Pioneering Next-Generation Process Control in Pharmaceutical Manufacturing

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Challenge

AGC Pharma Chemicals, a global CDMO specializing in small molecule APIs and intermediates, faced a critical strategic decision at their Spanish facility. While their existing process control system was functional, they recognized the need to future-proof their operations with web-based DCS technology.

However, implementing PCS neo in a pharmaceutical environment presented unprecedented challenges –, as there was not known any other reference in the pharma industry with PCS neo. Given the stringent regulatory requirements for validated pharmaceutical manufacturing systems and API production's mission-critical nature, the stakes were exceptionally high.

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Solution

AG Solution engineered a comprehensive implementation strategy beyond standard DCS deployment. Our team:

• Developed a pioneering validation framework for PCS neo in pharmaceutical applications, addressing GAMP 5 and regulatory requirements.
• Conducted extensive gap analysis between traditional pharmaceutical DCS requirements and PCS neo's capabilities, collaborating directly with Siemens to ensure all GMP-critical functionalities were adequately addressed. This included electronic records management, audit trail requirements, and system security features essential for pharmaceutical operations.
• Developed a specialized training program for our automation engineers that combines PCS neo technical expertise with the requirements of the pharmaceutical industry, ensuring that both technological and regulatory needs are addressed throughout the implementation.

Results

The successful implementation delivered several groundbreaking outcomes:

• Established one of the world's first validated PCS neo installation in a pharmaceutical facility, meeting all regulatory requirements for the new laboratory launch
• Created a comprehensive framework for future pharmaceutical PCS neo implementations, including detailed validation protocols and pharmaceutical-specific system requirements
• Provided Siemens with actionable insights for enhancing PCS neo's pharmaceutical industry capabilities, directly influencing the platform's development roadmap
• Enabled AGC Pharma to leverage advanced features like native web visualization, improved system diagnostics, and enhanced data integration capabilities while maintaining GMP compliance

This pioneering project modernized AGC Pharma's control systems and established a blueprint for pharmaceutical companies looking to transition to next-generation DCS platforms.