The Autoclave Qualification Process
Qualifying Your Autoclave
- To ensure that your process continues to provide safe and sterile results, your autoclave must comply with established standards and norms (EN 285 and ISO 17665). In order to successfully do this, autoclaves require periodic qualification and validation to prove that they sterilize within their qualified parameters – and thereby provide completely clean and sterile materials and equipment.
- The requirements for testing your autoclave depends on the country. In Europe, the standardized cycles are 121 °C for 15 minutes or 134 °C for 3 minutes.
In addition to achieving the appropriate temperatures and time periods, there are other critical measurements that you should consider:
- Equilibration Time:
The equilibration time is the time between your first sensor reaching the set temperature and your last sensor to do so – and serves to indicate the homogeneity of your autoclave
- Spread of Temperatures:
The spread of temperatures in your autoclave indicates the distribution of heat within the chamber during sterilization
- Sensor Deviations:
Indicates if your temperature sensors remain within their acceptable range
IQ & OQ Qualifications
The qualification of an autoclave consists of an installation qualification (IQ) and operational qualification (OQ):
- Installation Qualification:This verifies that your system was installed properly – and is typically performed by the system provider
- Operational Qualification:This tests whether your system works as intended or not. To perform an OQ, you need high-end measuring equipment to accurately determine the functionality of your device
Once your autoclave has been proven to work properly, it must also prove that it sterilizes your materials properly too – which is where the validation process comes in
Equipment for Validation and Qualification
Both wireless data loggers and thermocouple systems are a suitable choices when looking for qualification and/or validation equipment for steam sterilization and autoclaves.
- Wireless loggers are, due to the RTD sensor design, very accurate and stable, which makes them the ideal option for both qualifying the autoclave and validating the steam sterilization process.
- A wired thermocouple system can also be used and may initially be the more economical option but will ultimately require far more resources to operate.
When using a wired thermocouple system for autoclave validation, there is the added challenge of maintaining the pressure and vacuum integrity. This is due to the necessity of using a feed-through system to allow the thermocouples into the chamber. Ellab’s feed-through system has been tested rigorously to ensure minimal leakage and optimal qualification efficiency.
Controlling Steam Quality with a Bowie Dick Test
- To ensure properly sterilized products, testing an autoclave’s steam penetration ability is crucial. This requires running a Bowie Dick test program.
- The Bowie Dick test is an important daily routine control conducted on autoclaves. The purpose of which is to ensue proper penetration of steam, to allow it to successfully reach every corner of the chamber, as well as the product. Fully sterilizing it upon contact.
- A Bowie Dick test is, however, only as reliable as the piece of third party equipment gathering the data. Which is why Ellab has developed the Bowie Dick Sensor, a highly innovative solution for electronic Bowie Dick testing