Process control and monitoring for the pharmaceutical industry

Process monitoring and control in pharmaceuticals are critical to ensuring that the medication and associated applicators are consistent, reliable, and safe. In this article, we take a look at how process control and monitoring is used in the manufacture of medical solutions to ensure that the outputs meet the rigorous standards enforced by the industry bodies that oversee our pharmaceutical processors and see how Baumer UK comes into play.

Process control and monitoring can be split into its two components:

Process control is the usage of industrial control systems in a continuous production process to achieve a level of consistency, economy, and safety that could not be achieved by manual monitoring and control.

Process monitoring relates to distributed computer-based monitoring systems. These facilitate real-time re-configuration of plant controls such as feedback loops and interconnecting sensor stages, plus the added bonus of easy interfacing with other production infrastructure. This provides support in the form of sophisticated warning and alarm systems, automatic event logging, and fine-grained process and equipment status updates providing a single high-level overview of plant status and production levels.

How is process monitoring and control used in the pharmaceutical industry?

Analysing and controlling the manufacturing process through measurements at different stages provides pharmaceutical manufacturers with information around the critical quality and performance attributes of raw and in-process materials, as well as the processes themselves, with the goal of ensuring final product quality. Process monitoring and control can take place at various points in the production process:

• In-line: A sensor is directly interfaced to the process solution.
• On-line: Measurements are made in a secondary recirculation loop.
• At-line: A sample is physically transferred from the process to an analytical instrument in close physical proximity and returns analytical results in a short time cycle.
• Off-line: A sample is removed from the process solution and analysed at a different location and does not return analytical results in a short time cycle.

In-process quality control may be performed at regular intervals during a process (e.g. tabletting or encapsulation) or at the end of a process step (e.g. granulation or blending). The sensors can range from temperature, flow and pressure sensors to varying types of spectroscopy. The tests allow the formulation scientist to identify and follow all changes that may occur during the production process. It gives the security that the finished products fulfil all quality requirements, but most importantly, these steps for process monitoring and control ensure that all the products manufactured are safe for the end-user.

Why is it so important that the pharmaceutical industry uses process monitoring and control?

In the pharmaceutical industry, the ability to guarantee the quality and dosage of a product is paramount. Patient safety must be of the highest concern, and process control and monitoring allow objective and regular checks and feedback of data to ensure that all production processes are within their intended specification parameters.

From the financial standpoint of the manufacturers, the ability to prevent an unmarketable product being created in high volume is also critical; not only would it affect the margins of the pharmaceutical company, but ultimately, if the process control and monitoring facilities are not there to prevent such occurrences, such production errors would impact the supply and cost to the patients.

What does process monitoring and control help to prevent?

The list could be endless but it could range from something as simple as a physically malformed product, through to the worst-case scenario of a contaminated product. With process monitoring and control in place, the product can be checked at every stage of production in multiple ways and any discrepancies can be handled immediately.

An example of where something seemingly simple could go wrong is at the point of heating raw ingredients in a vessel; if the mix requires a set temperature and pressure to ensure no undesirable by-products are produced, but the temperature or pressure were to vary outside of their set parameters, those bi-products could cause issues at a later stage in production or, even worse, contamination of the final product. A simple hygienic temperature sensor and pressure sensor would prevent such an occurrence.

It is clear that process control and monitoring in any manufacturing business is a bonus and prevents unnecessary waste or faulty products being made. In pharmaceuticals, however, process control and monitoring is clearly critical for the safety of the patients for whom the products are intended. Without such close, automated supervision of manufacturing processes, there can be no guarantee of the quality or consistency of the final product – which, in many cases, maybe a life-saving medication.

Process monitoring and control with Baumer

When a high-quality product is required in order to meet the strict demands of the pharma industry, this is when Baumer comes to mind. Baumer offers a wide range of reliable and powerful industrial products, such as cameras, sensor solutions, and a variety of products for the quality and process control of pharmaceutical products. To learn more about Baumer’s range of products, visit www.baumer.com.