When storing pharmaceuticals, a high degree of compliance awareness is required in order to work safely and in accordance with the standards. This is because the indoor climate in storage rooms has an effect on the efficacy and quality of pharmaceuticals and, thus, on people’s health.
With complete solutions, data loggers and metrological services from Testo, you establish a constant and standard-compliant storage climate:
Comprehensive support by Testo enables you to respond to any deviations in good time and in addition, to reliably comply with regulations covering GSP (Good Storage Practice), GDP (Good Distribution Practice) and 21 CFR Part 11.
Complete solutions (monitoring systems) consisting of sensors, software and services record and document all audit-relevant environmental parameters.
Measurement technology such as data loggers seamlessly records the relevant environmental parameters.
Metrology services such as validation, qualification and mapping ensure that measurement technology is used optimally and that your premises and processes comply with current standards. The documentation is also standard-compliant, so you can look forward to the next audit with confidence.
Safety, reliability and conformity to standards are important in the storage of pharmaceuticals.
Safety: The measurement technology used must ensure that the quality and integrity of the stored products are not compromised.
Reliability: Environmental parameters must be monitored seamlessly - 24 hours a day. And in the event of limit violations, it is mandatory that an alarm be triggered.
Conformity to standards: Both the storage conditions themselves and the solutions used for monitoring must comply with current standards and guidelines.
The two industry-leading monitoring solutions testo Saveris 1 and testo Saveris 2 provide automated and efficient support in complying with your regulatory requirements.
With the fully automated environment monitoring system testo Saveris 1
Download now and find out what’s important in the storage of pharmaceuticals and other temperature-sensitive goods.
Goods and products that are sensitive to temperatures must be manufactured, stored and transported in qualified facilities, with qualified equipment and using validated processes. Here, the three sub-processes of validation, qualification and mapping are of particular importance. Among other things, critical temperature ranges can be identified and specifically monitored to ensure that the safety of the stored pharmaceuticals is not compromised at any time.
Critical temperature ranges in storage
Close to the roller gate
Close to window and skylight
Close to lamps
Distance to the ventilation outlet
Directly at ventilation outlet
Close to door
The purpose of validation is to ensure that a manufacturer's expected results can be guaranteed. A validation process takes place in three steps:
1- Definition of the expected results and acceptance criteria.
2- Verification and documentation that the process delivers the expected result.
3- Determination of continuity, repeatability and accuracy of the validated process.
Testo Industrial Services is your leading service provider for quality assurance and expertise in validation, qualification and mapping.
More service and more security for your company.
Testo Industrial Services supports you in monitoring and ensuring uniform environmental conditions in your warehouse or transport system. From individual temperature distribution measurements or metrological testing to project coordination and conceptual design of complex projects.
For decades, data loggers from Testo have been used all over the world wherever precision, reliability and flexibility are required. What do our data loggers have in common? The different model series cover a wide range of applications. They simply offer you more:
More accuracy: Highly precise from -200 to +1000 °C
More security: Detailed alarm management and measurement data storage even when the battery is empty
More reliability: Seamless recording and documentation of up to 2 million measured values with 8 years battery life
More choice: Extensive probe range in brand quality from series model to custom-made
Testo is also used in laboratories, clean rooms or in production when accurate results and reliable technology are required.