Retrofit – Monitoring system for pharmaceutical manufacturing

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 specializes in the production and trade of highly sensitive, often patient-specific medications. With a broad range that includes cytostatics, ophthalmics, and parenteral nutrition, the company covers important areas of medical care. As a wholesaler and homecare service provider, BA. Manufacturing also supports outpatient patient care, contributing to the improvement of healthcare services.

The project aimed to improve monitoring in the critical areas of cytostatic production and parenteral nutrition. It involved integrating existing sensors into a new system during ongoing operation and monitoring 34 cleanrooms, with particular focus on 4 manufacturing rooms in the PE area and 3 production rooms in the Cyto area. The rooms correspond to cleanroom classes D to A. Additionally, storage areas and cooling devices were connected, and an existing alarm system was integrated.

Careful planning and collaboration with the customer were crucial for the successful integration and transition of the existing sensors during ongoing operation. A comprehensive feasibility study considered all technical and logistical aspects, and interfaces were precisely defined. In addition to the existing sensors, 26 pressure sensors, 9 temperature sensors, 4 humidity sensors, and 17 particle concentration sensors at safety workbenches were installed and connected to the monitoring system to monitor environmental parameters. For monitoring particle concentrations in Class B rooms, 9 particle counters with external pumps were used. The tubing lengths at the measurement points were limited to a maximum of one meter according to Annex 1 guidelines.

The temperature monitoring of refrigerators and freezers located at various sites is carried out via PT1000 sensors; incubators are monitored via the existing line with BRIEM Ethernet sensors. The existing alarm system was successfully integrated, and some sensors were replaced for improved measurement accuracy.

All sensor measurement data and control and alarm elements can be accessed efficiently and intuitively via the BRIEM monitoring software. Alarm forwarding is handled via the alarm forwarding module, which sends alerts via email and SMS.

Before system delivery, it was fully tested together with the customer as part of the FAT test at the plant in Nürtingen. The entire monitoring system was qualified by BRIEM qualification engineers according to GMP, and all sensors were calibrated on-site.

This monitoring retrofit project required the full flexibility of an advanced cleanroom monitoring system. Existing sensors had to be integrated into the system, which was then transitioned during ongoing operation. The system now enhances the safety and quality of pharmaceutical products and optimizes the monitoring of critical production processes. The introduction of alarm systems and the update of sensor technology have contributed to reliable monitoring, enabling efficient and compliant production and ensuring adherence to quality standards.