Pharma and life science
SEFAR PHARMA GMP for pharmaceutical production
We supply Sefar fabricated filter fabrics for drying, filtration and centrifugation in the pharmaceutical industry: fluid bed dryer bags, filter bags, centrifuge bags, centrifuge liners and filter nutsche cloths. In the SEFAR® PHARMA GMP quality level they are made in a dedicated cleanroom, GMP Class D / ISO Class 8, with traceability for all critical parts.
- Dedicated cleanroom, GMP Class D
- ISO 8
- Quality levels: PHARMA GMP, PHARMA and Standard
- 3
- Nominal pore size, SEFAR TETEX DLW
- 7–120 µm
- Air permeability, fluid bed dryer bags
- 65–430 l/(m²·s)
Three quality levels
Sefar supplies the filter fabrics in three quality levels: PHARMA GMP, PHARMA and Standard. Choose PHARMA GMP when the complete filter, not just the fabric, must be documented and made to GMP.
| Requirement | PHARMA GMP | PHARMA | Standard |
|---|---|---|---|
| Food and drug conformity for the complete filter | Yes | No | No |
| FDA and EC requirements met for all components | Yes | No | No |
| All production processes and fabrication to EC 2023/2006 or equivalent cGMP | Yes | No | No |
| Fabrication in a dedicated cleanroom, GMP Class D or ISO Class 8 | Yes | No | No |
| Food and drug conformity for the filter medium | Yes | Yes | No |
| Tested for extractables and migration values to EC 10/2011 | Yes | Yes | No |
| Food and drug compliant polymers in the filter medium | Yes | Yes | Yes |
| Quality control to ISO 9001 | Yes | Yes | Yes |
| PHARMA label (where applicable) | Yes | Optional | Optional |
| Conductivity certificate for the complete filter (where applicable) | Yes | Optional | Optional |
From yarn to finished filter
Sefar controls every critical production step, from yarn manufacture to finished filter. This gives full traceability for all critical parts. According to Sefar, the PHARMA GMP products were developed together with leading pharmaceutical manufacturers, and the GMP products are made in Sefar cleanrooms under strict GMP guidelines.
Two in-house technologies recur across the whole range:
- Welded seams: no particles escape through stitching holes
- Labelling: clear identification and traceability, customer-defined text, no contamination, no fading or shedding
Fluid bed dryer bags
The fluid bed dryer bags are made from SEFAR TETEX MULTI. The fabrics are conductive and all articles in the table are antistatic. Sefar describes them as offering the best retention at the highest permeability.
All skirt options are available for easy installation, for example with cord or zipper, and the caps are tailor-made to fit the dryer.
| Article | Material | Air permeability (l/(m²·s)) | Weight (g/m²) |
|---|---|---|---|
| 03-110-168 WA PHARMA | PA | 110 | 168 |
| 07-65-180 WA PHARMA | PET | 65 | 180 |
| 07-100-150 WA PHARMA | PET | 100 | 150 |
| 07-200-150 WA PHARMA | PET | 200 | 150 |
| 07-300-150 WA PHARMA | PET | 300 | 150 |
| 07-430-140 WA | PET | 430 | 140 |
Requirements the bags meet: EC 1935/2004, EC 10/2011, GMP EC 2023/2006 or cGMP, FDA CFR 177 and ISO 9001. They are conductivity tested, individually packed, labelled to customer specification and traceable.
Filter bags with membrane
Sefar filter bags for the pharmaceutical industry are built up in four layers. The edge is designed so that fibres from the needle felt do not contaminate the product.
- Polyester or PTFE needle felt that meets EC requirements
- PET or PTFE scrim for mechanical strength and stability
- ePTFE membrane that prevents contamination and gives high filtration efficiency
- High-conductivity stainless steel matrix for protection against explosion
| Article | Material | PTFE membrane | Antistatic | Weight (g/m²) |
|---|---|---|---|---|
| 07-550-50 NFMA PHARMA | PET | Yes | Yes | 550 |
| 07-550-50 NFM PHARMA | PET | Yes | No | 550 |
| 24-750-50 NFM PHARMA | PTFE | Yes | No | 750 |
In addition to EC 1935/2004, EC 10/2011, GMP EC 2023/2006 or cGMP, FDA CFR 177 and ISO 9001, the filter bags meet ATEX (EC 94/9). They are supplied with a test report, individually packed and traceable.
Centrifuge bags and centrifuge liners
The centrifuge bags are made from SEFAR TETEX DLW, a double-layer weave with an integrated drainage layer. Sefar states best particle retention, best cake release and reduced installation and maintenance time, which gives higher production capacity. The bags are adapted to the customer’s centrifuge.
| Article | Material | Air permeability (l/(m²·s)) | Nominal pore size (µm) | Weight (g/m²) |
|---|---|---|---|---|
| 05-8000-SK 007 PHARMA | PP | 30 | 7 | 420 |
| 05-8000-SK 008 PHARMA | PP | 40 | 8 | 420 |
| 05-8000-SK 012 PHARMA | PP | 50 | 12 | 455 |
| 05-8000-K 020 PHARMA | PP | 100 | 20 | 425 |
| 05-8000-SK 030 PHARMA | PP | 200 | 30 | 440 |
| 05-8000-K 050 PHARMA | PP | 400 | 50 | 440 |
| 05-8000-K 085 PHARMA | PP | 600 | 85 | 440 |
| 05-8000-W 120 PHARMA | PP | 1,700 | 120 | 425 |
| 17-8000-SK 008 PHARMA | PEEK | 45 | 8 | 586 |
| 17-8000-SK 020 PHARMA | PEEK | 100 | 20 | 586 |
| 17-8000-K 040 PHARMA | PEEK | 300 | 40 | 586 |
| 17-8000-SK 085 PHARMA | PEEK | 800 | 85 | 512 |
Centrifuge bags, inverting centrifuge bags and centrifuge liners meet EC 1935/2004, EC 10/2011, GMP EC 2023/2006 or cGMP, FDA CFR 177 and ISO 9001, and are supplied individually packed, labelled and traceable.
