Solutions for the pharmaceutical industry
The zenon software platform enables efficient processes in pharmaceutical manufacturing, regardless of whether mass production or small batches are involved. zenon guarantees transparency and supports you from HMI projects to continuous improvement processes in a validated environment. With zenon software, you get solutions for the following areas:
Monitoring environmental parameters in pharmaceutical manufacturing
With zenon as an Environmental Monitoring System (EMS), Building Management System (BMS) or Water for Injections (WFI), clean room data, heating, cooling, lighting, ventilation, fire protection, energy supply and security systems can be monitored and controlled.
Continuous Pharmaceutical Manufacturing
zenon enables user-friendly and comprehensive process automation for continuous manufacturing:
- Seamless integration with PAT, MVDA and automation systems
- Archive server, recipe management and batches are easy to configure and use
- Comprehensive reporting including batch reports, statistical process control, OEE, etc.
- Exchange real-time and archive data with MES & ERP.
- Preconfigured and customisable functions and services in zenon as GAMP5 software category 4 reduce validation effort
Batch Control according to ISA-88
In addition to FDA 21 CFR Part 11, zenon also complies with the requirements of ISA-88 with zenon Batch Control and separates the process from the operating level.
Since compliance is ensured exclusively through configuration without programming, zenon also meets the requirements of ISPE GAMP5, software category 4.
Recipes can be created and adapted intuitively and without programming knowledge via the graphical user interface. You can choose between a simplified ‘Matrix’ editing mode or the more feature-rich Procedure Function Chart (PFC).
Through complete integration of the batch process in zenon, production data is recorded and analysed simultaneously. This means that the reports required for batch release are available immediately after the process is completed.
Vertical integration in pharmaceutical manufacturing
The zenon Automation Integration Layer AIL enables your company to:
- Cyber-secure connections through encryption of your production data.
- Unrestricted Active Directory support for a secure data access level.
- Centralised electronic data such as GMP-relevant process variables, alarms and audit trails.
- Certified OPC UA servers or syslog servers for easy data exchange.
- Compliance with data integrity regulations, even with older machines.
- Efficient validation through integrated documentation and project comparison wizard.
Human-machine interface HMI for the pharmaceutical industry
- Compliance with data integrity requirements through e-signatures, audit trails, user management, etc. Vertical integration with over 300 different hardware protocols and OPC UA server.
- Paperless and digital system thanks to electronic data recording.
- Fast batch release through integrated batch protocols Security through regular updates and a clearly defined lifecycle
Fast and paperless reporting
zenon records pharmaceutical process data in electronic form so that it is available in real time. Immediately after completing the batch, the operator has a report with quality documentation on their tablet.
Unlike paper-based documentation, zenon automatically detects incomplete, missing or incorrect entries and can prevent human errors.
The electronic data acquisition application guides users through each process step and only continues to the next step when the information is complete and the figures entered are within the defined tolerances.
Advantages of zenon as a line management system
- Compliance with all applicable regulations, such as FDA 21 CFR Part 11
- Elimination of data silos through centralised recording of different machines
- Adaptation to international requirements, as zenon ‘speaks’ eight languages li>
- Transparency of the entire production line in every phase thanks to zenon Batch Control
- Less time spent on batch testing thanks to zenon Batch Report
- Integration of IT and support for hybrid scenarios and networking
- Improved data security through compliance with IEC 62443
Module Type Package (MTP)
In the chemical and pharmaceutical industries, product life cycles are becoming shorter and shorter.
Module Type Package (MTP) is a manufacturing concept that enables shorter product and innovation cycles.
In contrast to conventionally designed process plants, the overall process is divided into small parts that can be easily orchestrated.
The zenon MTP Suite is the solution that allows all systems to communicate with each other in a central control system. Even heterogeneous hardware and software landscapes are no obstacle.
