When conditions get tough, can your validation equipment keep up?

Sterilisation, freeze-drying, disinfection and pasteurisation all have something important in common: they place measurement equipment under serious stress.

High temperatures, deep vacuum, pressure, steam and significant temperature changes are a daily part of many jobs. Yet these are also processes where reliable measurements and clear documentation are essential to quality assurance.

This creates an interesting challenge. The process needs to be validated, but the data logger doing the measuring must first be capable of reliably operating in the environment it is being asked to monitor.

Testo addresses these requirements with two purpose-built systems: the testo 190 CFR data loggers for pharmaceutical validation and the testo 191 HACCP data loggers for industrial process validation and qualification.

testo 190: designed for pharmaceutical validation

In pharmaceutical and biotechnology environments, validation needs to combine reliable measurement with efficient, traceable documentation.

The testo 190 CFR system is designed for applications including sterilisation, freeze-drying, cleaning and disinfection. Temperature loggers cover a measuring range from −50 to +140 °C, while the testo 190-P1 measures absolute pressure from 1 mbar to 4 bar.

But specifications only tell part of the story.

To investigate how the testo 190 performs over time, Testo subjected the loggers to endurance testing focused on three practical concerns: robustness, accuracy drift and battery reliability.

In one test, the loggers were repeatedly subjected to an overkill steam sterilisation process at 134 °C, including pre-vacuum cycles, steam and vacuum shocks. The testo 190 loggers completed more than 2,000 one-hour sterilisation processes and remained fully functional afterwards.

Freeze-drying presented a different challenge. Loggers were tested at temperatures down to −50 °C and subjected to alternating temperatures between −50 °C and +70 °C. They completed more than 750 hours of testing without failure and remained functional afterwards.

Accuracy was also assessed throughout repeated autoclave cycles. Even after 750 hours of operation, the tested loggers maintained the specified accuracy of ±0.1 °C for temperature and ±20 mbar for pressure.

The system extends beyond the logger itself. The 21 CFR Part 11-compliant testo 190 CFR software supports configuration, analysis and audit-relevant reporting, while the multifunction case allows up to eight loggers to be configured and read out simultaneously.

testo 191: built for industrial processes

While testo 190 is focused on pharmaceutical validation, testo 191 addresses the demands of industrial process validation and qualification.

The HACCP data logger system is designed for applications including sterilisation, freeze-drying and pasteurisation, combining robust stainless-steel housings with hermetically sealed measurement technology.

Its applications extend across food and beverage production, chemical processes, cosmetics, composites and aerospace, electronics and semiconductors, glass and rubber, and wood and construction materials.

In food and beverage production, for example, testo 191 can support the monitoring of pasteurisation and sterilisation processes for products in cans, jars and pouches, as well as the preservation of ready meals, baby food and pet food.

The focus is not simply collecting measurements. Efficient process validation also requires straightforward logger handling, documentation and calculation of relevant parameters. The testo 191 system brings together data loggers, software and practical accessories to support this process.

Different applications, the same demand for reliable data

Pharmaceutical and industrial validation environments have different regulatory requirements and applications, which is why testo 190 and testo 191 are distinct systems.

What connects them is the need to obtain dependable measurement data when operating conditions are anything but ordinary.

Alongside the technology, Testo Australia provides services covering calibration, qualification and validation, with customers also having access to Australian-based support and expertise.

Whether the application involves pharmaceutical freeze-drying, steam sterilisation or industrial pasteurisation, reliable validation starts with measurement technology specifically designed for the harsh conditions in which it will be used.