Inverting centrifuge bags
Inverting filter centrifuges use SEFAR TETEX MULTI, with the best particle retention, good strength and flexibility, and SEFAR TETEX MONO, with the best particle retention at the highest permeability and good cleaning properties. The seams are welded.
| Article | Type | Material | Air permeability (l/(m²·s)) | Nominal pore size (µm) | Weight (g/m²) |
|---|---|---|---|---|---|
| 05-1001-SK 025 | Monofilament | PP | 30 | 25 | 272 |
| 05-1100-SK 014 PHARMA | Monofilament | PP | 100 | 14 | 136 |
| 05-1050-SK 025 PHARMA | Monofilament | PP | 95 | 25 | 210 |
| 05-4-660 K PHARMA | Multifilament | PP | 4 | Not stated | 660 |
| 05-11-360 SK PHARMA | Multifilament | PP | 11 | Not stated | 360 |
| 05-12-330 W PHARMA | Multifilament | PP | 12.5 | Not stated | 320 |
| 05-22-300 W PHARMA | Multifilament | PP | 22 | Not stated | 300 |
| 17-10-240 K PHARMA | Multifilament | PEEK | 10 | Not stated | 235 |
| 17-25-240 W PHARMA | Multifilament | PEEK | 25 | Not stated | 235 |
Centrifuge liners
Centrifuge liners are available endless, overlap welded or butt welded (head-to-head), for minimal plough tolerance. The edges are supplied with ribbon, taped or cut to suit the equipment. The liners are available in the same SEFAR TETEX DLW grades as in the table above.
Filter nutsches and horizontal filter discs
For filter nutsches and horizontal filter discs, Sefar has PEEK fabrics with high temperature resistance and high chemical resistance. The fabrics are also available in SEFAR TETEX DLW, SEFAR TETEX MULTI and SEFAR TETEX MONO, with the same articles as for centrifuges. The Sefar table for nutsche cloths also lists the PP monofilament fabric 05-1550-K 053 PHARMA, with a nominal pore size of 53 µm, 170 l/(m²·s) and 300 g/m².
The edge is hemmed, taped, fitted with cord or laser cut.
Materials
The fabrics are made from polyamide (PA), polyester (PET), polypropylene (PP), PEEK and PTFE. The needle felt in the filter bags is polyester or PTFE. The fluid bed dryer fabrics weigh 140–180 g/m², TETEX DLW 420–586 g/m², and the filter bags 550 g/m² (PET) and 750 g/m² (PTFE).
Filter cartridges, capsules and filter housings
For liquid and gas filtration we supply SEFAR PHARMA GMP Cartridges: cartridges, capsules, metallic cartridges and filter housings, from 250 µm down to 0.03 µm absolute. Sefar pharmaceutical-grade filters are intended for cGMP manufacture of injectables and meet 21 CFR 211.72 and 210.3(b)(6) and USP <788>.
Sefar also offers validation services according to FDA, EU and PDA Technical Report No. 26: compatibility, bacterial challenge, extractables, adsorption and product-wetted integrity testing. More on the filter cartridges page.
Applications
The fabrics are used in the solid-liquid separation and drying steps of pharmaceutical production: fluid bed drying, filtration, centrifugation and nutsche filtration. The Sefar filter cartridge catalogue also lists the following processes and products:
- Active pharmaceutical ingredients (API) and biopharmaceuticals
- Fermentation, harvesting and clarification
- Monoclonal antibodies and recombinant proteins
- Plasma fractionation
- Vaccines
- Large and small volume parenterals (LVP and SVP) and ophthalmics
- Deionised water and WFI
Bigman and Sefar
Bigman is the Sefar distributor in Sweden, Norway and Iceland and has worked with Sefar since 1970. We advise on fabric and design, and supply fabric by the running metre or as fabricated parts to suit your equipment.
Products we have developed for you can be stocked in Spånga, so your flow of goods does not stop. The lead time is given once the product has been developed.
Frequently asked questions
What is the difference between PHARMA GMP and PHARMA?
With PHARMA GMP, the requirements apply to the complete filter. All components meet FDA and EC requirements, all manufacturing follows EC 2023/2006 or cGMP, and fabrication takes place in a dedicated GMP Class D / ISO Class 8 cleanroom. With PHARMA, the requirements apply to the filter medium, which is tested for extractables and migration values to EC 10/2011.
Why are the seams welded instead of stitched?
Sefar welds the seams so that no particles can pass through stitching holes.
Are antistatic or ATEX-rated versions available?
Yes. All fluid bed dryer fabrics in the Sefar table are antistatic and the bags are conductivity tested, with a conductivity certificate where applicable. The filter bags have a stainless steel matrix and meet ATEX (EC 94/9).
Can the bags be adapted to our machine?
Yes. Sefar tailors caps, skirts, cords, zippers and edge designs to the customer’s equipment. Give us the make and dimensions of the machine and we will draw up a proposal.