July 1, 2021

Pharma 4.0 – Road to the Smart factory

Smart factory development is a top priority for manufacturers across all industries and sectors. It is a component of a business’s digital transformation, and it is critical to maintaining competitiveness while also meeting the demands of consumers and end-users, as well as B2B customers and regulators.

This is all part of Industry 4.0, the umbrella term for the revolution currently sweeping the manufacturing sector.

As with previous industrial revolutions, Industry 4.0 will evolve over many years and decades as new technologies and processes are developed, and as businesses, regulators, and consumers grow.

What are the critical smart factory developments worth examining today if you work in the pharmaceutical or medical technology industries?

Why is Industry 4.0 even more critical to the pharmaceutical manufacturing industry?

1. Increased Productivity — Automating processes enables them to be completed more quickly and accurately. Reduce downtime through automation and the use of sensors and predictive systems that enable equipment to function autonomously.
2. Improving the supply chain’s efficiency through integration –  They are making it feasible to transition from batch to continuous manufacturing, a production approach that results in much less downtime and increased efficiency.
3. Increased Quality – Increased automation and continual monitoring of your manufacturing plant will result in fewer mistakes and higher-quality final products.
4. Risk Reduction – This follows naturally from the preceding two arguments – increased manufacturing precision reduces the danger of substandard items reaching end customers.
5. Facilitates Regulatory Compliance –  Compliance with existing and upcoming laws in the E.U. and other parts of the globe is made more accessible via the use of Industry 4.0 technology. To comply with the Falsified Medicines Directive, new track and trace systems and serialization solutions are presently being deployed.
6. Improved Business Oversight  – Industry 4.0 technologies enable real-time reporting, increased data collection, improved data analysis, and improved data presentation in usable formats.
7. Development Of New Business Prospects –  Industry 4.0 will also open up new commercial prospects for pharmaceutical businesses. For instance, Industry 4.0 technologies enable seamless and highly efficient end-to-end supply chain integration. This increases productivity, which helps your business immediately. A more connected and efficient supply chain, on the other hand, is also more scalable, opening up new potential for your organization. Covid-19, a quick-win situation.
8. Increased Profitability – When all of the aforementioned are combined, the outcome is improved corporate profitability. Additionally, your firm will be more competitive and better able to address future difficulties and opportunities. Covid-19 has accelerated the advancement of biotechnology problems.

The pharmaceutical industry has only recently begun to adopt Industry 4.0 technologies, despite the fact that it has been using batch manufacturing for more than 50 years. However, the traditional batch process technique has been demonstrated to be lengthy: after each stage in the process, production is generally halted to allow for quality assurance testing of the material. Each break lengthens the lead time and increases the likelihood of defects and errors (FDA, 2016).

This encouragement comes at a critical time – we are entering an era of precision (personalized) medicine, “where medicines must be produced with unique characteristics and made available to people in need more rapidly.” (U.S. Food and Drug Administration, 2016).

To create customized medications, pharmaceutical companies no longer need to produce large batches but rather tiny ones tailored to a limited group of individuals who require a certain treatment in a specific dosage. Batch production is not the answer to these demands, but continuous manufacturing that is connected, smart, adaptable, and accurate.

Continuous manufacturing is used in the pharmaceutical business to move substances nonstop inside the same facility, eliminating wait times between process steps; the materials are fed via an assembly line of integrated components. Manufacturing that is continuous “saves time, decreases the risk of human mistakes, and enables a more agile response to market changes. It can operate for an extended length of time, potentially reducing the probability of medication shortages.” (U.S. Food and Drug Administration, 2017).

Pharma Opportunities 4.0

• Gains in economic terms, such as greater revenues as a result of reduced transaction costs
• Increased reliability and consistency in production and output, as well as higher-quality products
• Energy-efficient and ecologically friendly manufacturing systems
• Utilization of human and material resources effectively.
• Changes in work structure, with a greater emphasis on remote, flexible, and on-demand labor

Pharma 4.0’s Obstacles

• Gaps in infrastructure
• Policies and regulations that are out of date and do not take into account 4.0 Industry
• Ownership and security of data
• Transparency, confidentiality, and ethics
• Changes in the fundamental characteristics of innovation processes and their implications for competition and entry barriers

Take away points

We may now re-evaluate our industry’s accomplishments while simultaneously re-strategizing our future strategy toward offering high-quality therapy at scale and bringing fresh hope to humanity.

By strategically integrating the production process, we as an industry will be able to stay ahead of the problems and expectations on which the rest of the world is so reliant.

Predictive analytics enables you to foresee issues, minimize risks, capitalize on opportunities, and ensure that resources are directed appropriately.

Predictive analytics is already being used by pharmaceutical and medical device makers in the field of equipment maintenance. It is possible to forecast the effect of a variable on a piece of equipment, a production line, or a process using technology such as digital twins.

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Makoro™ leverages #AppliedArtificialIntelligence and #NaturalLanguageRecommendations powered by #DigitalTwin in solving transformative problems in the manufacturing supply chain. 

If you are still leading with reports and dashboards, you are falling behind. You are leaving money at the table. When you can shave off minutes and hours you spend making the right decisions on your assets.  

Asset performance recommendations from Makoro™ deliver improved asset and process performance consistently through recommendations. These recommendations are backed by data and can be traced to the sources of data. 

Makoro™ recommendations deliver direct operations savings and indirect compliance savings.