Introduction to Alcon and Their Production Process
Alcon, a global pharmaceutical vision-care manufacturing and research company with a rich history dating back to 1947, has established itself as a leader in the eye care field. With over 10,000 employees and multinational production facilities, Alcon's Belgium division focuses on producing specialized eye care products with strict automation requirements. The pharmaceutical industry demands adherence to stringent regulations, including the electronic process tracking defined by 21 CFR Part 11.
Compliance with FDA Regulations
The implementation of 21 CFR Part 11 regulations requires a structured approach, which Alcon has embraced through an object-oriented control layer strategy. By organizing standard building blocks in the programmable logic controller (PLC), every sensor value undergoes calibration, alarm boundary checks, and calculations before reaching its final state. Changes to set points and calibrations are restricted to authorized personnel, ensuring compliance with the regulations and guaranteeing data integrity.
Enhanced Data Monitoring and Reporting
Alcon utilizes the Proficy Historian product from GE Digital Plant Applications to capture historical process values and store them securely. This high-performance data historian, compliant with 21 CFR Part 11, enables Alcon to analyze trends and generate reports for quality assurance and production purposes. The adoption of Proficy Historian has significantly improved response times, minimizing the impact on existing systems while offering efficient storage capabilities.
Optimizing Production Processes
In their quest for continuous improvement, Alcon has leveraged GE Digital Plant Applications' solutions to optimize their production processes. By integrating security features within the SCADA system and Microsoft Windows®, Alcon ensures seamless authorization and compliance throughout the system. The structured network infrastructure, divided into administrative, production, and validated application networks, further enhances monitoring of environmental conditions and equipment status.