Steriliser Validation Services

By combining advanced test instrumentation and technology from EBRO with the assistance of experienced CSSD personnel, sterilisation cycles can be profiled and recorded using wireless temperature and pressure data loggers. Multiple temperature locations and chamber pressure can be monitored simultaneously. The data is transmitted wirelessly to a computer for analysis, allowing the sterilisation cycle and selected load configuration to be assessed and documented.

The validation process considers the applicable load configuration and Product Family, with test results analysed and documented in the validation report.

All sensors used for validation are supported by calibration certificates traceable to an appropriate reference standard.

Wireless EBRO Loggers

The Performance Qualification report includes the following:

• Identification of the steriliser and location
• Heat distribution and temperature measurement results
• Description of the load and loading pattern, including photographs
• Cycle details and relevant process parameters
• Location of sensors and biological indicators, where applicable
• Results of all validation cycles
• Steriliser printouts and relevant documentation
• Investigation of any failed cycle and recommendations, where applicable
• Name and signature of the person undertaking the Performance Qualification
• Calibration certificates for the sensors used

Our steriliser validation services are undertaken with consideration of the applicable requirements of:

AS 5369:2023 – Reprocessing of reusable medical devices and other devices in health and non-health related facilities
ISO 17665:2024 – Sterilisation of health care products – Moist heat

For further information and bookings, please Contact Us today for a quotation.