Building management and environmental monitoring with zenon

Facilities in industries like aseptic manufacturing of pharmaceutical medicinal products need control (BMS) and monitoring (EMS) solutions. Questions about system validation always arise. Critical steps require GMP according to regulatory compliance and validation, so an EMS is authenticated based on system design meeting the system’s functionality, which must be documented in a User Requirement Specification (URS).

With the zenon Software Platform, a modular, open, scalable and highly available solution, the need for validating disparate platforms is reduced.

The environment in which your product is manufactured directly impacts product quality. Monitoring and controlling the critical environmental conditions helps to ensure quality and compliance.

All GMP relevant parameters like temperature, pressure and particle counter can be easily monitored, controlled and recorded. Upon request, exception reports can be easily created to support the quality assurance (QA) department during batch review or in case of inspections.

Thanks to the various native drivers and industry protocols in zenon (such as OPC UA or BACnet), complex systems or existing equipment can easily be connected – even if the existing auxiliary systems are composed of many different technologies or generations.

It allows you to keep track of the entire system and helps detect and understand interactions between the individual system parts. Its modular design and scalability support existing configurations, increase functionality, ensure hardware independence and ultimately provide better results. The data can be easily shared between different systems in order to provide GMP relevant environmental information to other systems like line execution or batch control.

zenon's alarm administration ensures that the operators in charge are immediately informed about alarms and can respond to problems as quickly as possible. Escalation of alerts and warnings ensures someone is eventually advised of the situation if a lower level first responder does not remedy the issue.

If there are irregularities in building management – such as a drop in differential pressure or differing temperatures – alarms are immediately generated, pre-filtered and the result is sent via e-mail or SMS to the employee in charge that is working in the current shift. A dashboard view of the plant additionally supports immediate response and uses the analysis to rectify errors or, if necessary, improve the configuration in building management.

Every area or individual process in the production company requires individually created parameters, whether they are for functionality, monitoring or data archiving. Because of this, equipment such as clean rooms are often not included in the monitoring and production's building management.

With zenon, you can integrate all areas into a clear, fully regulated, complete system. It includes audit trail, test logs, alarms, recording of GMP relevant data, user authorization, data export, reports, redundancy and much more. The result: an improved presentation and analysis, a deeper understanding of the processes and the possibility of optimizing procedures throughout the entire factory.

Real-time monitoring of every environment is provided by one system, and live data of each room eliminates the need to walk around and manually test and measure. Analytics of the rooms and the effectiveness and possible issues of the facility such as HVAC are also provided.

Energy consumption in pharmaceutical manufacturing presents an enormous potential for savings that is often not implemented. zenon can also be used as an Energy Data Management System (EDMS). With zenon as an energy data management system, you fulfill the requirements of ISO 50001 and not only analyze consumption data with respect to past consumption, but do so in real time. You can compare the energy consumption of buildings and auxiliary equipment with the data from production and check the energy efficiency of the processes. By doing so, you detect any potential for savings and decrease costs.

Pharmaceutical manufacturers in particular need to meet strict requirements and are subject to a painstaking documentation and supervision obligation. This also relates to clean rooms or other rooms that, for example, must have a certain temperature, air humidity or amount of allowed air particles.

zenon makes efficient compliance possible. For instance, applications with zenon meet international regulations such as FDA 21 Part 11 or EU Annex 11. Furthermore, zenon is configurable and therefore meets the requirements of GAMP 5 Software Category 4.

Configurable systems are very robust, increase process quality and reduce the risk of errors, which makes standards-compliant validation and qualification of the automation systems as easy and efficient as possible and cuts costs and effort. Data integrity compliance can be easily obtained with out of the box and configurable functionality like user management, electronic signature, audit trail, historian, reporting with deviation detection and more.