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.

Aseptic processing area, clean room maintenance check with EU Annexure 1, given clarity about this. Which is published on 22 . 08.2023 .

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