Filter Testing

Sterilization by filtration is a major unit operation used in an aseptic manufacturing process. It requires appropriate process validation to verify the performance of filter used in the sterilizing filtration. Filter testing is used to evaluates the ability of a filter to separate out various sizes of microbial organisms, as well as help manufacturers to determine membrane pore sizes. This test is also an excellent lot release test. Test data can also be used as an effective marketing tool.

Standard for Filter Testing

"Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice", the FDA guidance document for industry, gives out the general considerations that FDA considers should be taken into account when performing filter testing for a medical device.

Our Filter Testing Service

• Sterilization Validation

  Demonstrate the sterilization method is effective and does not compromise the filter.

• Retention Capacity and Filtration Efficiency Test

  Demonstrate the ability of filter to remove bacteria from the liquid bacterial suspension under defined conditions according to ASTM 838-05.

  During validation of filtration processes, all the factors which can affect the filter performance, such as pH, viscosity and compatibility with the filter of the filtered material, flow rates, pressures, temperature, and hydraulic shock will be taken into consideration.

• Filter Extractables Test

  Identify and quantify the compounds which have the potential to become leachables.

• Filter Leachables Test

  Identify, quantify, and evaluate the impact of compounds that migrate from filter to process stream.

• Binding Test

  Demonstrate the filter does not remove stream components.

• Integrity Test

  Demonstrate the filter’s bacterial retention capabilities using a non-destructive test.

• Compatibility Test

  Demonstrate the stream has no adverse effect on the filter.

• Stability Test

  Demonstrate the filter has no adverse effect on the process stream.

• Fit for Use

  Demonstrate the filter satisfies all requirements within product & process conditions. Includes but not limited to resistance to high temperature, resistance to pressure and flow variation fatigue, resistance to high change in pressure, etc.

• End Load Test
• Absolute Filtration Speed
• Bubble Point Test
• Gas Diffusion Test
• Pressure Hold Test
• Pore Size Measurement and Validation

Measure and verify the pore size of membrane filter media with molecular templates or particles, including bacteria in known size

With extensive expertise in Filter Testing, STEMart can provide a full-service experience, support manufacturers to meet the regulatory goals, and minimize the compliance risks. If you have additional questions about Filter Testing or would like to find out more about our services, please feel free to contact us.