FDA Compliance Customer Story for Pharmaceutical – IRM Enterprises

SolutionsHigh FlexibilitySimple VisibilityStrong ReliabilityImprove abilityImprove operation rateImprove qualityCustomer Story

IRM manufactures tablet presses, capsule filling machines, and granulation equipment for pharmaceutical, nutraceutical, and aligned industries. And have over 40 years, supplied more than 5000 machines in over 60 countries across the globe. IRM manufacturers selected Pro-face based on three criteria. The first reason is versatility. The second reason is reliability. The third reason is the support system.

Background and Challenges

Now pharmaceutical companies are becoming more demanding because they are big and going for regulatory markets like USFDA, UK MHRA, and EU GMP. They want the machines to be 21 CFR Part 11 compliant, which was impossible with the HMI + PLC because this system requires more reliable hardware and software hence the need for IPC (Windows) + SCADA (BLUE Open Studio) + their application.

Solutions - Why choose Pro-face Products-

Versatility

Industrial PC PS6000 Series is 8 generation processor, has a wide range of displays with multi-touch operation, and has many configurable tools. Plus, PS6000 and BLUE Open Studio can develop FDA applications easily, and multiple machines can be integrated into one platform and cloud-supported by multiple drivers of BLUE Open Studio.

Reliability

It gives a very robust terminal, which can handle multi-tasking, take multiple loads, and support the right configuration, a must-required feature for the pharma industry. And all this has helped improve our machine productivity and accuracy.

Support

support is very good. Whenever we have queries, we send them to them, and their response is very fast. So my customers are happy, and I'm happy with them.