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NKP Pharma is a leader in pharmaceutical machinery manufacturing, committed to innovation and delivering advanced solutions that meet the evolving demands of the pharmaceutical industry.
- Find a cost-effective solution to maintain 21 CFR Part 11 compliance.
- Provide customers with more access to their data.
- Reduced costs compared to IPC-SCADA systems and improved 21 CFR Part 11 compliance for both NKP Pharma and its customers
- Enhanced visualization, batch data management, and customer satisfaction
- Expanded NKP Pharma market presence with plans for automated injectable pharma machinery
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Challenge
Industry-Wide Need for Better Pharmaceutical Compliance Solution
NKP Pharma is a leading manufacturer and exporter of pharmaceutical machinery in India and is becoming a trusted name globally. A Rockwell Automation gold-level OEM for more than 20 years, NKP Pharma has excelled in integrating automation and partner products into their machines. However, the company faced a significant challenge: navigating the stringent regulations of the pharmaceutical industry, 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 of their machines strained budgets and passed on high costs to customers. Additionally, the current setup centralized 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.
To address these challenges, NKP sought a cost-effective solution that supported compliance with 21 CFR Part 11 while granting customers access to more of their own data. Turning to Rockwell Automation, NKP Pharma looked to modernize their systems without compromising quality or compliance.
Solution
Testing FactoryTalk® Optix™ for Pharmaceutical Compliance
Rockwell Automation recommended FactoryTalk® Optix™, a next-generation HMI solution designed for advanced visualization 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 from modernizing their system before deploying it onto other machines on their floor and on customer machines.
Result
Pharmaceutical Compliance Success for Company, Customers, and Beyond
The pilot project with FactoryTalk® Optix™ delivered impressive results. As Alpesh Mistry, Vice President of Operations, says, “I can proudly say that after implementing FactoryTalk® Optix™ during our pilot phase, we have the cost-effective solution for the market with respect to the costly solution of IPC-SCADA.” In other words, the new HMI solution met compliance requirements while reducing expenses—the exact objective NKP Pharma wanted to achieve.
NKP Pharma then began to use FactoryTalk® Optix™ on customer machines with great success. Customers appreciated the improved accessibility and performance, leading to increased orders for machines equipped with the new HMI solution.
The adoption of FactoryTalk® Optix™ has solidified NKP Pharma’s reputation as a leader in the pharmaceutical packaging industry in India, and that reputation is growing steadily around the world.
What else does the future hold for NKP Pharma? The company 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.
By investing in automation, infrastructure and research, NKP Pharma is poised to maintain its leadership in the pharmaceutical machinery sector, delivering cutting-edge solutions that meet global market demands.
Published April 4, 2025