IIoT, Industry 4.0 and the Pharmaceutical Manufacturing sector

Industrial IoT and its impact on pharmaceutical manufacturing 

Industry 4.0, The Industrial Internet of Things (IIoT), Operational Excellence, Smart Manufacturing, and Connected Data, are industry terms that are becoming increasingly important to the continued success and competitiveness of today’s global manufacturer, in the dawning of the 4th Industrial Revolution. 

Like many other industries, the pharmaceutical sector is challenged with several obstacles when it comes to developing, producing and marketing products such as medical devices and brand medications.  These challenges include improving product quality, tracking products, ensuring regulatory compliance, reducing lead times, improving efficiency, reducing scrap, reducing inventory, reducing downtime and connecting the supply chain.

Pharmaceutical companies must meet strict regulations regarding environmental issues, undergo Quality Control (QC), apply Statistical Process Control (SPC) and keep Electronic Batch Records (EBR) throughout the manufacturing process.  As one of the most regulated industries facing increasing market pressure, pharmaceutical manufacturers must price their products competitively.  To achieve this, their operational processes must be at their most efficient, whilst continually maintaining quality and meeting compliance requirements. 

The fourth industrial revolution is the move towards digitisation.  Cyber physical systems such as smart sensors can produce data that can be quickly acted on.  When the quality, safety and traceability of products is paramount, such systems can only be a positive thing, right?  Only if the data generated from the systems is analysed properly to make timely, quality decisions, based on facts, does it become meaningful.  But many manufacturers are putting themselves at risk by using archaic paper-based systems to support quality and traceability.  IoT is about integration and how people, processes and systems talk to each other, which largely doesn’t happen unless automated systems have already been adopted.  Connecting data from the automation environment into the IoT and big data cloud is a tough challenge for pharmaceutical manufacturers.  Collecting the right data is just the beginning; getting the right kind of systems and people to analyse the data so that the best decisions can be made is the tricky bit.

The tangible benefits of IIoT and Industry 4.0

Global healthcare organisations and pharma players in the industry can see great success and benefits from integrating Industry 4.0 technologies, such as optimising the workflow and manufacturing processes, complying with strict standards and regulation, enabling root cause analysis and alerts for better product quality and performance.  The management of real-time electronic batch records (EBRs), process validation audit trails (defined by workflow and procedures) and electronic signatures offer a reliable, digital solution for performance management, quality improvement and productivity.

Software systems such as electronic device history records (eDHRs) allow medical device manufacturers to maintain device history records for each batch, lot and unit they produce, supporting compliance with 21 CFR Part 11 standards throughout the manufacturing process.  IoT-enabled systems can be utilised to help manufacturers benefit from a reduction in waste (of labour, materials, time and energy), follow government compliance, meet optimum product lifecycle times and achieve tighter margins.

Implementing well-established technologies such as manufacturing operations management (MOM) systems, electronic quality management systems (EQMS) and traceability systems can offer many benefits to the pharmaceutical sector, including a fast and effective solution to improve output, quality, and reporting – all while meeting regulatory compliance requirements – offering real-time data and information for analysis and action. 

Watch our on-demand Webinar "The key drivers to IIoT technology adoption in the pharmaceutical manufacturing sector" 

Cimlogic have a wealth of experience supporting pharmaceutical manufacturers in realising the benefits of IIoT.  Take a look at this whitepaper 'Tackling the Challenges of Pharmaceutical Manufacturing' from Parsec Corp, developers of TrakSYS™, leading real-time operations and performance management software.  Cimlogic are the only gold tier TrakSYS™ implementation partner in the UK.

If you'd like to discuss Industry 4.0 and our IoT enabled technology systems further please call +44(0)1274 59995 or email enquiries@cimlogic.co.uk.