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  1.

    Product Specification Sheet for Planova™ BioEX Virus Removal Filters

    Document type
    Product Specification Sheet
    Corresponding product
    Planova™ BioEX filters
    Document number
    TAE33013 version 3.0
    Date of issue
    Jun 1, 2020

  2. Instructions for Use Planova™ BioEX Virus Removal Filters

    Document type
    Usage Precautions/ Instructions for Use
    Corresponding product
    Planova™ BioEX filters
    Document number
    TAE33012 version 3.0
    Date of issue
    Jun 1, 2020

  3. Operating Procedure 0.19 ㎡ BioOptimal™ MF-SL Module

    Document type
    User Guide/SOP
    Corresponding product
    BioOptimal™ MF-SL with effective surface area of 0.19m²
    Document number
    TAS33030-1.3
    Date of issue
    Dec 25, 2019

  4. Safety Data Sheet for BioOptimal™ MF-SL

    Document type
    Safety Data Sheet
    Corresponding product
    BioOptimal™ MF-SL Microfilters
    Document number
    TAQ35068-1.2
    Date of issue
    Dec 25, 2019

  5. Operating Procedure 1㎡ BioOptimal™ MF-SL Module

    Document type
    User Guide/SOP
    Corresponding product
    BioOptimal™ MF-SL with effective surface area of 1m²
    Document number
    TAS33062-1.2
    Date of issue
    Oct 1, 2018

  6. Operating Procedure 0.005㎡ BioOptimal™ MF-SL Module

    Document type
    User Guide/SOP
    Corresponding product
    BioOptimal™ MF-SL with effective surface area of 0.005m²
    Document number
    TAS33058-1.3
    Date of issue
    Oct 1, 2018

  7. Operating Procedure 8㎡ BioOptimal™ MF-SL Module

    Document type
    User Guide/SOP
    Corresponding product
    BioOptimal™ MF-SL with effective surface area of 8m²
    Document number
    TAS33048-1.0
    Date of issue
    Nov 22, 2019

  8. Validation Report Planova™ 15N, 20N and 35N Filter Integrity Tests Liquid Forward-Flow Rate (LFR) Test

    Document type
    Validaiton Report
    Corresponding product
    Planova™ 15N, 20N & 35N Filters
    - Filters
    Document number
    TAS34027 version 1.1
    Date of issue
    Oct 1, 2018

  9. Integrity Test Procedure for Planova™ 15N, 20N and 35N Filters: Liquid Forward-Flow Rate (LFR) Test

    Document type
    User Guide/SOP
    Corresponding product
    Planova™ 15N, 20N & 35N Filters
    - Filters
    Document number
    TAS33009 version 2.0
    Date of issue
    Mar 25, 2019

  10. Integrity Test Procedure for Planova™ 15N, 20N, 35N and 75N Filters - Visual Leakage Test -

    Document type
    User Guide/SOP
    Corresponding product
    Planova™ 15N, 20N, 35N and 75N filters
    Document number
    TAS33088-1.1
    Date of issue
    Feb 25, 2019

  11. Planova™ Leak Tester Maintenance Procedures

    Document type
    Corresponding product
    Planova™ Leak Tester PLT-AM10
    Document number
    TAS33073-1.3
    Date of issue
    Oct 1, 2018

  12. Planova™ Leak Tester Periodical Calibration Procedures

    Document type
    Corresponding product
    Planova™ Leak Tester PLT-AM10
    Document number
    TAS33072-1.3
    Date of issue
    Oct 1, 2018

  13. Planova™ Leak Tester Routine Calibration Procedures

    Document type
    Corresponding product
    Planova™ Leak Tester PLT-AM10
    Document number
    TAS33071-1.3
    Date of issue
    Oct 1, 2018

  14. Planova™ Leak Tester Operations Manual

    Document type
    Corresponding product
    Planova™ Leak Tester PLT-AM10
    Document number
    TAS33070-1.3
    Date of issue
    Oct 1, 2018

  15. Planova™ Leak Tester Instruction for Use

    Document type
    Corresponding product
    Planova™ Leak Tester PLT-AM10
    Document number
    TAS33069-1.3
    Date of issue
    Oct 1, 2018

