Standard

We follow following International Standards, Codes and Norms for Sterile Liquid Processing System as a primary requirement of CGMP practice.

  • Mechanical Standards
    Vessels : ASME Sec. VIII Div.1, AD-Merkblatt, ASME BPE
    Heat Exchangers : TEMA
  • GMP Standards
    USFDA, WHO, cGMP, EHEDG, FDA, ASME (BPE), A 3, ISPE Baselines, ISO-14159
  • European Nations Stds FOR CE Marking
    Vessel Design : EN – 13445
    NDT Standards : EN – 1435, 895, 12517 & 571
    Safety Standards : DS/EN 1050
    Hygienic Design : B3 EN 1672 – 2
  • Qualification Documents & Execution Standards
    ISPE Baselines Vol 5
  • Equipments Layout Standards
    ISPE Baselines Vol.3
  • PIPING STANDARDS
    (BPE) / SA 270
    Utility : ANSI B 31.3
  • Automation Standards
    GAMP5 & 21 CFR Part 11
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