Visualisation solution for regulatory compliance and effective data management

By Staff Report April 9, 2025 12:34 pm IST

NKP Pharma partnered with Rockwell Automation to overcome regulatory and data access challenges by implementing FactoryTalk® Optix™, a modern HMI solution. This case study shows how the transformation enabled cost-effective 21 CFR Part 11 compliance and enhanced customer satisfaction through improved data accessibility and performance.

———————————————————————

NKP Pharma, a pharmaceutical machinery manufacturer, is committed to innovation and delivering advanced solutions that meet the evolving demands of the pharmaceutical industry. Established in 1988, NKP launched its first automatic machine for sterile dry powder injectable filling. Today, NKP Pharma is a significant player in India’s pharmaceutical packaging machinery sector.

Challenges faced by NKP Pharma:
NKP faced a significant challenge navigating the pharmaceutical industry’s stringent regulations, particularly compliance with USFDA 21 CFR Part 11. These regulations govern electronic records and signatures, protecting data integrity and traceability in pharmaceutical manufacturing.

Traditional IPC-SCADA systems, designed to achieve 21 CFR Part 11 compliance, had become cost-prohibitive. For NKP Pharma, implementing the IPC-SCADA solution across all their machines strained budgets and passed on high costs to customers. Additionally, the current setup centralised data management with NKP Pharma, leaving customers without direct access to their operational data. This lack of accessibility created a hurdle for customer satisfaction and operational efficiency.

Solutions offered by Rockwell Automation:
NKP sought a cost-effective solution that supported compliance with 21 CFT Part 11 while granting customers access to more of their data. Turning to Rockwell Automation, NKP Pharma looked to modernise its systems without compromising quality or compliance.

Rockwell Automation recommended FactoryTalk® Optix™, a next-generation HMI solution for advanced visualisation and seamless data integration. FactoryTalk® Optix™ simplifies automation and enables real-time insights into machine operations. Its flexibility and user-centric design make it an ideal choice for pharmaceutical manufacturing environments requiring regulatory compliance and robust data management.

NKP Pharma initiated a pilot project to test the solution on their inspection machine. As part of the implementation, the company included 21 CFR Part 11 criteria, such as user-level access control, alarm reporting, and online reporting. This structured experiment with FactoryTalk® Optix™ allowed NKP Pharma to reap the benefits of modernising their system before deploying it onto other machines on their floor and customer machines.

Results achieved:
The pilot project FactoryTalk® Optix™ delivered impressive results. The new HMI solution met compliance requirements while reducing expenses.

“I can proudly say that after implementing FactoryTalk® Optix™ during our pilot phase, we have the cost-effective solution for the market concerning the costly solution of IPC-SCADA,” said Alpesh Mistry, Vice President of Operations, NKP Pharma.

Following the pilot project’s success, NKP Pharma successfully implemented the FactoryTalk® Optix™ on customer machines. Customers appreciated the improved accessibility and performance, leading to increased orders for machines equipped with the new HMI solution.

The company now plans to integrate FactoryTalk® Optix™ into their filling line machinery and diversify their portfolio with advanced injectable pharma solutions, such as blow-fill-seal machines and cartridge-filling machines.