  16. Integrity Test Kit Sample Certificate of Analysis (AGP-HA35S)

    Document type
    Sample Certificate of Analysis (COA)
    Corresponding product
    Asahi Integrity Test Solution Kit (Gold Particle Test Kit) AGP-HA35S
    Document number
    MAQ41510-17-2.0
    Date of issue

  17. Integrity Test Kit Sample Certificate of Analysis (AGP-HA35M)

    Document type
    Sample Certificate of Analysis (COA)
    Corresponding product
    Asahi Integrity Test Solution Kit (Gold Particle Test Kit) AGP-HA35M
    Document number
    MAQ41510-17-2.0
    Date of issue

  18. Integrity Test Kit Sample Certificate of Analysis (AGP-HA20S)

    Document type
    Sample Certificate of Analysis (COA)
    Corresponding product
    Asahi Integrity Test Solution Kit (Gold Particle Test Kit) AGP-HA20S
    Document number
    MAQ41510-17-2.0
    Date of issue

  19. Integrity Test Kit Sample Certificate of Analysis (AGP-HA20M)

    Document type
    Sample Certificate of Analysis (COA)
    Corresponding product
    Asahi Integrity Test Solution Kit (Gold Particle Test Kit) AGP-HA20M
    Document number
    MAQ41510-17-2.0
    Date of issue

  20. Integrity Test Kit Sample Certificate of Analysis (AGP-HA15S)

    Document type
    Sample Certificate of Analysis (COA)
    Corresponding product
    Asahi Integrity Test Solution Kit (Gold Particle Test Kit) AGP-HA15S
    Document number
    MAQ41510-17-2.0
    Date of issue

  21. Integrity Test Kit Sample Certificate of Analysis (AGP-HA15M)

    Document type
    Sample Certificate of Analysis (COA)
    Corresponding product
    Asahi Integrity Test Solution Kit (Gold Particle Test Kit) AGP-HA15M
    Document number
    MAQ41510-17-2.0
    Date of issue

  22. Planova™ 75N Sample Certificate of Analysis (1.0 m2)

    Document type
    Sample Certificate of Analysis (COA)
    Corresponding product
    Planova™ 75N filters with effective surface area of 1.0 m2
    Document number
    MAQ41510-16-2.0
    Date of issue

  23. Planova™ 75N Sample Certificate of Analysis (0.3 m2)

    Document type
    Sample Certificate of Analysis (COA)
    Corresponding product
    Planova™ 75N filters with effective surface area of 0.3 m2
    Document number
    MAQ41510-16-2.0
    Date of issue

  24. Planova™ 75N Sample Certificate of Analysis (0.01 m2)

    Document type
    Sample Certificate of Analysis (COA)
    Corresponding product
    Planova™ 75N filters with effective surface area of 0.01 m2
    Document number
    MAQ41510-16-2.0
    Date of issue

  25. Planova™ 75N Sample Certificate of Analysis (0.001 m2)

    Document type
    Sample Certificate of Analysis (COA)
    Corresponding product
    Planova™ 75N filters with effective surface area of 0.001 m2
    Document number
    MAQ41510-16-2.0
    Date of issue

  26. Planova™ 35N Sample Certificate of Analysis (0.001 m2)

    Document type
    Sample Certificate of Analysis (COA)
    Corresponding product
    Planova™ 35N filters with effective surface area of 0.001 m2
    Document number
    MAQ41510-16-2.0
    Date of issue

  27. Planova™ 35N Sample Certificate of Analysis (0.01 m2)

    Document type
    Sample Certificate of Analysis (COA)
    Corresponding product
    Planova™ 35N filters with effective surface area of 0.01 m2
    Document number
    MAQ41510-16-2.0
    Date of issue

  28. Planova™ 35N Sample Certificate of Analysis (0.12 m2)

    Document type
    Sample Certificate of Analysis (COA)
    Corresponding product
    Planova™ 35N filters with effective surface area of 0.12 m2
    Document number
    MAQ41510-16-2.0
    Date of issue

  29. Planova™ 35N Sample Certificate of Analysis (0.3 m2)

    Document type
    Sample Certificate of Analysis (COA)
    Corresponding product
    Planova™ 35N filters with effective surface area of 0.3 m2
    Document number
    MAQ41510-16-2.0
    Date of issue

