More "Quality Time" thanks to a monitoring system

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 solutions for heart vessel expansions are produced. Some of the work is done manually by around 190 nurses. The manufacturer’s basis is the compliance with and documentation of the highest hygiene standards in the production areas.

For maintaining strict quality and safety standards, Artivion Inc., Jotec GmbH needed a reliable and modern monitoring system that continuously monitors and documents environmental parameters and particle concentration.

It was particularly important to the customer that the monitoring system could be flexibly adapted to the existing room requirements and process workflows. In this case, to a cleanroom facility for the manufacturing and packaging of medical implants, which must meet the highest quality and safety standards. The system must reliably record and document all relevant parameters such as pressure, temperature, humidity, and particles.

The entire cleanroom facility consists of 22 rooms with different functions. Therefore, the monitoring system had to be adaptable to the various room functions.

An important aspect of the project was the efficient integration of the large number of employees working in different shifts. To quickly direct over 250 employees into the cleanrooms, special airlocks were developed for the work areas.

Before the project could start, an engineering phase was conducted to review the technical implementation, design the climate technology, and plan the installation site of the equipment with maintenance access.

Then, the implementation began. Various equipped BRIEM MEASURE panels were used to measure pressure and temperature in the cleanroom. The panels, with fully integrated measurement technology, are designed for surface-mounted installation in the cleanroom wall. In addition to very convenient calibration options, they are also very easy to clean (Hygienic Design). Additionally, room temperature sensors and laser particle counters with Modbus interface were installed for continuous particle monitoring.

A three-color LED signal light serves as a visual aid to indicate warning and alarm thresholds. It is positioned so that it is visible from any point in the room. Furthermore, an integrated alarm forwarding module ensures that alarms are also forwarded to responsible persons via email or SMS.

All sensor measurement data and control and alarm elements can be accessed efficiently and intuitively via the BRIEM monitoring software. To optimally reflect the customer process, a customer-specific profile switch was implemented in the software. Reports are automatically generated and distributed via templates. Access to the system is via monitoring clients, with login linked to the user's Windows login through Active Directory integration. This system thus provides a comprehensive solution that enables both monitoring and communication of critical conditions in real-time.

Artivion Inc., Jotec GmbH now has a reliable and modern monitoring system that continuously monitors and documents environmental parameters and particle concentration. In the second step, the system was expanded. Through a so-called retrofit solution, the outdated existing system was upgraded. Based on a comprehensive feasibility study, the components of the old system were successfully integrated into the new solution. Thanks to successful collaboration, further projects are already in planning.