and L-style with 4-lug locking end cap and double external O-rings. FluoroSef Junior is also available in N-style. J-style and L-style are steamed in place, S-style is autoclaved.
| Junior cartridge | Filter medium | Pore rating |
|---|---|---|
| SEFAR MicroSef Junior | Glass fibre with PP pre-filter | 0.5–5 µm absolute |
| SEFAR PolySef Junior | Meltblown PP | 0.5–1 µm absolute |
| SEFAR BioSef 2 Junior | PES membrane | 0.1–1.2 µm |
| SEFAR HydroSef Junior | Nylon 6.6 membrane | 0.1–0.45 µm |
| SEFAR FluoroSef Junior | ePTFE membrane | 0.2–0.65 µm |
Capsules: SEFAR CapSef
SEFAR CapSef are encapsulated filters that install directly in the line without a filter housing. The capsules come in lengths of 2" (62 mm), 5", 10", 20" and 30" and with several inlet and outlet options: 1/4" and 1/2" NPT female or male, 3/8" female NPT, 1"–1 1/2" sanitary connection and hose barb.
| Capsule | Filter medium | Pore rating | Applications according to Sefar |
|---|---|---|---|
| SEFAR CapSef PP | Pleated PP depth medium | 0.1–100 µm | Pre-filtration of bulk chemicals, water, buffers and solvents. Protects membrane filters, removes 99.9% (β = 1000) at the stated pore rating |
| SEFAR CapSef PTFE | Hydrophobic PTFE membrane | 0.1–5 µm | Non-aqueous liquids, aggressive solvents, compressed air, process gas, tank venting and fermenter air |
| SEFAR CapSef PES | Dual-layer PES membrane | 0.03–1 µm | Sterile filtration of WFI, diagnostic solutions, vaccines, ophthalmics, SVP, LVP and biologicals |
| SEFAR CapSef PNY | Nylon 6.6 membrane | 0.1–0.65 µm | Sterilising filtration, sterile filling of SVP, bioburden control in LVP, solvents and WFI |
| SEFAR CapSef PNYPC | Positively charged nylon 6.6 membrane | 0.1–0.65 µm | Sterile filtration and endotoxin reduction in process water and WFI, typically more than 3 log endotoxin |
| SEFAR CapSef PGF | Pleated glass fibre | 0.22–5 µm | Pre-filtration of buffers, culture media, intermediates, SVP and LVP. Removes 99% at the stated pore rating |
Operation, sterilisation and validation of capsules
The test organisms depend on the pore rating: Acholeplasma laidlawii for 0.03 µm, Brevundimonas diminuta for 0.1 and 0.22 µm, Serratia marcescens for 0.45 µm and Saccharomyces cerevisiae for 0.65 µm. For CapSef PNYPC, Sefar states that 0.10 and 0.22 µm meet the FDA definition of a sterilising filter.
- Maximum operating pressure at 20 °C: 5.5 bar for liquids and 4.1 bar for gases
- Operating temperature: 43 °C at 2.1 bar in water. Recommended changeout pressure: 2.4 bar
- Autoclaving at 120–121 °C for 30 minutes, at least 5 cycles (PNYPC at least 25 cycles)
- The capsules are not designed for steam-in-place (SIP) sterilisation. CapSef PP must not be used in steam
- PES and PNY are available both non-sterile and pre-sterilised
- PTFE, PES and PNYPC are validated to ASTM F838-15 with at least 10⁷ organisms per cm² and more than 7 log reduction
Metallic cartridges: SEFAR SinterSef
SEFAR SinterSef are pleated metallic cartridges for high temperatures, cryogenic processes and corrosive environments. They are fully welded with no adhesives or fillers. They withstand 25 bar differential pressure in the normal flow direction (out to in) and 3 bar in reverse with a guard.
The operating temperature is −195 to 340 °C seal limiting and −269 to 1,000 °C alloy limiting. The cartridges are 66 mm in diameter and come in lengths of 5", 10", 20", 30" and 40".
- Catalyst recovery and retention
- Gasification and chemical production
- Vent filters
- Agrochemicals
- Steam filtration, culinary and process steam
- Pharmaceutical powder recovery
| Type | Construction | Pore rating | Material |
|---|---|---|---|
| SEFAR SinterSef F | Pleated sintered metal fibre, low pressure drop and high dirt holding capacity. Can be cleaned in place | 3–60 µm | 316/316L as standard. Inconel 601, Hastelloy X, NiCrMo Alloy 59 and Fecralloy on request |
| SEFAR SinterSef M | Pleated metal mesh in single or multiple layers, also diffusion bonded | 3–250 µm | 316/316L as standard. 304L, Inconel, Hastelloy and Monel on request |
Retention is finer for gases than for liquids. A SinterSef F rated 3 µm gives 1 µm for gases at 99.9% efficiency.
