• Laboratory for Air Filter
  • Laboratory for Filter Cartridge
    • Testing System for HEPA/ULPA
    • Testing System for Pre-Filter
    • Advantages

      Automatic testing procedure is set by standard EN1822-4
      Continuously test mass filters effectively
      Automatically generate reports
      Flexibly adapt to different filters’ dimensions
      Customizing testing report
      Convenient control and data acquisition software

      Principle

      With the tested filter installed in the detector bracket, it detects the air flow with aerosol. The rear-end scanning probe with particle counters can automatically do leak detection and test filtration efficiency, thus record the relevant data.
      The data acquisition as well as the control of the entire system is done by the PC placed on a separate movable computer desk.
      Throughout the whole testing process (scan), the air concentrations in upstream and downstream are measured continuously by different particle counters. In downstream filtration efficiency is detected and the potential leaking risks displayed.

       

      The graph represents the local filtration efficiency. It is very easy to identify potential leaking risks.
    • Advantages

      The test rig has been developed for air filter testing according to standards EN 779 and ASHRAE 52.2
      Rotatable and movable duct sections
      Universal filter holding system
      Online testing the dust holding capacity
      Highly automatically. All the test, data acquisition and reports are run by a complete procedure automatically

      The following parameters of the filter under test can be detected:

      Differential pressure and efficiency
      Dust holding capacity
      Average efficiency in different dust generating phases

      Main window of the software for test rig control as well as data acquisition and evaluation.

      Dust sections:
      1、Mixing chamber
      3、Filter sample chamber
      5、Duct section with protection filter
      2、 Measuring chamber of the raw gas
      4、Measuring chamber of the clean gas and the terminal filter
      6、Volume flow rate measuring system
    • Extractables Validation
    • Chemical Compatibility Validation
    • Adsorption Evaluation
    • Bacteria Rejection Test
    • Recycle Use Verification
    • Water Intrusion Test for Gas Filter
    • Integrity Validation
    • Bacteria Viability Test
    • Laboratory Equipment

      Lenge Purification Equipment Co., Ltd. and Jiangnan University established the Institute of materials and technology, and the graduate-student workstation. With advanced imported test equipment, standard test procedures and testing proposals, we can provide customers with various test and validation services, such as chemical compatibility, extractables, adsorption, bacterial challenge, bacterial viability, integrity, recycle use, etc.
      For different customers, we simulate the produce process under the most disadvantage conditions, and make qualitative and quantitative estimation of dissolution by imported infrared spectrometer, ultraviolet spectrophotometer, HPLC and other equipment, thus make the quantitative analysis of the product absorbed on the membrane.

      Purpose

      The qualitative analysis and quantitative estimates of dissolved matter from the filter in the contacting process of the technology under the worst conditions.

      Principle and method selection

      The sources of dissolved matter include: the filter hardware, supporting layer, filter membrane, wetting agent and other additives maybe used in the processing. Extracted the filter from the model volatile solvent, by quantitative detection of non-volatile residue (NVR), and then qualitative analysis of ultraviolet-visible spectrum and infrared visible spectrum, if necessary, increase the analysis of dissolved matter.
    • Laboratory Equipment

      Lenge Purification Equipment Co., Ltd. and Jiangnan University established the Institute of materials and technology, and the graduate-student workstation. With advanced imported test equipment, standard test procedures and testing proposals, we can provide customers with various test and validation services, such as chemical compatibility, extractables, adsorption, bacterial challenge, bacterial viability, integrity, recycle use, etc.
      For different customers, we simulate the produce process under the most disadvantage conditions, and make qualitative and quantitative estimation of dissolution by imported infrared spectrometer, ultraviolet spectrophotometer, HPLC and other equipment, thus make the quantitative analysis of the product absorbed on the membrane.

      Purpose

      Make sure that the filter and the fluid are chemistry-compatible and confirm that the process will not change the performance of the filter.

      Principle and method selection

      The filter and liquid contacted for a specified time under given condition, the chemical compatibility is judged by, contacting before and after, the integrity, flow rate, weight, appearance and Scanning Electron Microscope(SEM) of the filter and membrane.

      PES membrane SEM
    • Laboratory Equipment

      Lenge Purification Equipment Co., Ltd. and Jiangnan University established the Institute of materials and technology, and the graduate-student workstation. With advanced imported test equipment, standard test procedures and testing proposals, we can provide customers with various test and validation services, such as chemical compatibility, extractables, adsorption, bacterial challenge, bacterial viability, integrity, recycle use, etc.
      For different customers, we simulate the produce process under the most disadvantage conditions, and make qualitative and quantitative estimation of dissolution by imported infrared spectrometer, ultraviolet spectrophotometer, HPLC and other equipment, thus make the quantitative analysis of the product absorbed on the membrane.

      Purpose

      The fluid absorbed on the filter may effects the composition or concentration of the fluid. The absorbable filter materials include membrane, hardware and supporting material.

      Principle and method selection

      In the processing of technology development, adsorption test generally applied on a small scale and confirm on a large scale. The quantitative analysis by using High Performance Liquid Chromatography(HPLC) is designed to establish pretreatment selection, operating parameters and membrane selection.

