Qualification of pure steam

Qualification of pure steam used in pharmaceutical applications (in steam sterilizers for sterilization of parts, instruments, and assemblies, porous loads, in SIP systems) is an essential part of the quality assurance system of delivered products. 

You may order clean steam testing or perform this procedure yourself, but you will need a test kit to do this. 

Qualification of pure steam is documented evidence that: 

  • the level of non-condensable gases contained in the steam will not prevent the attainment of sterilization conditions in any part of the sterilizer load; 

  • the excess moisture carried in aerosol will not cause damp loads;  

  • the amount of moisture in suspension with steam from the service supply is sufficient to prevent the saturated steam from becoming superheated during expansion into the sterilizer chamber; 

  • the quality of pure steam condensate (bacterial endotoxins, total organic carbon, and conductivity) is within specifications. 

Main stages and duration: 




Protocol development

  • Obtaining information from a customer; 
  • Preliminary review of provided documentation; 
  • Development of qualification protocol. 

5 days


  • Identification of checkpoints and methods of connection; 
  • Feed water sampling for analysis;  
  • Monitoring of non-condensable gases, steam dryness, and superheating; 
  • Steam condensate sampling and its transfer to the laboratory; 
  • Filling out qualification protocol forms. 

1-2 days

Report development

  • Analysis of the obtained results; 
  • Calculation of test results; 
  • Summary and conclusions; 
  • Elaboration of recommendations. 

5 days

Our advantages: 

  • We have extensive experience in testing pure steam generation and distribution systems; 

  • We run these tests on a regular basis and are confident in the results; 

  • Our testing laboratory is equipped with the most up-to-date quality control equipment for pure steam made in the USA & UK. 

Qualification of pure steamstages: 

  • DQ Design qualification; 

  • IQ - Installation qualification; 

  • OQ - Operation qualification; 

  • PQ - Performance qualification. 

Qualification of pure steam is performed under the following standards: 

  • DIN 58950 Sterilization – Steam sterilizers for pharmaceutical products Part 7: Requirements on services and installation; 

  • DIN EN 13824 Sterilization of medical devices – Aseptic processing of liquid medical devices – Requirements; 

  • ISPE Baseline Pharmaceutical Engineering Guide, Volume 4: Water and Steam Guide; 

  • DIN EN 285 Sterilization – Steam Sterilizers – Large Sterilizers; 

  • HTM 2010 Sterilization. 

Quality control of steam using modern equipment made in the UK and the USA.

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The guarantee of high-quality products and services!