Lengths, end fittings and seals
The standard cartridges are 70 mm in diameter and come in 5" (125 mm), 10" (254 mm), 20" (508 mm), 30" (762 mm) and 40" (1,016 mm). MicroSef WF and PolySef WF have an outer diameter of 154 mm and come in 20", 40" and 60". TekSef A is 63 mm in diameter.
The end caps come in many versions so the cartridges fit filter housings from other manufacturers. The seals are FDA approved for food contact (21 CFR). Seals to USP Class VI are fitted to PHARMA products only.
| Part | Options in the catalogue |
|---|---|
| End fitting | Code 2, Code 3, Code 7, Code 8, Code 28 (fin, 3 lugs), DOE, G DOE (short), N SOE, G SOE, 216 (218), 223, 224, 226, BS832, and F20 with stainless steel core |
| Seal | EPDM (ethylene propylene), silicone, Viton®, nitrile, FEP-encapsulated Viton, FEP-encapsulated silicone, PTFE (DOE) |
| Length | 5", 10", 20", 30", 40". Junior 1.5", 2.5" and 5". Wide format 20", 40" and 60". Capsules 2"–30" |
How to read the order code
The Sefar item number is built up as 31PC, family and length, pore rating, and finally end fitting and seal. The example 31PC-MI30-001-MG means SEFAR MicroSef, 30", 1 µm, DOE fitting and FEP-encapsulated silicone. The pore rating is written with three characters, for example P20 for 0.2 µm and 005 for 5 µm. For capsules, inlet and outlet are given instead of end fitting and seal.
Temperature, pressure and sterilisation
Most pleated disposable cartridges withstand 6.0 bar differential pressure at 20 °C in the normal flow direction and 2.1 bar in reverse. The wide-format cartridges withstand 3.5 bar at 20 °C, must not be loaded in reverse and should be changed at 1.5 bar. TekSef A withstands 3.5 bar at 20 °C.
| Family | Maximum continuous operating temperature | Steam-in-place sterilisation |
|---|---|---|
| MicroSef | 80 °C | 20 × 30 min at 125 °C. Hot water 200 × 20 min at 85–90 °C |
| PolySef 2 | 80 °C | 80 × 30 min at 135 °C |
| TekSef A | 80 °C | Withstands repeated steam sterilisation and hot water |
| BioSef 2 | 85–90 °C | 80 × 30 min at 135 °C |
| BioSef 2 Plus | 85–90 °C | 112 × 20 min at 125 °C |
| BioSef 3 | 80 °C | 20 × 30 min at 135 °C |
| BioSef 3 Plus | 80 °C | 40 × 30 min at 135 °C |
| FluoroSef | 80 °C | 100 × 20 min at 135 °C to 150 × 20 min at 125 °C |
| FluoroSef Plus | 80 °C | 500 × 30 min at 135 °C, or 200 hours at 142 °C |
| VentaSef | Not stated | 70 × 25 min at 135 °C |
| HydroSef and HydroSef Plus | 60 °C | Up to 40 × 25 min at 121 °C |
| MicroSef WF and PolySef WF | Not stated | Steam or autoclave at 121 °C for 15 min. Hot water 90 °C for 30 min, repeated |
Quality levels and regulations
Sefar supplies the cartridges in two quality levels, PHARMA GMP and PHARMA. The difference is that PHARMA GMP covers the complete filter, not just the filter medium.
| Requirement | PHARMA GMP | PHARMA |
|---|---|---|
| Food and drug conformity for the complete filter | Yes | No |
| FDA and EC requirements met for all components | Yes | No |
| All manufacturing to EC 2023/2006 or cGMP (21 CFR 210 ff) | Yes | No |
| Fabrication in a dedicated cleanroom, GMP Class D or ISO Class 8 | Yes | No |
| Food and drug conformity for the filter medium | Yes | Yes |
| Tested for extractables and migration values to EC 10/2011 | Yes | Yes |
| Quality control to ISO 9001 | Yes | Yes |
| PHARMA labels and conductivity certificate (where applicable) | Yes | Yes |
Requirements the cartridges meet
- EC 1935/2004, EC 10/2011, GMP EC 2023/2006 or cGMP, FDA CFR 177 and ISO 9001
- Individual packaging, traceability and quality certificates. Capsules are available pre-sterilised
- Pharmaceutical-grade filters for cGMP manufacture of injectables meet 21 CFR 211.72 and 210.3(b)(6) and USP <788>
- The polymers in BioSef 3 and BioSef 3 Plus meet USP Class VI-121 °C, FDA CFR 21 and EU 10/2011, and the finished cartridge is tested to USP Class VI-121 °C
- BioSef 3, BioSef 3 Plus and HydroSef Junior are validated to USP guidance for extractables, TOC and conductivity, particles and fibre release, and bacterial endotoxins
Integrity testing
Every module of the Sefar membrane cartridges is integrity tested with a diffusion flow test, which is correlated to bacterial challenge testing according to HIMA and ASTM F838-05 (F838-20 for BioSef 3 and BioSef 3 Plus). Users can run their own non-destructive tests such as pressure hold, diffusion flow and bubble point, and for ePTFE also water intrusion. The glass fibre and PP cartridges are batch tested with the bubble point test. The membrane cartridges are cleaned and flushed with pyrogen-free water.
