THERMO DIAGNOSTICS.

TESTING AND VALIDATION STANDARDS FOR STEAM QUALITY

For the Facility Manager or Validation Engineer
What are the steam quality testing standards?

For US healthcare facilites, we do steam quality testing according to ANSI/AAMI ST79, comprehensive guide to steam sterilization and sterility assurance in health care facilities (2010), for pharmaceutical firms and Canadian healthcare facilities we follow European Standard EN285 Sterilization. Steam sterilizers. Large sterilizers.

Sterilizers and autoclaves are critical components in health care, life sciences, institutional, and research facilities... but since they are open-ended steam users, poor steam quality (water in the line) can cause major problems.

Test steam quality at access point, with a direct (dead weight) calorimeter. The test requires a sampling tube (we provide) inserted in the steam supply pipe. A few pounds of steam is condensed in a water reservoir. Weight and temperature changes allow the steam quality to be calculated (also called "dryness fraction" in the European standards.). Noncondensable gas (NCG) ratio to condensate, and superheat levels are also tested.

Sterilizers and autoclaves are critical components in health care, life sciences, institutional, and research facilities...

Differences:

1. The major difference in the standards is the steam dryness or steam quality (also called dryness fraction in EN285). The EN285 standard allows 95% dryness for metal loads and 90% for porous or liquid loads. The ST79 standard requests 97% dryness.
2. The other difference in the overall goal of each standard. ST79 deals with how to run a sterile processing DEPARTMENT, from equipment layout to wrapping and decontamination procedures. EN285 on the other hand deals with how to VALIDATE a large sterilizer, including the design of the installation, and ongoing maintenance tests (of which steam quality testing is part).

THERMO DIAGNOSTICS

STERILIZER WET PACK ARTICLES

Read some of our articles about sterilizer wet packs, stains, and steam quality:

THERMO DIAGNOSTICS

TIME LINE

A typical solution involves:

1. Request for proposal - We try to have a written quote** for you the same day as the RFP.
2. Data acquisition - We need whatever pictures, log sheets, drawings, sketches, and problem statements you can offer.
3. Steam Quality Testing - Typically a one-day site visit. We require a knowledgeable escort, since we start at the problem site, and work our way back to the steam source.
4. Solution and resolution - We will review all findings before leaving the site, or as directed.

We will promptly (48-72 hours) deliver a written report documenting testing and inspection results. Corrective action steps and follow ups will be clearly spelled out.