Consolidated Sterilizer Systems (CSS) services

Installation Qualification (IQ) provides documentary evidence that the equipment has been built and installed to specification, and that all supporting services (i.e., utilities such as electricity, water, and steam) are available and connected properly. The IQ process methodically documents all aspects of the installation, the machine components, and any testing equipment used to provide a complete, closed-loop assessment. In addition, IQ includes NIST traceable calibration verification of the unit’s critical components.

Operational Qualification (OQ) provides documented evidence that the sterilizer operates in accordance with design specifications. The OQ validation examines the autoclave’s ability to run the sterilization process correctly and to respond appropriately to error conditions, assuring that the sterilizer performs as intended.

Performance Qualification (PQ) documents the sterilizer’s ability to achieve the desired outcome (i.e. sterilization of specific loads when operated in accordance with predefined operating procedures).

Factory Acceptance Testing (FAT) is a process used to evaluate the sterilizer after assembly and to verify that its operation complies with design specifications prior to shipment. Through this process all sterilizer components and controls are confirmed. Sterilizer functionality is qualified, verified and documented. Any deviation or abnormalities observed during testing are documented in an exception report and remediated prior to shipment. The FAT is performed at Consolidated’s corporate headquarters before the unit is shipped.

The quality of the steam feeding an autoclave is an important factor in steam steriliza­tion. Like temperature, pressure, and time – steam is a critical variable in the success and repeatability of the sterilization process. As such, steam quality should be part of the validation of any steam sterilizer. Steam quality is defined as the measurable physical aspects of steam used for sterilization. These physical aspects include temperature (superheat), dryness (liquid water content), and non-condens­able gas content. (Steam quality is not a measure of the impurity content of the steam.).

Cycle development is performed to provide you with a sterilization process and recipe that works for your load.  This process will result in parameters (i.e. cycle type, temperature, time, etc.) that can be validated. Ideally, cycle development should begin before the sterilizer is purchased, since the cycle types will affect the type of autoclave you need, and changes in the field after installation are generally difficult and expensive. At the very least, cycles should be developed prior to performing a full validation of the autoclave and, more specifically, before Performance Qualification (PQ) validation.