  30. Planova™ 35N Sample Certificate of Analysis (1.0 m2)

    Document type
    Sample Certificate of Analysis (COA)
    Corresponding product
    Planova™ 35N filters with effective surface area of 1.0 m2
    Document number
    MAQ41510-16-2.0
    Date of issue

  31. Planova™ 35N Sample Certificate of Analysis (4.0 m2)

    Document type
    Sample Certificate of Analysis (COA)
    Corresponding product
    Planova™ 35N filters with effective surface area of 4.0 m2
    Document number
    MAQ41510-16-2.0
    Date of issue

  32. Planova™ 20N Sample Certificate of Analysis (0.3 m2)

    Document type
    Sample Certificate of Analysis (COA)
    Corresponding product
    Planova™ 20N filters with effective surface area of 0.3 m2
    Document number
    MAQ41510-16-2.0
    Date of issue

  33. Planova™ 20N Sample Certificate of Analysis (0.12 m2)

    Document type
    Sample Certificate of Analysis (COA)
    Corresponding product
    Planova™ 20N filters with effective surface area of 0.12 m2
    Document number
    MAQ41510-16-2.0
    Date of issue

  34. Planova™ 20N Sample Certificate of Analysis (1.0 m2)

    Document type
    Sample Certificate of Analysis (COA)
    Corresponding product
    Planova™ 20N filters with effective surface area of 1.0 m2
    Document number
    MAQ41510-16-2.0
    Date of issue

  35. Planova™ 20N Sample Certificate of Analysis (4.0 m2)

    Document type
    Sample Certificate of Analysis (COA)
    Corresponding product
    Planova™ 20N filters with effective surface area of 4.0 m2
    Document number
    MAQ41510-16-2.0
    Date of issue

  36. Planova™ 20N Sample Certificate of Analysis (0.01 m2)

    Document type
    Sample Certificate of Analysis (COA)
    Corresponding product
    Planova™ 20N filters with effective surface area of 0.01 m2
    Document number
    MAQ41510-16-2.0
    Date of issue

  37. Planova™ 20N Sample Certificate of Analysis (0.001 m2)

    Document type
    Sample Certificate of Analysis (COA)
    Corresponding product
    Planova™ 20N filters with effective surface area of 0.001 m2
    Document number
    MAQ41510-16-2.0
    Date of issue

  38. Planova™ 15N Sample Certificate of Analysis (0.001 m2)

    Document type
    Sample Certificate of Analysis (COA)
    Corresponding product
    Planova™ 15N filters with effective surface area of 0.001 m2
    Document number
    MAQ41510-16-2.0
    Date of issue

  39. Planova™ 15N Sample Certificate of Analysis (0.01 m2)

    Document type
    Sample Certificate of Analysis (COA)
    Corresponding product
    Planova™ 15N filters with effective surface area of 0.01 m2
    Document number
    MAQ41510-16-2.0
    Date of issue

  40. Planova™ 15N Sample Certificate of Analysis (0.12 m2)

    Document type
    Sample Certificate of Analysis (COA)
    Corresponding product
    Planova™ 15N filters with effective surface area of 0.12 m2
    Document number
    MAQ41510-16-2.0
    Date of issue

  41. Planova™ 15N Sample Certificate of Analysis (0.3 m2)

    Document type
    Sample Certificate of Analysis (COA)
    Corresponding product
    Planova™ 15N filters with effective surface area of 0.3 m2
    Document number
    MAQ41510-16-2.0
    Date of issue

  42. Planova™ 15N Sample Certificate of Analysis (1.0 m2)

    Document type
    Sample Certificate of Analysis (COA)
    Corresponding product
    Planova™ 15N filters with effective surface area of 1.0 m2
    Document number
    MAQ41510-16-2.0
    Date of issue

  43. Planova™ 15N Sample Certificate of Analysis (4.0 m2)

    Document type
    Sample Certificate of Analysis (COA)
    Corresponding product
    Planova™ 15N filters with effective surface area of 0.01 m2
    Document number
    MAQ41510-16-2.0
    Date of issue

  44. Planova™ BioEX Sample Certificate of Analysis (0.01 m2)

    Document type
    Sample Certificate of Analysis (COA)
    Corresponding product
    Planova™ BioEX filters with effective surface area of 0.01 m2
    Document number
    MAQ41510-24-2.0
    Date of issue

