The Testo 190 is a state-of-the-art sterilisation data logging technology that supplies support for validation/qualification tasks. The system is capable of measuring and monitoring temperature and pressure. This is often in relation to the sterilisation process. Because of its ingenuity and intuitive design, this tech lends itself perfectly to industry leaders who want complex functionality paired with a simple user interface.
What is the Testo 190?
The Testo 190 is Testo’s premium temperature and pressure logging technology. It is the ideal solution for the biomedical, medical, dental, and pharmaceutical industries. Its intuitive software is CFR Part 11 compliant and boasts industry-leading design innovations. This includes expanding on its sophisticated logging capabilities. This all comes together to create an extremely efficient and effective piece of technology.
The Testo 190 enables your lab to engage in robust sterilisation and validation processes. Whether you’re in a pharmaceutical or biomedical lab, the Testo 190 guarantees accurate data logging/readout results while being simple and easy to maintain. In addition to this, the tool offers full, audit-relevant documentation that is accessible with just the click of a mouse.
Furthermore, the Testo 190 offers optimum functionality with the pressure and temperature measurement process. This is one of the most important sterilisations and validation steps. The clear structure guides users, regardless of their skill level, intuitively through the process step by step. In addition to this, there is no need to export data to Excel or an equivalent spreadsheet program, making it easy to share and analyse.
Another useful function of this tool includes the automatic calculation of the F0 value. This is a measure of the severity of a thermal process with respect to reduction in microorganism (Clostridium botulinum) viability within a particular product. In this scenario, it refers to how severe the thermal process needs to be for sterilisation to be complete.
The Testo 190 CFR software also has the following individual process parameters:
- temperature span
- minimum hold time
- maximum acclimatisation time
- maintain GxP procedures
- supplies reliable audit trails
The software clearly explains these parameters and makes them easy to understand and intuitive to use. The Testo 190 CFR software also enables comprehensive analysis, graphical and tabular display, and evaluation of all recorded measurement data.
This technology seamlessly integrates with your workflow for validation and qualification tasks. From the simultaneous programming and readout of the eight CFR data loggers simultaneously, through to the comprehensive data analysis, audit trail functions and digital signatures, the 21 CFR Part 11 compliant Testo 190 CFR software is extremely intuitive.
Why You Need the Testo 190
Steam under pressure was first developed in 1679 when Denis Papin invented the autoclave. Since then, it has been used reliably as it is an efficient way to destroy microbes. The vapour released as pressurised steam raises the temperature and efficiently kills viruses and germs. Effective autoclave sterilisation requires the steam's temperature to be between 121 and 132 degrees Celsius and typically pressurisation is between 1.5 bar and 4 bar. In such severe conditions, it is crucial to have a high level of confidence in the reliability of the loggers and their accuracy.
Testo 190’s CFR software is trustworthy and intuitive, meaning that there is no need to spend extra time training people on how to use a complex system. In addition, the Testo CFR software allows for a readout of up to 245 loggers in one validation process.
If you’re seeing wet sterilisation bags and materials after a cycle, there is a good chance your autoclave is suffering from poor steam quality. Poor steam quality ruins an efficient workflow, meaning you may potentially need to start the whole process over again. A quick and easy way to validate steam quality is through the use of an accurate autoclave logger that works in tandem with the Testo 190 CFR software.
In 2019, microbial growth made its way into the batches of the antibiotic amikacin sulfate. This is used in the treatment of bacterial meningitis, infected burns, cystic fibrosis and severe UTI infections and schizophrenia drug prochlorperazine desolate. This was due to inadequate sterilisation validation by the US pharmaceutical company Emcure’s Indian laboratory. This is not the only example of an easily preventable error causing widespread harm.
This all could have easily been avoided with a suitably implemented validation logger system. This oversight can not only lead to the hospitalisation of victims, it can even lead to their death.
At the beginning of 2020, a Melbourne lab was the first lab outside of China to replicate the coronavirus. This was done to help contribute to the efforts to create a vaccine. The waste generated from these experiments had great potential to transmit and cross-contaminate during the disposal process. In order to avoid this potential danger, effective autoclaving was necessary to guarantee there was no risk.
The Testo 190 is an innovative and industry-leading technology that eliminates issues before they even have the chance to appear. For more information about the Testo 190m get in contact with the expert team at Testo NZ today