Validation and technical support
Sefar carries out process-specific validations in line with FDA and EU requirements and the Parenteral Drug Association Technical Report No. 26, Sterilizing Filtration of Liquids. The studies are run on pleated filters under worst-case process conditions, because tests on flat membrane do not reflect how a pleated filter behaves under flow. The customer receives a final validation document with the Sefar results and the reports from the independent laboratory.
Sefar has validated filters for antibiotics, vitamins, aggressive solvents and oil-based formulations, high viscosity and high differential pressures, and exposure times up to 80 hours, among others.
- Compatibility: the membrane is tested for bubble point, tensile strength and porometry before and after exposure to the product. O-rings are checked for colour, deformation and weight
- Bacterial challenge: carried out at an independent, FDA-approved laboratory with at least three cartridges from different batches. Brevundimonas diminuta is cultured according to ASTM F838 and the challenge level is more than 1 × 10⁷ CFU/cm². The requirement is zero colonies in the filtrate
- Extractables: under worst-case conditions for temperature, time and pH, usually with a model fluid. Non-volatile residue is measured according to USP <661> and analysed by FTIR if required
- Adsorption: for example how much of a preservative such as benzalkonium chloride in ophthalmic drugs binds to the membrane
- Product-wetted integrity testing: minimum bubble point, test pressure and maximum diffusion flow are determined on at least three filters from different batches
On-site service and training
- Site audit, process filter optimisation and troubleshooting
- Pre-inspection review
- Training in integrity testing and in SIP and CIP methods
Where the cartridges are used in bioprocessing
The catalogue contains process maps that show where Sefar cartridges and capsules sit in pharmaceutical production. The maps use, for example, FluoroSef or FluoroSef Plus 0.2 µm for sterile venting, MicroSef for pre-filtration and BioSef or CapSef PES for bioburden reduction and sterile filtration.
- Aseptic filling
- Harvesting and clarification of fermentation broth
- Microbial fermentation
- Monoclonal antibodies and recombinant proteins
- Plasma fractionation: coagulation factors and albumin
- Vaccines: conjugates, mammalian cells, polysaccharides and viral vectors
- Large and small volume parenterals (LVP and SVP)
- Demineralised water (DM water)
Stainless steel filter housings
Sefar offers sanitary and industrial stainless steel filter housings for 10–20 bar, for single or multiple cartridges and in sizes from 1 to 30 rounds. The housings have in-line BSP connections, with Tri-clover or weld connections as options. A high-pressure series rated for 350 bar is available on request.
- Material: 316/316L stainless steel or Hastelloy, other alloys on request
- Surfaces: welds ground flush and smooth, electropolished, mirror finished, 240 grit surface finish or coating
- Control: solenoid valve and timer
- Pressure vessels to BS5500 and ASME VIII U-stamp. Other standards on request
How Bigman can help
Bigman is the Sefar distributor in Sweden, Norway and Iceland and has worked with Sefar since 1970. We help you choose the family, pore rating, length, end fitting and seal to suit your process and your existing filter housing.
Tell us which housing you have and what needs to be filtered. Always check the current Sefar data sheets before use.
Frequently asked questions
Do Sefar cartridges fit our existing filter housing?
Usually, yes. Sefar has end caps for Code 2, 3, 7, 8 and 28, DOE, SOE, 222, 226 and BS832, among others, so the cartridges can be fitted in existing equipment. Give us the make of the housing and its end code and we will select the right version.
Which cartridge is used for sterilising filtration?
SEFAR BioSef 3 Plus 0.2 µm is the Sefar sterilising cartridge with a PES membrane. Every module is integrity tested by diffusion flow correlated to ASTM F838-20. As capsules there are CapSef PES, PNY and PNYPC, where 0.10 and 0.22 µm in PNYPC meet the FDA definition of a sterilising filter.
What is the difference between PHARMA GMP and PHARMA?
With PHARMA GMP, the complete filter meets food and drug requirements, all components meet FDA and EC requirements, and fabrication takes place in a dedicated GMP Class D / ISO 8 cleanroom to EC 2023/2006 or cGMP. With PHARMA, the requirements apply to the filter medium and its polymers.
Can CapSef capsules be steamed in place?
No. According to Sefar, CapSef capsules are not designed for SIP. They are autoclaved at 120–121 °C for 30 minutes, and the PES and PNY capsules are also available pre-sterilised.