  45. Planova™ BioEX Sample Certificate of Analysis (0.0003 m2)

    Document type
    Sample Certificate of Analysis (COA)
    Corresponding product
    Planova™ BioEX filters with effective surface area of 0.0003 m2
    Document number
    MAQ41510-24-2.0
    Date of issue

  46. Planova™ BioEX Sample Certificate of Analysis (0.001 m2)

    Document type
    Sample Certificate of Analysis (COA)
    Corresponding product
    Planova™ BioEX filters with effective surface area of 0.001 m2
    Document number
    MAQ41510-24-2.0
    Date of issue

  47. Planova™ BioEX Sample Certificate of Analysis (0.1 m2)

    Document type
    Sample Certificate of Analysis (COA)
    Corresponding product
    Planova™ BioEX filters with effective surface area of 0.1 m2
    Document number
    MAQ41510-24-2.0
    Date of issue

  48. Planova™ BioEX Sample Certificate of Analysis (1.0 m2)

    Document type
    Sample Certificate of Analysis (COA)
    Corresponding product
    Planova™ BioEX filters with effective surface area of 1.0 m2
    Document number
    MAQ41510-24-2.0
    Date of issue

  49. Planova™ BioEX Sample Certificate of Analysis (4.0 m2)

    Document type
    Sample Certificate of Analysis (COA)
    Corresponding product
    Planova™ BioEX filters with effective surface area of 4.0 m2
    Document number
    MAQ41510-24-2.0
    Date of issue

  50. Validation Report for BioOptimal™ MF-SL Microfilters

    Document type
    Validation Report
    Corresponding product
    BioOptimal™ MF-SL Microfilters
    Document number
    TAS34039 version 4.1
    Date of issue
    Oct 1, 2018

  51. BioOptimal™ MF-SL Microfilters Precautions for Use

    Document type
    Usage Precautions/ Instructions for Use
    Corresponding product
    BioOptimal™ MF-SL Microfilters
    Document number
    TAE33004 version 5.0
    Date of issue
    Oct 1, 2018

  52. Safety Data Sheet for Asahi Integrity Test Solution Kits

    Document type
    Safety Data Sheet
    Corresponding product
    Asahi Integrity Test Solution Kits (AGP-HA15, AGP-HA20 and AGP-HA35)
    Document number
    TAQ35005 version 3.2
    Date of issue
    Nov 9, 2018

  53. Validation Report for Planova™ BioEX Filter Integrity Tests - Horizontal Visual Leakage Test -

    Document type
    Validation Report
    Corresponding product
    Planova™ BioEX filters
    Document number
    TAS34062 version 2.1
    Date of issue
    Oct 1, 2018

  54. Validation Report for Planova™ BioEX Filter Integrity Tests

    Document type
    Validation Report
    Corresponding product
    Planova™ BioEX filters
    Document number
    TAS34060 version 2.1
    Date of issue
    Oct 1, 2018

  55. Planova™ BioEX Filter Validation Report

    Document type
    Validation Report
    Corresponding product
    Planova™ BioEX filters
    Document number
    TAS34036 version 4.1
    Date of issue
    Oct 1, 2018

  56. Integrity Test Procedure for Planova™ BioEX Filters - Horizontal Visual Leakage Test -

    Document type
    User Guide/SOP
    Corresponding product
    Planova™ BioEX filters
    Document number
    TAS33074 version 2.1
    Date of issue
    Oct 1, 2018

  57. Integrity Test Procedure for Planova™ BioEX Filters - Visual Leakage Test -

    Document type
    User Guide/SOP
    Corresponding product
    Planova™ BioEX filters
    Document number
    TAS33064 version 2.1
    Date of issue
    Oct 1, 2018

  58. Integrity Test Procedure for Planova™ BioEX Filters - Leakage Test Performed with the Planova™ Leak Tester -

    Document type
    User Guide/SOP
    Corresponding product
    Planova™ BioEX filters and Planova™ Leak Tester (PLT-AM10)
    Document number
    TAS33065 version 2.1
    Date of issue
    Oct 1, 2018

