Aseptic manufacturing – that is, the handling of sterile products and devices in a controlled and regulated environment – has always been integral to pharmaceutical manufacturing. But since the Covid-19 pandemic, sterile manufacturing capacity within the pharmaceutical industry has seen even greater demand.
Valued at $73.4 billion (£58 billion) in 2020, the global aseptic processing market is projected to grow to $133.2 billion (£105.2 billion) by the year 2030.
A marked growth in sterile manufacturing processes with single-use technologies such as tubing, mixers, capsule filters and bioreactors has been noted. So how will manufacturers adapt their facilities in line with these requirements?
Increasing sterile capacity
In a market that is expanding quickly, manufacturers need to move fast to create move sterile capacity and grab their ‘piece of the pie’. However, there are challenges in ramping up sterile capacity; specifically, the time and resources required to make necessary changes.
From qualification to validation, creating sterile capacity takes time and demands an investment in equipment and training. These aspects might be prohibitive for manufacturers considering making changes to their facilities, but there is evidence to suggest that aseptic single-use components provide opportunities for cost savings over the long term. Fewer utilities and measuring instruments are required in single-use systems, meaning less installation and a reduced number of support systems.
Research shows that single-use technologies can offer cost savings of around 30 per cent.
Nurturing flexible personnel
At IES, cross-training plays a huge role in allowing us to nurture multi-talented professionals with broad skillsets, able to play a part across our engineering operations. The same principle certainly applies when it comes to pharmaceutical manufacturers transforming their sterile production.
Workers who are trained in sterile aseptic production can be scarce, but the option of employing underskilled workers to fill this talent gap is fraught with risk, potentially leading to substandard, inefficient operations. Upskilling programmes can be the answer, with the required skills for a changeover being mapped, providing the foundation for the design of training courses for new activities. Pairing experienced team members with those who require upskilling for sterile production lines has proven effective in this respect. In the long run, worker skills across all production lines can aim for a parallel that offers much-needed flexibility to meet needs in an evolving plant.
Incorporation of digital performance management
Data-driven decision-making and digital performance management can be key to upping sterile capacity successfully. The changeover time on production lines can be brought down by digital methodologies for standardising and refining processes. Analytics can also play an important role in troubleshooting and the prevention of speed losses when expanding sterile capacity.
Manufacturers with ready and operational Industrial Internet of Things (IIoT) networks will clearly have an advantage here. By tracking every production step from compounding to packaging, and feeding data into quality assurance and maintenance, increasing a plant’s sterile capacity doesn’t necessarily mean a drop in overall equipment effectiveness (OEE).
Grasping the opportunity of sterile capacity demand
In order to grasp the opportunity presented by the heightened demand for sterile capacity, manufacturers will need to enhance their production processes, while maximising the potential of their material and human resources. Transforming operations to accommodate advanced aseptic technology goes beyond simply expanding capacity. Done well, it can offer long-term benefits for pharmaceutical manufacturers; taking advantage of a changing market while digitally resetting their facilities and broadening the skillsets of their workforce.
How can IES support clients facing issues such as a reduced workforce and supply chain changes? Learn about The Advantages of Flexible Engineering Services.
