Process Safety in the Pharmaceutical Industry

It is essential to be able to identify, assess and mitigate threats at each stage of the pharmaceutical engineering development pipeline. Increasing the scale of drug development processes from small lab-based synthesis to full-scale manufacturing is not without its difficulties.  

Medical and pharmaceutical manufacturing products should be identical across all batches and have consistent, easy-to-read packaging and instructions. Process safety ensures all of this is carried out by the manufacturing with no room for errors. 

Process safety: the key consideration for safe scale-up 

To achieve a successful scale-up, both the hazard assessment and the product development journey must be detailed and rigorous. Hazard evaluation needs to be considered early on and carried out throughout the entire development process. 

A systemic approach is required so that colleagues from all teams in the organisation can work together effectively. To ensure reliable performance, always put safety first over other criteria and keep safety a key consideration. 

Process safety in the pharmaceutical industry can be broken down into three areas. By completing all the stages, you can work towards achieving a safe and efficient environment. The three steps are: 

  • Screening for possible hazards 
  • Evaluating main reactions, including any potential unintended side reactions, and mitigating the hazards that are present; and 
  • Recognising the effects of “what if” scenarios to introduce appropriate safety and control strategies. 

 Pharmaceutical companies should be aware that new process safety threats can emerge at any time. You can never be completely sure, and no two accidents are exactly the same. They require a mindset that is always questioning to process safety in the context of challenges with product development. 

Replicating achievements with robust process safety culture 

There is strong evidence that a good process safety culture is necessary at all stages of laboratory, bench, and production work. Investigations into catastrophic events have identified repeatedly that weakness in safety culture is a factor in serious accidents. 

To ensure safety changes are effective, it is important to establish a strong safety culture within an organisation from the beginning. Creating a lasting culture takes consistent, deliberate action and being prepared with process safety procedures. In essence, it is the creation of a new normal, one that spans across all staff changes and management concerns. 

Expertise and insight 

Process safety expertise from experienced professionals working across the process workflow must be a feature when making decisions. Their insights into risk mitigation can offer great support from a manufacturing perspective and shape material testing constructively. Adding the concepts of safety mindfulness helps direct the workings for all professionals throughout the workflow. 

These changes in safety culture will increase the company’s efficiency and reliability. Process safety can help design a very safe process with as few hazards as possible. However, it is up to the company to determine how to bring a product safely and efficiently to market.  

Our pharmaceutical engineering consultants at FESS Group can help manufacturers to get the process safety part of their operations right. They can assist with building quality control systems that meet the tight tolerances needed by patients and regulators. Contact us today to find out more about how our pharmaceutical engineering experts can help you.  


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