How Optimized Are Your Pharmaceutical Operations?

By Martin Dittmer, Product Manager, Rockwell Automation

One of the most valuable aspects of INTERPHEX is its global nature – the convergence of pharmaceutical professionals from different countries, languages and cultures.

This mimics the convergence of regulatory burdens in the pharmaceutical industry. Regulatory quality, safety and reporting requirements are growing increasingly universal, due in large part to more globalized production. While such requirements are necessary to ensure consumer health, it certainly presents challenges from a production standpoint. Operating efficiently and getting products to market quickly simply isn’t easy under a mountain of paperwork.

The introduction of electronic batch record (EBR) technology has helped ease some regulatory challenges. From building recipes to validating production processes and qualifying batches, EBR systems replace paper-based work flows with computer-based work flows to help reduce human error and speed up processes.

But modern EBR systems move far beyond older “paper on glass” capabilities, which offer little more than an electronic version of paper-based checklists. PharmaSuite software from Rockwell Automation offers a dynamic EBR, offered as part of a manufacturing execution system (MES) suite. Integrated into The Connected Enterprise, this system can collect enterprise recipe and order information, deliver role-based instructions to workers, and provide real-time exception-based reporting during production. Not only does this help reduce compliance costs and speed your time-to-market, but it has helped a number of producers realize fast time to results for every user and optimize production to boost productivity.

Instead of continually sending workers to a work list throughout the day, an MES system that offers a modern, dynamic EBR can help manage and direct and enforce the work flow for every contributor. The system can send unique role-based instructions to each person, whether that’s a dispensing operator weighing ingredients or a forklift driver delivering materials to the packaging line. Whatever the case, the system ensures the recipe always is followed according to its specification.

A modern system can also deliver and capture real-time information for workers. For example, a temperature-gauge reading is often important for compliance and/or quality. Gauge data can be acquired automatically as opposed to a worker walking to the gauge and manually writing down the reading. This can make processes more efficient and reduce the risk of human error.

To further optimize production, a system that takes advantage of The Connected Enterprise can take advantage of new enabling technologies, such as mobile devices, to provide information in more convenient and relevant ways. So while workers who operate at or near a workstation can receive information via PC, others who may spend more time walking the plant floor can receive information on a tablet or smartphone.

Such modern systems and capabilities certainly offer numerous benefits to large, multinational pharmaceutical producers in terms of getting products to market faster, producing more batches, and becoming more efficient across several production sites. They also hold potential for helping small and midrange producers break into new markets by providing a robust platform for managing their work flows and easing regulatory compliance and audits.

It’s also important to note that EBR and MES software systems do not have to be rigid or require custom code changes to meet specific production needs of each producer, facility or line. An advanced software solution does not have to be difficult and expensive to maintain or upgrade.

An MES with an open-content architecture gives users the ability to make changes without impacting the system’s core. Liken this to a smartphone that gives you a base operating system but also allows you to download apps and change your settings. The result is a more configurable and easily upgradeable system. PharmaSuite software takes just this approach.

If this all sounds intriguing, make a point to stop by the Rockwell Automation Learning Center at INTERPHEX. See how our innovative EBR and MES systems are helping automate work flow and production processes today. We will be located at Booth CP-3, next to the registration counter. If you’re not in New York for INTERPHEX, join in on the conversation on Facebook or Twitter.


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Official blog of: INTERPHEX New York -
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