The testo 190 is a state-of-the-art sterilisation data logging technology that supplies support for validation/qualification tasks. The system measures and monitors temperature and pressure, often in sterilisation processes. Because of its simplicity and ingenuity, this tech is ideal for industry leaders who want a complex functionality paired with a simple user interface.
What it is
The testo 190 is Testo’s premium temperature and pressure data logging technology that is ideal for the biomedical, medical, dental and pharmaceutical industries. Its intuitive software is CFR Part 11 compliant and boasts industry-leading design innovations, which include expanding its sophisticated logging capabilities. This cumulates to create an extremely efficient and effective piece of technology.
The testo 190 enables your lab to engage in robust sterilisation and validation protocols, whether in a pharmaceutical or biomedical lab, that would guarantee accurate data logging/readout results while being simple and easy to care for. In addition, the tool has full, audit-relevant documentation that is accessible with just the click of a mouse.
The testo 190 also offers optimum functionality with the pressure and temperature measurement process, which is one of the most important sterilisation and validation steps. The clear structure guides users, regardless of skill level, intuitively through the process step by step. There is also no need to export data to Excel, making it easy to share and analyze.
You will find that the technology includes seamless and effective support for your validation and qualification tasks. From the simultaneous programming and readout of up to eight CFR data loggers at the same time, through comprehensive data analysis, to audit trail functions and digital signatures – the 21 CFR Part 11-compliant testo 190 CFR software is extremely intuitive.
Why You need it
Steam under pressure was first developed in 1679 when Denis Papin invented the autoclave, and has been used reliably ever since because it is the most reliable way to destroy microbes. The vapor released as pressurized steam raises the temperature, which kills viruses and germs. Effective autoclave sterilisation requires steam temperatures between 121 and 132 degrees C and typical pressurisation is between 1.5 bar to 4 bar. In such severe conditions, it is important to have a high level of confidence in the reliability of the loggers and their accuracy.
This is where the trustworthy and simple-to-understand testo 190 CFR software comes in handy. Because the software is so easy to use, there is no need to spend extra time training people on how to use a complex system. Additionally, testo CFR software allows for a readout of up to 254 loggers is possible in one validation process.
If you’re seeing wet sterilisation bags and materials after a cycle, your autoclave may be suffering from poor steam quality. Poor steam quality ruins an efficient workflow, and you may need to start the whole process over again. A quick and easy way to validate steam quality is with the use of an accurate autoclave logger that works in tandem with the testo 190 CFR software.
Other useful functions of this tool include 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,” according to the Australian Department of Agriculture, Water, and the Environment. In this case, 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
- lethality
- maintain GxP procedures
- supplies reliable audit trails
The parameters are explained in the software and are easier to understand because of this. At the same time, the testo 190 CFR software enables comprehensive analysis, graphical and tabular display and evaluation of all recorded measurement data.
Situational Examples
In 2019, microbial growth made its way into the batches of the antibiotic amikacin sulfate that is used in the treatment of bacterial meningitis, infected burns, cystic fibrosis and severe UTI infections and schizophrenia drug prochlorperazine disulate due to the inadequate sterilisation validation by US pharmaceutical company Emcure’s Indian laboratory. This is not the only example of an easily preventable error wreaking havoc on victims.
The issues with the microbial growth would have been avoidable with a suitably implemented validation logger system. This tragic mistake could leave victims hospitalised and even, in some cases, dead.
The coronavirus was replicated at the beginning of 2020, the first time outside of China, in a Melbourne lab 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 these dangers, effective autoclaving is necessary to guarantee there is no risk.
The testo 190 is an innovative and industry leading technology that eliminates many issues before they appear.
Buy the incredible testo 190 here!