Proper sterilization is a critical part of any medical or laboratory setting. At our company, we understand the importance of following recognized standards when it comes to validating and calibrating equipment. One of the key standards in this area is ISO 17665, which provides comprehensive guidance on the validation of moist heat sterilization processes. We prioritize adherence to these guidelines to ensure the safety and reliability of our sterilization procedures. By validating and calibrating our autoclave steam sterilizer according to ISO 17665, we can guarantee that all instruments are thoroughly sterilized and safe for clinical use.
Understanding the Validation Process
The first step in ensuring proper sterilization is to carry out a detailed validation of the autoclave steam sterilizer. We begin by establishing a qualification protocol that includes installation, operational, and performance qualifications. During installation qualification, we verify that the unit is correctly installed according to manufacturer specifications. Operational qualification involves testing the machine under normal operating conditions to ensure it functions as expected. Finally, performance qualification focuses on the actual sterilization cycle, confirming that the system consistently achieves the required temperature, pressure, and exposure time. This structured approach allows us to identify any inconsistencies and make adjustments before routine use.
Calibration According to ISO 17665
After validation, ongoing calibration is essential to maintain accuracy. We follow ISO 17665 recommendations by routinely monitoring temperature and pressure sensors and ensuring they are within acceptable tolerances. Calibration involves using certified reference instruments to compare readings and adjust the autoclave steam sterilizer as necessary. We document all measurements and corrections carefully, creating a clear record of compliance. By performing these calibration activities at regular intervals, we not only maintain the efficacy of our sterilization processes but also ensure compliance with international safety standards.
WEGO Medical Solutions for Reliable Sterilization
Our company provides a range of sterilizers designed to meet ISO 17665 requirements. Specifically, the vertical sliding autoclave steam sterilizer we offer is built with precision controls for temperature and pressure monitoring. We have tested our system extensively to ensure that it meets operational and performance criteria, making it a reliable choice for healthcare facilities. By integrating validated calibration procedures with our equipment, we can confidently support safe and effective sterilization cycles every time.
Conclusion
In our experience, following ISO 17665 guidelines for validation and calibration is crucial for maintaining consistent sterilization quality. At WEGO Medical, we combine rigorous compliance with user-friendly design, ensuring that our autoclave steam sterilizer performs reliably under demanding conditions. By prioritizing proper validation and calibration, we help healthcare professionals achieve safe, effective sterilization while maintaining confidence in their equipment.
