Steam Quality Testing
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 nott 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 autoclave 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 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.
Contact Masy BioServices today for your steam quality testing needs.