Buffer solutions are used on different stages for pharmaceutical and biotechnological drugs manufacturing such as for chromatography, ultrafiltration, bottling. Typical buffers include sodium acetate, sodium phosphate. Buffer solutions are filtered using membrane filters. Prefilters are used to optimize the filtration process and extend the resource of the final filters.
Process requirements
Typical buffers with a low salt content usually do not require prefiltration.
For buffers with a high concentration of salts or in the presence of low-quality raw materials are recommended to be prefiltered. The combination of the prefilter and the final filter provides a high flow rate and stability of the filter resource.
Purposes of filtration
Prefiltration
- to reduce bioburden and microparticulate pollution before sterilizing filtration.
Final filtration
- to remove bacteria and particles.
Recommendations for filter cartridges
Prefiltration: depth prefilters EPV.SC or EPV.S.
For high-quality prefiltration of buffers with high salt concentration, we recommend depth prefilters EPV.SC or EPV.S with micron rating of 0.5-0.8 μm. The filter cartridegs of these series are capable of providing high flow rates, excellent mechanical and thermal resistance, high efficiency of microparticle retention, do not emit fibers into the filtrate, manufactured according to ISO 9001: 2000.
Final filtration: EPM.PS.
For the final sterilizing filtration, we recommend a membrane filter EPM.PS-045/020 based on a high-performance asymmetric polyethersulfone membrane.
Sterilizing air filtration ("breathing" filters): EPM.F4.
We recommend membrane filter cartridges made of polytetrafluoroethylene EPM.F4 with 0.2 μm pore size.
Filter housings: DS-1-D(-/-)M – sanitary construction.
For the organization of the filtration process we propose the body equipment - the filter housing of the series DS sanitary construction made from high-quality steel AISI 316L or AISI 304.
Integrity test: TECHNOCHEK.
Device for monitoring the integrity of membrane filtration systems - TECHNOCHEK.
For the final choice of the scheme for the filtration process of buffer solutions, please contact specialists of NPP “Technofilter”.