The pharmaceutical industry faces particular challenges when it comes to quality assurance and compliance with regulatory requirements. Above all, the precise monitoring of storage and production conditions is essential to ensure the safety and efficacy of products. This is where the testo Saveris 1 environmental monitoring system, developed in the Black Forest and used worldwide, comes in. But what is behind this technology and how is it used in practice? This article highlights the benefits of testo technology using two exemplary projects with Simon Hegele and Rhenus Logistics, two well-known players in the pharmaceutical and logistics industry.
testo Saveris 1: The backbone of digital quality assurance
The testo Saveris 1 is a sophisticated combination of precise sensor technology and intelligent software that is specially tailored to the requirements of the pharmaceutical industry. It offers a comprehensive, digital answer to the previously widespread paper-based documentation and manual evaluation of measurement data.
Why the digital solution is so important
At the centre of this solution is an audit-proof data management platform that meets the high requirements of the FDA in accordance with 21 CFR Part 11 and Annex 11 of the EU GMP Directive. The testo Saveris 1 fully automates the continuous monitoring and documentation of environmental parameters such as temperature, humidity and differential pressure. One advantage of this solution is the ability not to lose any data even in the event of power failures or connection interruptions, as redundant safety measures are implemented.
Easy integration into existing processes and the ability to visualise measurement data in the form of graphs or tables ensures that companies can not only ensure that they meet all regulatory requirements, but also increase the efficiency and quality of their processes.
Simon Hegele's success story: GDP-compliant deep-freeze storage with Testo Solutions
The project with Simon Hegele is an impressive example of the successful use of Testo technology. The logistics and service provider, which has been in business for over 100 years, needed an innovative solution for the GDP-compliant storage of pharmaceutical products in a new warehouse complex in Karlsruhe.
The aim of the project
For Simon Hegele, compliance with the strict requirements of Good Distribution Practice (GDP) was paramount. These requirements regulate how pharmaceuticals must be stored and transported in order to guarantee their quality and safety. As this was a new field of activity for Simon Hegele, the company was looking for experienced partners. Testo Solutions provided the necessary hardware and software, while Testo Industrial Services provided experts for calibration and qualification.
The challenge and solution
During the conversion of the warehouse, it had to be ensured that the sensitive pharmaceutical products were stored under optimum conditions. The testo Saveris 1 continuously monitored the temperature and humidity values in the warehouse and issued automatic warnings in the event of deviations. This enabled Simon Hegele to maintain the required storage conditions and thus ensure the safety of the products.
The project demonstrates how Simon Hegele and Testo Solutions worked together to develop a customised solution that not only complied with GDP requirements, but also enabled high operational efficiency.
Further information can be found here.
Rhenus Logistics: More than a decade of partnership for drug safety
Another example of the successful collaboration with Testo Solutions is Rhenus Logistics, a global logistics company specializing in the storage and transport of pharmaceuticals. Testo Solutions has been a partner of Rhenus for more than ten years and supports the company in complying with the strict specifications for the storage of pharmaceutical products.
Safety at the highest level
At the Strasbourg site in France, Rhenus has now installed over 250 measuring points in around 150 measuring devices that continuously monitor the temperature and humidity conditions. The Head of Quality Assurance at Rhenus, Patrice Kaps, emphasises the importance of this partnership: ‘We have to keep our products at the right temperature at all times, both during storage and transport.’ Thanks to Testo Solutions, temperature conditions can be monitored and analysed in real time.
Automation meets precision
Testo technology not only enables Rhenus to monitor storage conditions, but also provides a digital quality assurance system with customisable analysis options. This enables the company to recognise weak points at an early stage and take corrective action before problems occur. Here too, the testo Saveris 1 makes an important contribution to ensuring drug safety.
Digitalisation as the key to increasing efficiency and quality assurance
The projects with Simon Hegele and Rhenus Logistics impressively illustrate how digital solutions can revolutionise work in the pharmaceutical and logistics industry. The testo Saveris 1 not only offers companies the opportunity to fulfil regulatory requirements efficiently, but also to proactively control the quality and safety of their products.
Webinar as a source of knowledge
For companies that want to learn more about digitalisation in quality management, Testo offers the opportunity to gain deeper insights in the online webinar. Watch it now!
Conclusion: Future-proof solutions for the pharmaceutical industry
The digital transformation in the field of quality control is no longer a topic for the future - it is a reality. With the testo Saveris 1, Testo offers a comprehensive, practical and proven solution that enables companies to optimise their processes while complying with all regulatory requirements. The success stories of Simon Hegele and Rhenus Logistics impressively demonstrate how companies can not only ensure the quality of their products by using innovative technology, but also sustainably increase their efficiency.
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