The complexity of modern medical technology and the wide variety of sterilization techniques and equipment has made effective sterility assurance programs highly challenging. Important tasks and duties of sterile service departments include staff training, maintenance and calibration of equipment, sterilization process control and traceability of processed items and loads.
Chemical indicators are designed to provide data concerning the conditions inside the sterilizing chamber and to alert the user to potential faults in the sterilization process or loading errors. The chemical indicators provide a reliable and stable record for long-term documentation. The relevant European EN and international ISO standards stipulate essential design and performance requirements for chemical indicators.
Modern indicators like Wipak’s unique Steriking® Daily Control test packs serve as a simple and reliable record of the sterilization process and they also grade any faults detected. This disposable test pack examines for steam penetration and detects air leaks. It offers added sensitivity for diagnosing steam quality.
The new, unique ink technology accurately examines the Bowie & Dick test cycle in a pre-vacuum sterilizer. Comparing the test results from day to day provides a valuable early warning system with regard to cycle faults. The indicator system sensitively detects abnormal cycle or sterilizer problems and signals effectively any trend towards wet steam that would jeopardize the sterilization process. Beyond the EN requirements the clear, differential colour changes also provide a warning about the presence and severity of wet steam levels.
The Steriking® test pack complies with EN 867-4: 2001 and satisfies requirements for air removal by subatmospheric and superatmospheric pulsing and also for transatmospheric conditions with insufficient air removal.
Permanent reaction for reliable records
The initial white colour changes in the course of sterilization through brown shades to black and continues beyond black to shades of grey. The clear endpoint reaction is stable for at least 20 years. There is no colour reversion after use.
Any brown discoloring of the indicator sheet indicates incomplete processing. Under-exposure can be due to insufficient time or temperature. An incomplete or spotty brown is caused by insufficient air removal, an air leak during the air removal stage, the presence of non-condensable gases in the steam supply or a poorly fitted door or other faulty gasket.
A colour change beyond the black endpoint to a uniform greyish colour indicates overprocessing either due to excessive processing time or temperature. Grey, shiny or silvery spots or streaks signal the presence of excessive moisture. Shiny spots cause no concern if the processed load is dry after the sterilization process. Control of spot accumulation facilitates a decision on early phase maintenance. Cycles longer than described in EN 867-4 may cause the indication of excessive moisture.
Steriking® monitoring products bring an extra degree of control to the sterilization process. The product range also includes Class D multi-parameter steam and EO gas indicators that correspond to critical parameters in the sterilization cycle, enabling the process conditions to be monitored by a simple and practical method.
Steriking® indicator tapes are printed with Class A process indicators for steam, dry heat and EO gas sterilization. They have been specially developed for the tight and safe closure of sterilization packages.
Steriking® pouches and rolls are well known for their reliable performance and safety in use. These packaging materials are supplied with high-quality and reliable Class A process indicators for all known sterilization methods. Clear colour contrasts help differentiate between sterilized and non-sterilized loads.
Chemical indicators are unable to guarantee the sterility of items in the pack, but biological indicators and sterilizer instrumentation also fail to provide such a guarantee. Chemical indicators help detect machine and human errors in the preparation, packaging and loading of supplies, and in operating the autoclave. They provide a simple and reliable control and complete the sterilization assurance programs.