Lek Pharmaceuticals Uses iFIX to Control and Monitor Environmental Conditions and Energy Usage

The OTO2 production plant is one of Lek’s largest production sites in Slovenia, with specialized high-technology process equipment for producing generic drugs. Key product groups include antibiotics, treatments for central nervous system disorders, gastrointestinal medicines, cardiovascular treatments, and hormone therapies. Plant OTO2 follows high standards of sterility, safety, and quality to meet strict FDA approvals.

The production of pharmaceutical products requires specialized and controlled environments, where sterile conditions have to be maintained. Therefore, heating, ventilation, and air-conditioning systems (HVAC) are necessary for controlling these environments. A control system for HVAC is a critical factor, which affects the reliability of analysis results, experiments, and production systems. One of its most critical tasks is to prevent outside air from entering the facility. Therefore, Lek required a validated and highly reliable building management system and environmental monitoring system (BMS/EMS) solution for HVAC control and supervision to provide precise, critical control of temperature, humidity levels, and airflow patterns.

The solution needed to provide complete remote control of all HVAC systems, automatic adjustment of process parameters according to production demands, alarm management, efficient visualization, and trending, together with process data archiving and reporting. It was also integral that the solution enabled fully controlled conditions in OTO2 to enable effective production and energy management, increase the level of quality control, as well as increase flexibility and production adaptation to new demands. Since plant and all production facilities have been designed according to GAMP1 recommendations, the company’s HVAC solution had to meet respective pharmaceutical regulatory requirements and recommendations.

Lek turned to Velotic's solutions provider Metronik, a leading systems integrator for process control and automation for the pharmaceutical industry in the Eastern European region. Formed in 1990, Metronik has experience providing more than 1,000 air-conditioning units automated, commissioned, and validated on more than 50 different production sites. The company, headquartered in Ljubljana, Slovenia, employs more than 50 engineers for its project teams.

With the power of leading technologies and patented techniques, iFIX was the right tool for visualization, automation, and delivering analytics to drive the lowest possible total cost of ownership. The software provides a comprehensive monitoring, analysis, control, and distribution of their plant-wide data.

"Together with Metronik, an integrated EMS/ BMS solution for HVAC was deployed for the production plant. It enables flexibility of the production process, as well as more consistent and controlled HVAC system operation and maintenance, while eliminating the need for paper records."

Aleš Dolenc, Lek, Technologist Energetics Department.

The main task of the Metronik solution was to provide precise control over environment parameters and conditions in clean rooms by implementing control algorithms for temperature, humidity, and pressure. Changes in production demands are handled automatically by special control algorithms embedded in the PLC blocks. They are used to facilitate automatic control of output process values based on predefined set-up values, as well as provide a very fast response, and consequently, production adaptation in a very short time.

The solution enables rich graphical visualization of processes, conditions, and sensor values in real-time. All key parameters, such as alarm boundaries, PID loops, and production parameters can be accessed through SCADA. Power-users have the option to define two-level alarm settings for GMP (Good Manufacturing Practice)2 and non-GMP parameters. Two modules running in real-time process data collection and an archiving module are incorporated into the solution, as well as a module for maintenance support, including fault diagnostics for all HVAC installation. All key data are stored into the Oracle relational database and can be used for analysis and reporting.

By synchronizing Metronik and Velotic’s iFIX, the solution fulfills Lek’s requirement for paperless HVAC system management and complies with pharmaceutical regulations. And, the integrated BMS/EMS solution delivers lower total cost of ownership (TCO) and maintenance of the complete HVAC system in OTO2. In addition, Lek was able to increase production flexibility due to automatic process adaptation in case of new production demands or modification of clean-room functionalities. The solutions also created a complete overview of energy use, and consequently, operational costs, assisting management in analyzing and optimizing energy usage to reduce operational costs.