      Chromatogram
    • Laboratory Equipment

      Lenge Purification Equipment Co., Ltd. and Jiangnan University established the Institute of materials and technology, and the graduate-student workstation. With advanced imported test equipment, standard test procedures and testing proposals, we can provide customers with various test and validation services, such as chemical compatibility, extractables, adsorption, bacterial challenge, bacterial viability, integrity, recycle use, etc.
      For different customers, we simulate the produce process under the most disadvantage conditions, and make qualitative and quantitative estimation of dissolution by imported infrared spectrometer, ultraviolet spectrophotometer, HPLC and other equipment, thus make the quantitative analysis of the product absorbed on the membrane.

      Purpose

      The evidence shows that the filtration process can continue to remove high levels of standard bacterial or related microbial contamination of the product or substitute liquid suspended under the simulated process conditions.

      Principle and method selection

      Sterilized filter means each centimeter of effective filtration area of the filter can trap 107CFU brevundimonas bullata (ATCC19146) under specified technology. Although there’s unified bacteria-intercepted standard for air filter, due to the liquid bacteria challenge regards as the “worst condition” of the air filter, it is widely accepted referring the liquid filter’s test.
    • Laboratory Equipment

      Lenge Purification Equipment Co., Ltd. and Jiangnan University established the Institute of materials and technology, and the graduate-student workstation. With advanced imported test equipment, standard test procedures and testing proposals, we can provide customers with various test and validation services, such as chemical compatibility, extractables, adsorption, bacterial challenge, bacterial viability, integrity, recycle use, etc.
      For different customers, we simulate the produce process under the most disadvantage conditions, and make qualitative and quantitative estimation of dissolution by imported infrared spectrometer, ultraviolet spectrophotometer, HPLC and other equipment, thus make the quantitative analysis of the product absorbed on the membrane.

      Purpose

      Sterilized filter should be discarded after each batch use. However, if you want to reuse it in the next batch, then you need to verify the maximum batches it could be re-used.

      Principle and method selection

      Verification is necessary when reuse liquid sterilizing grade filter to produce medicine. It include but not limited to: repeated technology and methods, simulating actual reuse under the worst condition to get the validation parameters, which include repeat sterilization, flux, pressure differences and thus doing the integrity test base on the parameters.
    • Laboratory Equipment

      Lenge Purification Equipment Co., Ltd. and Jiangnan University established the Institute of materials and technology, and the graduate-student workstation. With advanced imported test equipment, standard test procedures and testing proposals, we can provide customers with various test and validation services, such as chemical compatibility, extractables, adsorption, bacterial challenge, bacterial viability, integrity, recycle use, etc.
      For different customers, we simulate the produce process under the most disadvantage conditions, and make qualitative and quantitative estimation of dissolution by imported infrared spectrometer, ultraviolet spectrophotometer, HPLC and other equipment, thus make the quantitative analysis of the product absorbed on the membrane.

      Purpose

      Due to the hydrophobic property, organic solvent need to be used in bubble point test as wetting agent. Use pure water will avoid the solvent cleaning and residue.

      Principle and method selection

      At low pressure, the hydrophobic membrane prevents the water through, but there's still a little measurable water evaporation flow when lower than water breakthrough pressure (water is through by pressed), which is similar to the diffusion flow of the wetted membrane.
    • Laboratory Equipment

      Lenge Purification Equipment Co., Ltd. and Jiangnan University established the Institute of materials and technology, and the graduate-student workstation. With advanced imported test equipment, standard test procedures and testing proposals, we can provide customers with various test and validation services, such as chemical compatibility, extractables, adsorption, bacterial challenge, bacterial viability, integrity, recycle use, etc.
      For different customers, we simulate the produce process under the most disadvantage conditions, and make qualitative and quantitative estimation of dissolution by imported infrared spectrometer, ultraviolet spectrophotometer, HPLC and other equipment, thus make the quantitative analysis of the product absorbed on the membrane.

      Purpose

      Calculate the diffusion flow, pressure maintenance or bubble point limiting value of the humid filter under the specified temperature.

      Principle and method selection

      The integrity parameters of the humid filter which consist of diffusion flow limiting value, detection pressure and minimum bubble point, are calculated by the test data when the filter is wet and corresponding parameters of the reference solution.
    • Laboratory Equipment

      Lenge Purification Equipment Co., Ltd. and Jiangnan University established the Institute of materials and technology, and the graduate-student workstation. With advanced imported test equipment, standard test procedures and testing proposals, we can provide customers with various test and validation services, such as chemical compatibility, extractables, adsorption, bacterial challenge, bacterial viability, integrity, recycle use, etc.
      For different customers, we simulate the produce process under the most disadvantage conditions, and make qualitative and quantitative estimation of dissolution by imported infrared spectrometer, ultraviolet spectrophotometer, HPLC and other equipment, thus make the quantitative analysis of the product absorbed on the membrane.

      Purpose

      Prove the brevundimonas bullata in aqueous solution are trapped rather than in a specific product is not enough to verify the filter could meet the requirement of aseptic filtration technology in the production process.

      Principle and method selection

      To choose the right challenge test method, the tested microorganism should be directly inoculated to the carrying fluid (product or substitute) to prove its survivability. To the non-sterilized technology and fluid, the preferred method for bacteria viability test is: the tested microorganism directly inoculated to the product. While testing the sterilized product, it should increase bacterial concentration or choose substitute according to the sterilization grade.
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