Steam Quality Testing
CTG has all of the necessary equipment and expertise to conduct Steam Quality Testing at your facility!
Offering an expert staff of unmatched experience and exceptional client support, CTG is the premier service provider of Steam Quality Testing (SQT) throughout North America. CTG experts have successfully executed testing at hundreds of locations for dozens of clients across the US and Canada, and have the knowledge and experience to assist in troubleshooting when failures occur. We offer independent testing in order to accurately measure steam conditions in compliance with HTM 2010 and EN 285 standards. CTG's SQT service can assist in identifying adverse steam conditions that may be negatively impacting product quality, productivity, downtime and energy use.
Our service includes a comprehensive summary report, complete with all original field documents, testing requirements, calculations, test results, recommendations and applicable equipment calibration certificates. Read our Steam Quality Testing Frequently Asked Questions (FAQ) section below and contact us to learn more about our Steam Quality Testing service and CTG's commitment to deliver on the promise of world-class responsiveness and service.
Steam is a vapor with heat transfer properties ideally suited for sterilization. Steam quality is expressed in terms of saturation. Understanding steam characteristics and the effects on the sterilization process– specifically pharmaceutical grade steam produced via Clean Steam or Pure Steam Generators –can be quite complex. The contents of this Frequently Asked Questions (FAQ) section are intended to serve as a general introduction to Steam Quality Testing for CTG's present and future clients, rather than detailed or definitive documentation on the topic. Contact us for greater detail or further questions.
What is Steam Quality Testing (SQT)?
Based upon Health Technical Memorandum 2010, British Standard European Norm 285 (EN 285) provides the European standard for steam sterilization, defining the required steam characteristics and limits for effective sterilization. Pharmaceutical manufacturers seeking to provide product to the EU must have the ability to provide documented evidence that the steam supplied to any large sterilizer (typically autoclaves, though not exclusively) used in the manufacturing of that product has been tested and meets the stated requirements.
How is steam quality measured?
In order to provide information of the steam quality, three separate tests are conducted; Non-Condensable Gases Test, Superheat Test and Dryness Value Test. Each test provides information which together, ensures that the steam is of sufficient quality to comply with EN 285 standards. Wet steam, superheated steam and high levels of non-condensable gases entrained within the steam all have the ability to negatively impact proper sterilization.
Non-Condensable gases represent impurities entrained in the steam, typically air though other gases may be present as well. A high level has the potential to lower steam temperature inside the chamber, in effect insulating the media and adversely impacting the sterilization process.
Superheated steam is defined as steam at a temperature above its boiling point for its pressure. Steam that is superheated cannot condense without a temperature drop to the boiling point at the given pressure, essentially rendering the steam as hot air, rather than steam vapor.
- A continuous supply of dry saturated steam is required in order to achieve the ideal conditions for sterilization to occur. The Dryness Value of steam is determined by measuring the moisture content carried within the vapor. Wet steam carries less energy than dry steam, adversely impacting the steam’s sterilizing properties, and may cause damp loads. Steam that is lacking appropriate moisture content may become superheated during expansion in the chamber.
Which sterilizers need to be tested?
It is important to note that the sterilizer itself is not being tested. Rather, it is the steam being supplied to the sterilizer that is subject to SQT. The requirements of EN 285 are specific to “Large Steam Sterilizers”. However, good practice would suggest that any steam sterilizer used for GMP product can and perhaps should have the steam supply studied in order to create a baseline of information to assist with any future sterilization issues. This may include any SIP stations, Stopper Washers and even Fermentors used for GMP purposes.
What are the facility requirements for SQT?
In order to properly conduct testing, the test equipment is connected directly to the steam supply line via three connection ports. It is important that they are installed in the proper location with regard to components (valves, regulators, elbows) of the steam supply to the subject sterilizer. CTG can provide detailed information or assistance with regard to appropriate installation requirements and supply in line testing elbows.
What is the testing frequency?
Testing frequency is determined by the end user, as EN 285 does not specify an exact testing frequency. Typically, SQT is performed annually or bi-annually in conjunction with sterilizer validation maintenance or re-qualification. However, it is not uncommon for facilities to have the steam tested at a higher frequency in order to assist with any effort to identify steam-related sterilization issues, or to re-test after a shut down period.
Is SQT only for pharmaceutical manufacturers?
Does CTG perform SQT at Pure Steam/Clean Steam Generators?
Does CTG offer training on the use of test kits?
