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CPSG – Documentation

CPSG  production range 1


(data realease of the following list can change without notice, Bram-Cor always works with up-to-date certifications)

  • United States Pharmacopoeia (USP)
  • European Union Pharmacopoeia (EP)
  • EudraLex – The Rules Governing Medicinal Products in the European Union – Vol. 4: Good Manufacturing Practice-Medicinal Products for Human and Veterinary Use
  • Sterile Manufacturing facilities – ISPE Guideline
  • Water & steam systems – European Pharmacopoeia current edition USP  – ISPE Guideline
  • Testing GXP – ISPE Guideline
  • Commissioning and Qualification , Vol.5 – ISPE Guideline
  • Commissioning and Qualification of Water and Steam Systems, current edition – ISPE Guideline
  • Approaches to Commissioning and Qualification of Water and Steam Systems  – ISPE Guideline
  • Calibration Management, current edition – ISPE Guideline
  • 2006/42/CE European Directive for Machinery, current edition
  • 2014/68/UE Eur. Directive for Pressure Vessels (repl. PED 97/23/CE)
  • ASME BPVC Boiler and Pressure Vessel Code – S / U stamp certified
  • GAMP 5: “A risk-based approach to compliant GXP computerized systems”
  • CFR 21 Part 11: FDA guideline for electronic records and electronic signatures
  • ASME BPE “Bioprocessing Equipment”
  • UNI EN 9606:2013 – “Qualification of welders” – Manual welding
  • UNI EN 14732:2013 “Qualification of welders” – Automatic welding
  • A270 ASTM – “Standard Specification for Seamless and Welded Austenitic Stainless Steel Sanitary Tubing
  • A269 ASTM – “Standard Specification for Seamless and Welded Austenitic Stainless Steel Tubing for General Service
  • A479 ASTM “Standard Spec. for Stainless Steel Bars and Shapes for Use in Boilers and Other Pressure Vessels”
  • A967 ASTM – “Standard Specification for Chemical Passivation Treatments for Stainless Steel Parts”
  • CEI EN 60204-1:“Electrical safety of machinery”
  • IEC 1131-1: “Programmable Controllers – General Information”
  • UNI 10893: “Technical Documentation of Product”
  • UNI EN 10204: “Metallic products – type of inspection documents”
  • ASTM C-795 “Standard Specification for Thermal Insulation for Use in Contact with Austenitic Stainless Steel”
  • UNI 5634 “Identification of piping for fluids”
  • ASTM A380 “Standard Practice for Cleaning, Descaling, and Passivation of Stainless Steel Parts, Equipment and Systems”
  • EN 285 “Sterilization, steam sterilizers, large sterilizers (related to Bram-Cor CPSG/Pure Steam Generator)