Filtration & Separation Solutions

Embrace Ultimate Application Challenges of Filtration, Separation, and Purification Technology

Lyophilized Powder Injections Filtration

 

The key of sterile production in the lyophilized powder injection process is controlling the sterilization and disinfection processes, which often determines the qualification of pharmaceutical products.

 

The upgrade of filtration equipment and filter materials, as well as the improvement of detection equipment, have effectively ensured the sterility requirements of lyophilized powder injection production. Taking sterilizing filtration products as an example, different filter membranes are used for different medications. At the same time, the application of filter integrity testing devices can detect the integrity of filter membranes and the airtightness of the filtration system. They provide reliable protection for the sterility of semi-finished products.

 

In order to safeguard the production process from external environmental influences, vent filters should be used in the mixing tank and dilution tank. PTFE cartridge and single-layer membrane will be sufficient.

 

For decarbonization filtration, titanium rod filters are recommended.

 

For pre-filtration to remove particle impurities, polypropylene (PP) filters with larger pore sizes can be used to remove large particles and protect the subsequent filters with smaller pore sizes. For the removal of small particle impurities and reduction of microbial load, polyethersulfone (PES) filters can be used, which provide good filtration efficiency and ensure the flux and service life of the terminal sterilizing filter.

 

For redundant filtration and terminal sterilizing filtration, filters of the same type and micron rating are used. Generally, a double-layer folded PES filter with 0.22 μm is used, which can achieve the sterilization level required by GMP regulations. 

 

The use of a double-layer filter ensures better sterilization effectiveness. However, the flux may be affected in high drug concentrations or low filtration temperatures. In this event, pre-filtration is employed to ensure the efficiency of terminal filtration, such as 1 μm polypropylene (PP) filter + 0.65 μm polypropylene (PP) filter + 0.45 μm PES filter. Multiple-stage filtration greatly improves the effectiveness and efficiency of terminal sterilization, as well as ensuring the service life of the filters and controlling costs effectively.

 

Complete Filtration Management

 

At Feature-Tec, we provide comprehensive pharmaceutical filtration solutions. Our experienced filtration experts will thoroughly understand your process requirements and recommend the appropriate filtration system. From deep pre-filtration to terminal sterilizing filters, Feature-Tec's  products are widely used in clarification, sterilization, and vent filtration processes, ensuring a more cost-effective and reliable pharmaceutical production.

 

•Effective reduction of bioburden

•Increased product yield

•Long service life

•Effective protection for downstream sterilization

•Filters chemically compatible with pharmaceutical liquids.

 

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