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事业领域

BIO & Pharmaceutical Plant

我们提供以Bio-Pharmaceutical Plant实施经验为基础,符合cGMP, ASME BPE 以及相关规格的最完美的解决方案.

APPLICATION STANDARD

  • ASME Bioprocessing Equipment
  • AWS D18.2, Guide to weld discoloration levels on the inside of austenitic stainless steel tube
  • ASME Boiler and Pressure Vessel Code, Section IX, Welding and Brazing Qualifications
  • ASME Boiler and Pressure Vessel Code, Section V, Nondestructive Examination
  • ASME B31.3, Process Piping
  • ASTM A270, Specification Seamless and Welded Austenitic Stainless Sanitary Tubing
  • ASTM A380, Practice, for Cleaning, Descaling, and Passivation of Stainless Steel Parts, Equipment and Systems
  • FDA, 21 CFR, Parts 210 and 211, current Good Manufacturing
  • cGMP current Good Manufacturing Practices
  • Industrial Standards(KS, DIN, etc.)
  • ENGINEERING

    Conceptual Design / Basic Design / Detail Design / Field Engineering / Passivation Plan

  • PROCUREMENT

    Equipment / Technical Evaluation / Expediting Service

  • CONSTRUCTION

    Process System / Utility System / Automation

  • VALIDATION

    DQ·IQ·OQ Support / E 2500 Verification Support / Documentation & Report