Steam Quality Testing

  • Custom protocol consulting and development, or seamless execution of your own protocols.
  • Quickly-delivered, quality-reviewed qualification documentation for confidence and compliance.

 

Choose Masy for Accurate Calibration

Ensuring Compliance by Performing your Steam Quality Qualification

In addition to sterilizer qualification, Masy BioServices offers steam quality testing. For compliance, pharmaceutical manufacturers must have documented evidence that the steam supply used in any large steam sterilizer meets the standards set in the European standard EN 285. The three SQ1 steam quality tests used to provide this evidence are Non-Condensable Gases, Superheat, and Dryness. These tests are performed as the sterilizer runs through its operating cycle. We also offer SQ2 steam quality testing for point-of-use applications.

The Non-Condensable Gases test measures quantities of non-condensable gases, such as nitrogen and carbon dioxide, which can dilute the steam and effectively insulate the sterilizer load, thus reducing the sterilization efficacy. 

The Superheat test indicates superheated steam, which is steam at a temperature above its boiling point for the corresponding pressure. This steam will not condense until the temperature is lowered to the boiling point of water at the operating pressure, reducing sterilization efficacy. Some causes of superheat include the chamber jacket temperature exceeding the chamber temperature and excessive decrease in steam pressure close to the point of use.

The Dryness test measures the moisture content of the steam. The ratio of steam to water is directly related to the latent heat the steam possesses. Steam with high moisture content contains less energy than pure saturated steam and will not sterilize effectively. Steam with too little moisture can superheat when expanding within the chamber, preventing condensation from occurring and reducing sterilization efficacy.

Another available option for steam quality testing is using an SQ2 sample cooler to take condensate samples for TOC, microbial and conductivity testing from steam or heated water systems. This method is more common in plant or utility boiler rooms, and is ideal for testing at multiple points in a system.

 

Masy's Approach to Calibration

The Correct Steam Quality Test Certificate for Your Specific Requirements

Masy BioServices will supply the procedures and the test equipment for the steam testing. All equipment used is calibrated and NIST-traceable. Successful steam quality testing ensures that the steam supply to sterilizers is of an acceptable grade and compliant to EN 285 and the Choice Framework for local Policy and Procedures (CFPP) 01-01. We can provide you with our established steam quality test certificate in accordance with US Food and Drug Administration, current good manufacturing practices (cGMP) and other cGxP guidelines. 


Fast Calibration Turnaround Time

Post-Qualification Verification of Qualification Test Equipment Confirms Accuracy

All certified test equipment used at our customer sites are verified upon return to our NVLAP-accredited metrology laboratory. This completes the physical execution of the test activity that took place at your facility. No other validation company provides this level of confidence that their equipment is accurate, stable and repeatable.

Additionally, our own credentialed Quality Department will review all certificates before delivery to ensure our final product to you meets our exacting standard. We also retain a digital copy of your completed report to assist you with future audit questions, should the need arise.


Contact Masy for Calibration

Fast Turnaround Time Keeps your Operations On-Schedule

We understand that your equipment being out-of-tolerance, or down for validation testing, can negatively impact your production schedules and capacity. We will supply enough personnel and equipment to complete the project within your specified timeframe.

 

Contact Masy for Calibration

Choose Masy BioServices for your Steam Quality Testing Needs

When you choose Masy for your steam quality testing, you can enjoy the confidence that comes with knowing that your critical equipment has been tested to meet the highest possible standard, ensuring compliance with your SOPs and cGMP regulation – keeping your materials and products safe and effective.


Contact Masy BioServices today for your steam quality testing needs

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