A monitoring system without clear requirements? In GMP-regulated areas, this can become costly and risky. Learn why a well-thought-out URS is the key to successful projects, secure audits, and long-term compliance.

In regulated environments such as the pharmaceutical industry, biotechnology, clinics…

A properly functioning cleanroom largely depends on the interplay of physical parameters. Especially air change rate and differential pressure influence the purity and safety of the environment – and should therefore not be considered in isolation during planning and operation, but understood holi…

Retrofit projects offer an excellent opportunity to modernize existing monitoring systems in the GxP-regulated environment economically and future-proof. However, several key aspects must be carefully examined in advance.

Monitoring systems in the GxP environment play a central role in monitoring qua…

The adherence to strict cleanroom conditions is of great importance in numerous industries, especially in the pharmaceutical, biotechnology, and medical technology sectors. Good Manufacturing Practice (GMP) requires continuous monitoring of particle concentration in the air to ensure product quality…

This project involved a comprehensive upgrade of a monitoring system responsible for overseeing critical environmental parameters such as pressure and humidity. The renewal included the installation of modern particle sensors and the updating of the associated software to enable precise data collect…

For the compliance with quality standards in the pharmaceutical production of BA. Manufacturing, an existing monitoring system was optimized and brought up to date with a retrofit project. Existing sensors were integrated, and the system was transitioned during ongoing operation.

BA. Manufacturing sp…

What does a Unit Dose area mean for a GMP monitoring system, which parameters should be monitored, and what should be considered when using packaging systems?

Modern medication supply systems are capable of assembling, packaging, and labeling medications tailored to individual patients. This support…

As a steadily growing, internationally active manufacturer of high-quality vascular implants/stent prostheses, Artivion Inc., Jotec GmbH supports surgeons in saving lives. In the approximately 1500 sqm cleanroom facility at the newly built site in Hechingen (Baden-Württemberg), patient-specific sol…

When operating a GMP monitoring system, the question often arises whether a hardware server or a virtual server is the better solution. We have examined both options in detail and compared their advantages and disadvantages.

GxP-compliant monitoring systems are important monitoring and analysis tools…

For the new construction of the pharmacy at the University Hospital of Saarland, a cleanroom monitoring system was required in the GMP manufacturing area as well as for the unit-dose area to monitor environmental and process parameters. Additionally, temperature mapping was needed for several storag…