Features

  • Enhanced performance and energy savings
  • Sleek mechanical construction in SS 316L
  • Joints are orbitally welded with video-boroscope
  • All contact parts are electropolished to less than 0.4 RA microns
  • Complies with USFDA 21 CFR part 11, GAMP 5 and ASME

Design and Quality Compliance Standards

  • GMP and cGMP
  • USFDA 21 CFR part 11
  • ISPE ‘Baseline® Guide, Volumes 4, 5 and 8
  • GAMP 5
  • ASME