Guide lines and Standards
We follow following International Standards, Codes and Norms for Sterile Liquid Processing System as a primary requirement of cGMP practice.
- Vessels :
ASME Sec. VIII Div.1,
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
- 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
- Process : (BPE) / SA 270
- Utility : ANSI B 31.3
- 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