• A true FDA compliant filter bag
•Certified to the most stringent standards
•FDA compliant, single bag packaging
•Customised labelling
•Full traceability
•Test report
SEFAR PHARMA GMP Bags is the certified filter bag solution for the pharmaceutical industry. The design has been developed to avoid possible contamination from staple fibres coming from the needle felt.
An ePTFE microporous membrane laminated on the polyester or PTFE needle felt gives it its high filtration efficiency. The high-conductivity stainless steel matrix incorporated in the antistatic version provides excellent protection against explosion. The manufacturing process of the SEFAR PHARMA GMP Bags is compliant with EU 2023/2006 GMP. All the materials used conform to both EU 10/2011 and FDA CFR’s.
SEFAR PHARMA GMP Bags are tailor-made, in accordance with the specific dimension and manufacturing detail required by the equipment. Pura Tex also provides cartridge filter bags to your specifications to suit your industry in Australia and New Zealand.
EC 1935/2004
EC 10/2011
GMP EC 2023/2006 or cGMP
FDA CFR 177
ISO 9001
ATEX (EC 94/9)
Single packaging Customized labelling
Traceability
1 High conductivity stainless steel matrix to provide excellent protection against explosion
2 ePTFE membrane – to avoid contamination and provide high filtration efficiency
3 PET or PTFE scrim – for high mechanical resistance and stability
4 EC compliant polyester or PTFE needle felt
5 High-performance edge design
Product Code | Material | Felt Weight g | PTFE Membrane | Antistatic |
07-550-50 NFMA PHARMA | Polyester | 550 | Yes | Yes |
07-550-50 NFM PHARMA | Polyester | 550 | Yes | No |
24-750-50 NFM PHARMA | PTFE | 750 | Yes | No |