Standards

Design Guidelines, Testing & Inspection

Guide lines and Standards

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-Merkblatter,
    ASME BPE 2012,
    ASTM B912, "Standard Specification for Passivation of Stainless Steel Using Electropolishing"
    ASTM A967, "Standard Specification for Chemical Passivation Treatments for Stainless Steel Parts"
    ASTM A380, "Standard Practice for Cleaning, Descaling, and Passivation of Stainless Steel Parts, Equipment, and Systems"
    GTAW & Orbital Welding
  • Heat Exchangers : TEMA

GMP Standards

  • USFDA, WHO, cGMP, EHEDG, FDA, ASME (BPE), A 3, ISPE Baselines, ISO-14159

Qualification Documents & Execution Standards

  • ISPE Baselines Vol 5

Equipments Layout Standards

  • ISPE Baselines Vol.3

Piping Standards

  • Process : (BPE) / SA 270
  • Utility : ANSI B 31.3

Automation Standards

  • GAMP5 & 21 CFR Part 11

Third Party Inspection – On request – TUV Inspection

Testing & Inspection – Radiography Test, Dye Penetrant Test, Hydro Static Test, Spray Ball Coverage Test (Riboflavin Test), Ra Finish Test, Boroscopy Test, Steam Sterilization, Software Bench Test

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