Engineering with precision: from complexity to compliance in pharmaceutical facility design

As consumers, we tend to take for granted that the medications on our shelves and in our hospitals are safe and effective. You might occasionally buy a cheap pair of jeans that fall apart the second time you wear them or splash out on a piece of technology that doesn’t perform as advertised, but when it comes to pharmaceuticals, we expect safety and consistency every time.

This is because, unlike with clothing and other consumer goods, pharmaceuticals carry extreme risks that need to be carefully managed. This is frequently discussed in the context of developing new medicines and treatments, but also impacts the way in which new and existing pharmaceuticals are manufactured, and in the design and engineering requirements for the facilities they are produced in.

The gold standard in design

At the core of pharmaceutical production is Good Manufacturing Practice (GMP), a set of guidelines designed to ensure everything meets the required high standards of quality and safety, with a core focus on patient safety, product efficacy, and regulatory compliance.

GMP primarily focuses on the process of producing pharmaceuticals, from maintaining clean rooms to training personnel and preventing cross-contamination. But the design of the facility is a key factor in achieving these standards. For example, production lines must be laid out in a way as to make cross-contamination as difficult as possible. This includes everything from dedicated equipment and thorough cleaning process through to using completely closed units like isolators or manufacturing certain products in separate facilities.

While best practice exists for all industrial engineering, GMP differs in that the comfort of the workers has to come second to product safety, to safeguard the welfare of future consumers. This means that to reduce human-borne contaminants and other risk factors, workers may be required to take steps such as wearing multiple layers of gowning– which can limit mobility and cause heat stress.

Navigating the regulatory maze

To ensure safety standards are met, pharmaceutical industrial engineering must meet strict regulations. These vary from country to country, with Malaysia’s NPRA (National Pharmaceutical Regulatory Agency) for example requiring that the facility layout proposed during concept design be approved by the regulator before further design can commence.

This can cause significant challenges, with facilities required to not only meet the regulatory standards of their own country, but of every country into which they will export their product. Navigating this landscape requires experience, with any problem likely to cause delays in production, and in the availability of life-saving pharmaceuticals. A strong collaborative relationship between the designer, client and regulatory organizations is also key.

Innovating for the future

The wider industrials market is rapidly adopting new technologies to improve efficiency, expand capacity, and bring new products to market faster. However, innovation is by necessity a much slower process in pharmaceuticals, as any new technology must be qualified to meet the same rigorous standards as the rest of the pharmaceuticals industry.

Digitalization and Industry 4.0: While this is rapidly becoming widespread in other industries, digital tools are much more challenging to integrate into pharmaceuticals systems, as they must first be validated, documented, and risk assessed. For example, while some industrial chemical facilities are now experimenting with AI systems that can adjust flows in real time, improving quality and efficiency, in pharma these sorts of process changes require prior approval and a complex validation procedure.

Modular construction: When deployed in sterile environments and clean rooms, this must meet much higher standards including precise integration, validation of joints and seams, environmental control testing and more.

Automation and robotics: GMP compliant robotics must align with strict standards to maintain product integrity and protect consumer health. Key features include smooth, non-porous surfaces for easy cleaning, modular designs for thorough maintenance, and materials like stainless steel to prevent particle shedding. Low shedding seals and connectors minimize contamination, while automated cleaning systems enhance hygiene.

Continuous/flexible manufacturing: While other industries often leverage multipurpose equipment and can adapt processes for higher output, lower energy, and other key outcomes, this can conflict with safety controls for pharmaceuticals. Pharma traditionally uses batch-based manufacturing to meet regulatory controls and allow batch segregation and traceability, and any changeover would require cleaning validation, line clearance, and in the case of high-risk or sensitive products like hormones, completely dedicated equipment.

By working closely with technology providers and vendors, we help clients safely navigate the opportunities new technologies offer and ensure that innovation never comes at the expense of product safety.

Engineering for safety

Safety shapes every aspect of production, from the layout of the facility to what machinery can be employed, what materials can be used, and even the standard of the utilities. And while the pharmaceuticals industry is increasingly changing – with regulatory bodies increasingly looking to global standards, and innovative new techniques beginning to be trialled and adopted, change is necessarily slow and cautious.

Experienced industrial engineers are key to balancing these competing demands, driving progress while ensuring that the core principles of safety and quality are never compromised.