Clean Steam Analysis

Clean steam is critical in pharmaceutical manufacturing and sterile services, where it is used for sterilisation, humidification, and direct contact with product-contact equipment. To ensure safety, regulatory compliance, and sterility assurance, clean steam must meet strict physical, chemical, and microbiological standards.

At Honeyman Laboratories, we provide full clean steam analysis, in partnership with our site engineers at  Honeyman Water, in alignment with EN 285, HTM 01-01 (Part D), and pharmacopoeial requirements for water quality (WFI).

What We Test

Our clean steam analysis covers all key parameters:

Physical quality (EN 285 criteria):

  • Dryness fraction ≥ 0.95
  • Non-condensable gases ≤ 3.5% v/v
  • Superheat ≤ 25 K
  • Chemical Purity:
  • Chlorides, silica, sodium, ammonia and other ionic contaminants benchmarked against WFI specifications
  • Conductivity and pH
  • Microbiological Quality:
  • Total viable count (TVC)
  • Absence of specified microorganisms
  • Endotoxin testing using LAL methods
  • Why Clean Steam Testing Matters

    Non-compliant clean steam can cause failed sterilisation cycles, corrosion of product-contact equipment, contamination risk, and inspection findings. Routine analysis demonstrates control of your utility systems and ensures compliance with MHRA, EMA, FDA and HTM 01-01 expectations.

    Why Choose Honeyman

  • MHRA-approved GMP laboratory with validated clean steam methods
  • Onsite GMP-trained samplers to ensure aseptic, reliable collection
  • Validated transport to maintain sample integrity
  • Audit-ready reports with expert interpretation, CAPA guidance and trending support
  • Integrated support from Honeyman Water for system design, upgrades and troubleshooting
  • Complete Lifecycle Support

    From commissioning and qualification through to ongoing monitoring and troubleshooting, Honeyman offers full lifecycle support for your clean steam systems. Our expertise ensures your facility is inspection-ready, compliant, and safe.

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