Is Your Cleanroom Smart Enough? The Rise of Real-Time Data Analytics in Biopharma

Biopharmaceutical manufacturing relies on many advanced technologies. Still, many pharma companies have room to improve when it comes to taking full advantage of everything modern tech has to offer. The growing field of real-time cleanroom monitoring is a prime example.

Investment in cleanroom technology could reach $5.6 billion by 2030, and smart devices account for much of this growth. As this trend continues, biopharma manufacturers who fail to capitalize on it may quickly lose their competitive edge.

What Technologies Does Cleanroom Monitoring Encompass?

The primary driver of smart cleanroom monitoring is the Internet of Things (IoT). IoT sensors gather data in real time and transmit it remotely to other endpoints for storage or use. This up-to-the-second process visibility forms the informational baseline for all other Industry 4.0 cleanroom technologies.

Of course, data alone does not produce any tangible value. Cleanroom operators must respond to this information once IoT devices have gathered it. One prominent way to do so is to analyze it through artificial intelligence (AI). While research and development accounts for most AI adoption in biopharma, production workflows have much to gain from it, too.

AI is a broad category, so it encompasses many specific use cases within cleanroom environments. Predictive maintenance (PdM), where AI predicts repair issues to alert technicians before larger problems occur, is among the most significant. However, it’s also one of the hardest to perfect, with fewer than 50% of PdM adopters saying the results have been satisfactory.

Other AI applications may analyze process data to find inefficiencies, informing long-term strategic improvements. In some cases, that means building digital twins to replicate the cleanroom environment virtually and simulate various changes to predict their likely outcome.

Smart cleanroom monitoring may also include cloud storage solutions, security software, robotics and software automation. Whatever the specifics, it revolves around technology to gather, manage and apply real-time data.

Why Pharma Manufacturers Need Real-Time Cleanroom Monitoring

Across all applications, smart cleanroom monitoring has many advantages. Long-term cost and time savings are at the forefront. While implementing such technology involves high upfront spending, it typically makes operations faster and more cost-effective over time.

PdM, for example, prevents equipment breakdowns better than conventional maintenance approaches and extends asset life spans. Consequently, it leads to higher uptime and less spending on repairs. Digital twin-informed process improvements have similar effects.

Monitoring cleanrooms in real time also ensures these facilities do what they’re supposed to: prevent contamination. The conditions needed to maintain sanitation vary between situations. An air exchange rate of 20 is enough when one person is present, but a rate of 35 is necessary with two employees. Consequently, HVAC systems must adapt according to current occupancy, and IoT solutions enable that.

Real-time analytics can also monitor sanitation equipment conditions to ensure they work as intended or calibrate testing machinery as necessary. Smart HVAC and similar systems can also minimize energy consumption to reduce cleanrooms’ environmental impact and electrical costs. Some advanced facilities can even use IoT-connected sensors to specifically track microbial contamination to catch instances of noncompliance as they emerge.

Despite these potential benefits, Industry 4.0 adoption in cleanrooms remains relatively low. Just 1% to 2% of biopharmaceutical processes use innovations like real-time analytics, even though the necessary tech has been available for years. The sector must close that gap to reach rising standards of efficiency, accuracy and sanitation.

Potential Risks of Smart Cleanroom Monitoring

Biopharmaceutical manufacturers cannot afford to overlook the advantages of smart monitoring. At the same time, it’s important to recognize the potential downsides of this technology. Desirable results are only achievable if organizations understand how things can go wrong.

Costs and complexity are the most obvious obstacles. Even though careful implementation will lower expenses over time, the initial burden is a lot for some companies to bear. The inherent complexity and unpredictability of biopharmaceutical production also make it difficult to apply automated technologies effectively, which can limit returns on investment (ROIs).

Cybersecurity is another concern. Manufacturers have become increasingly popular targets for cybercriminals, and higher IoT connectivity means a broader attack surface for them to take advantage of. There were over 112 million IoT malware attacks in 2022 alone, and this figure keeps rising, but many pharma companies lack the needed security knowledge or experience.

Impressive figures about AI and the IoT’s accuracy may also lead cleanroom employees to become complacent. They may overrely on technology, taking its suggestions at face value or paying less attention to proper workflow protocols, assuming smart tech will handle any issues. However, no system is perfect, so such overreliance could lead to errors or sanitation noncompliance.

How to Implement an Effective Cleanroom Monitoring System

In light of these potential problems, biopharma companies should approach cleanroom monitoring carefully. Effective design and implementation start with partnering with reliable hardware and software vendors. Manufacturers can look for standards like AS9100 or ISO 9001 to gain confidence in their resources’ quality, which will prevent errors or supply chain vulnerabilities.

Organizations should also identify relevant use cases for Industry 4.0 technologies before investing in them. IoT, AI and similar systems should always be a solution to an existing problem, so businesses must start by recognizing which issues they face that technology could solve. Applying tech to one specific and relevant area will make it easier to attain a positive ROI.

Along similar lines, employee training is also necessary. Nearly three in four workers lack needed digital skills, which can hinder ROIs and lead to errors. Putting cleanroom employees through training to learn how Industry 4.0 technologies work and how to use them effectively will ensure a smoother transition.

Finally, biopharma manufacturers must employ advanced cybersecurity measures. All IoT connections must use a separate network from other devices and encrypt their data transmissions. Every device needs a strong, unique password and multi-factor authentication to access. Automated security software like real-time network monitoring and automatic updates are also helpful.

A Smarter Cleanroom Is a More Reliable One

Smart cleanroom monitoring technology paves the way for higher standards of sanitation, safety, efficiency and accuracy. Biopharma companies can no longer overlook those benefits as demands rise and the industry becomes more competitive.

Implementing this technology is not easy. However, if organizations understand the largest downsides and address them during design and adoption, they can overcome such obstacles. They can then experience the full benefits of Industry 4.0.