Guidelines for Aseptic Processing

what are the parameters and guidelines for aseptic processing, clean steam, water for injection?

Pure steam parameters

  1. Non condensable gas: NMT 3.5%
  2. Dryness value: NLT 90%
    3)pH of steam condensate: 5-7 at 25 degree temp.
    4)Conductivity: NMT 1.3 us/cm
    5)Endotoxin test: 0.25 EU/mL

WFI parameters:
1)pH of steam condensate: 5-7 at 25 degree temp.
2)Conductivity: NMT 1.3 us/cm
3)Endotoxin test: 0.25 EU/mL
4)TOC : NMT 500ppm

For Aseptic process simulation you should read PDA guideline.