  59. Filtration Procedure for Planova™ BioEX

    Document type
    User Guide/SOP
    Corresponding product
    Planova™ BioEX filters
    Document number
    TAS33054 version 5.1
    Date of issue
    Oct 1, 2018

  60. Validation Report on Asahi Integrity Test Kit AGP-HA35

    Document type
    Validation Report
    Corresponding product
    Asahi Integrity Test Solution Kits (AGP-HA35)
    Document number
    TAS34020 version 3.0
    Date of issue
    Mar 15, 2019

  61. Validation Report on Asahi Integrity Test Kit AGP-HA20

    Document type
    Validation Report
    Corresponding product
    Asahi Integrity Test Solution Kits (AGP-HA20)
    Document number
    TAS34017 version 3.0
    Date of issue
    Mar 15, 2019

  62. Validation Report on Asahi Integrity Test Kit AGP-HA15

    Document type
    Validation Report
    Corresponding product
    Asahi Integrity Test Solution Kits (AGP-HA15)
    Document number
    TAS34019 version 3.0
    Date of issue
    Mar 15, 2019

  63. AGP-HA Asahi Integrity Test Solution Kit Instructions for Use

    Document type
    Usage Precautions/ Instructions for Use
    Corresponding product
    Asahi Integrity Test Solution Kits (AGP-HA15, AGP-HA20 and AGP-HA35)
    Document number
    TAE33018 version 2.0
    Date of issue
    Sep 1, 2018

  64. Validation Report for Planova™ 15N, 20N, 35N and 75N Filters: Leakage Test Performed with the Planova Leak Tester (PLT)

    Document type
    Validation Report
    Corresponding product
    Planova™ Leak Tester (PLT-AM10)
    Document number
    TAS34021 version 2.0
    Date of issue
    Mar 25, 2019

  65. Integrity Test Procedure for Planova™ 15N, 20N, 35N and 75N Filters: Leakage Test Performed with the Planova Leak Tester (PLT)

    Document type
    User Guide/SOP
    Corresponding product
    Planova™ 15N, 20N, 35N and 75N filters, PLT-AM10
    Document number
    TAS33036 version 2.0
    Date of issue
    Mar 25, 2019

  66. Integrity Test Procedure Planova™ 15N, 20N and 35N Filters Gold Particle Test (GPT) Using the Asahi Integrity Test Solution Kit

    Document type
    User Guide/SOP
    Corresponding product
    Planova™ 15N, 20N, 35N and 75N filters
    Document number
    TAS33031 version 3.1
    Date of issue
    Feb 25, 2019

  67. Product Specification Sheet for Planova™ Virus Removal Filters

    Document type
    Product Specification Sheet
    Corresponding product
    Planova™ 15N, 20N, 35N and 75N filters
    Document number
    TAE33015-2.0
    Date of issue
    Oct 1, 2018

  68. Planova™ 35N Filter Validation Report

    Document type
    Validation Report
    Corresponding product
    Planova™ 35N filters
    Document number
    TAS34012 version 4.0
    Date of issue
    Feb 25, 2019

  69. Planova™ 20N Filter Validation Report

    Document type
    Validation Report
    Corresponding product
    Planova™ 20N filters
    Document number
    TAS34010 version 4.0
    Date of issue
    Feb 25, 2019

  70. Planova™ 15N Filter Validation Report

    Document type
    Validation Report
    Corresponding product
    Planova™ 15N filters
    Document number
    TAS34014 version 4.0
    Date of issue
    Feb 25, 2019

  71. Planova™ 75N Filter Validation Report

    Document type
    Validation Report
    Corresponding product
    Planova™ 75N filters
    Document number
    TAS34016 version 3.0
    Date of issue
    Feb 25, 2019

  72. Instructions for Use Planova™ Virus Removal Filters

    Document type
    Usage Precautions/ Instructions for Use
    Corresponding product
    Planova™ 15N, 20N, 35N and 75N filters
    Document number
    TAE33014 version 2.0
    Date of issue
    Oct 1, 2018

  73. Filtration Procedure for Planova™

    Document type
    User Guide/SOP
    Corresponding product
    Planova™ 15N, 20N, 35N and 75N filters
    Document number
    TAS33004 version 4.0
    Date of issue
    Feb 25, 2019