Engineers, researchers and others are continually interested in improving pharmaceutical manufacturing equipment in a way that could forever change how people work. What are some examples of recent progress that have been particularly promising and inspiring? By Emily Newton, revolutionized.com
1. Linking Electronic Batch Records With Distributed Control Systems
Thoughtful integration decisions can dramatically improve the design of pharmaceutical manufacturing equipment. Multiple systems can often combine rather than having a sprawling layout that could slow workflows or be more challenging to monitor.
One compelling example comes from factories that design distributed control systems to link with electronic batch record creators. Batch records document the complete manufacturing process, and traditionally, pharmaceutical plants have created them manually. However, this is a highly labour-intensive process.
Some plants have transitioned to electronic batch records. That is a good step, but it is an even better solution when those involved in this process can design the equipment to link distributed control systems (DCSs) with the platforms that make the digital batch records.
That was the decision made at AGC Pharma Chemicals. Previously, the paper batch records required a 150-person team, emphasising the reasoning for a significant process change.
The plant’s leaders went beyond merely moving to an electronic system and designed one that integrated the electronic batch record platform with the facility’s DCS. That component manipulates all the equipment, collecting massive amounts of production data during a typical workday. Since the DCS gathers details about everything from agitator speeds to pressure, much of the data is relevant to the electronic batch records.
The batch records system could directly pull information from the distributed control system, greatly reducing the time required to populate the mandated details. Additionally, this equipment synchronisation reduced manual work, minimising errors. The plant’s leaders plan to roll out the electronic batch records gradually, prioritising them for the products with the highest manufacturing volumes but eventually digitising all commercial efforts.
2. Designing According to an Obsolescence Management Plan
Many producers face supply chain difficulties, necessitating that executives remain agile and able to respond to those challenges as effectively as possible. One way to apply that principle to designing pharmaceutical manufacturing equipment is to consider the individual components and incorporate that data into an obsolescence management plan.
People must design all pharmaceutical equipment aspects — down to the individual fasteners and bearings — by choosing components that will withstand harsh chemicals and demanding environments. Estimates suggest 50 million of the 10 billion bearings made annually become unusable because they get damaged. This is often from the destructive combination of high temperatures, high pressures and corrosive chemicals in pharmaceutical plants and similar industrial facilities.
Purchasing professionals can and should choose bearings made from materials that resist chemical degradation. Some of these options have additional coatings that further extend their service lives, making them ideal for demanding settings. However, supply chain issues can still arise because products eventually become obsolete. The key is to design equipment to reduce those effects.
The first step is to perform a complete audit of the system or equipment. Refer to life expectancy data from the manufacturer, and then break it down more granularly to consider the particular stage of each part. Then, staff must identify the most critical things they may eventually need to replace, such as fans or motors. Has it historically been easy or difficult to order replacements? This information becomes the foundation of an obsolescence management plan.
A related concept known as Design for Manufacturing centers on integrating design decisions with supply chain functionality as early as possible. Designers following this approach may create products with interchangeable components, giving users more flexibility when shortages occur.
3. Choosing Modular Design for Better Versatility
Modular design has become popular for those who want to shorten the construction time frames for essential buildings such as hospitals or schools. However, it has also disrupted pharmaceutical manufacturing equipment by providing users with more flexibility and allowing them to respond to changing needs quickly.
When executives want to scale their manufacturing footprint, they can often simply contact a vendor specialising in modular design and have their aspirations realised in just weeks. This is often highly preferable to traditional expansion methods, which can take years to complete.
One strong example of the possibilities comes from a modular approach devised by a student team that emerged as runners-up in a design competition. A key part of their method involved integrating material delivery machines with building modules. They believed this strategy would reduce the equipment necessary and simultaneously shrink the number of pharmaceutical manufacturing plants required to meet a brand’s goals.
The students called their innovation CAPSULE, partially because it arrives in a 6-metre high-cube shipping container for easy portability to the manufacturing site. Additionally, this modular design is eco-conscious, minimising the environmental footprint while maintaining high manufacturing productivity. More specifically, the containers fold out to form a pharmaceutical lab, complete with an HVAC system already installed. Users can then connect as many as required based on their size requirements.
This design also features a built-in aseptic hatch system that smoothly transfers single-use items from the supply area to a top-of-the-line clean room. Another design decision involves pharmaceutical equipment built into the modules’ walls to save space while maintaining a consistent layout leaders can easily expand to meet emerging needs.
Breaking New Ground in Pharmaceutical Manufacturing Equipment
These fascinating examples show how decision-makers have virtually endless options when determining which design changes they will make to reduce production obstacles. Whether they want to make formerly separate systems communicate or make equipment less susceptible to supply chain backups, those opportunities exist, and pioneering parties have given valuable examples to inspire future attempts.
However, no matter which direction leaders go, they must always keep functionality at the heart of their progress. The pharmaceutical industry’s stringent regulations make creating designs that contribute to safe, consistent operations imperative. Impressive-looking innovations get noticed and praised, but it is even more important to offer high functionality that aligns with current or soon-to-be-enacted manufacturing requirements.
