With the pharmaceutical industry being highly regulated through official bodies, data is becoming even more precious - and with that the fear of security breaches. The manufacturing of sterile pharmaceutical products has not materially changed in decades, resulting in the same compliance-related issues and manufacturing challenges from year to year.
Some companies start utilizing electronic batch records and data evaluation, but for the most part we still rely on varying levels of manual data entry with little connectivity of data gathering systems. A broader use of process analytics has yet to take a foothold in the industry. Control systems operate separately and independently, rarely exchanging information. Environmental monitoring relies on the placement, incubation, and reading of media. The result of this lack of technological advancement can be seen in:
Lack of productivity: Today, many, if not most, companies operate largely on a four- to five-day per week, single-shift schedule, despite modern clean-rooms being designed to operate at high capacity levels around the clock.
Lack of scientifically based decision making:Sterility assurance is based on the observation performance surrogates, such as media fills, environmental monitoring, and end-product testing, where the correlation between what is observed and the desired state of product sterility is vague.
Under-informed decision making: We treat environmental microorganisms as direct indicators of product contamination, even though we have yet to quantify the scientific relationship between environmental conditions and product sterility.
Human performance variation: We tend to rely on significant human intervention in filling operations, both conventional and isolator. Most material transfers and clean-room disinfection are manual. Filling and environmental monitoring setup and performance are largely manual. We do little to consider ergonomics or process design for human error prevention, relying instead on often ineffective training methods to prevent and correct human performance issues.
Fear to challenge: We acknowledge the need for improvement and the desire to embrace technology, but we place more emphasis on regulatory expectations than on critical and risk-based thinking, often fearing the risk of regulatory scrutiny and burden more than enjoying the benefits of innovative methods.
The future improvement lies in better use of technology to meet the requirements of existing products and new therapies. The next generation operating model will benefit from automation, virtual reality, artificial intelligence, machine learning, and predictive modeling. These could lead to technology advances in contamination control using barrier systems, such as isolators and closed RABS (restricted access barrier systems), closed container filling, post aseptic lethal treatments, lower temperature terminal sterilization, rapid microbiological monitoring and testing methods.
Continuous process manufacturing and parametric or real-time release for sterile products could bring higher productivity. Facilities of the future could be modular, with a trend to smaller, less complex, and easier to control critical product exposure spaces. All these technologies exist today and could benefit the industry.
Regulators are ready
Globally, health authorities and regulators are encouraging new approaches. EMA, PIC/S, and the FDA are suggesting and expecting the use of risk-based approaches to process design and control. This opens the door for the industry to consider and propose new approaches.
Industry 4.0 is here and waiting
There is a significant opportunity to acquire and link data at unprecedented levels. This information and knowledge can be used to better model, predict, and control aseptic processes. Virtual reality and simulation can be used to design facilities, plan and address problems in simulation without putting at risk actual plant operations, provide more effective training, more expeditious qualification, and higher levels of worker awareness. Artificial intelligence and machine learning can use data to optimize processes and process control.
The workforce is changing
It is becoming more difficult to attract, train, and keep technical resources. The lack of enough skilled, qualified manufacturing personnel will result in the use of more automation, continuous process manufacturing, and smaller, less complex plants. In addition, innovation and cutting-edge technology will help attract the young technical talent needed by the industry.
The Opportunity for Manufacturing Improvement
For the industry to meet the needs the future will demand, it must improve its use of technology. Critical thinking and science-based decision making will lead to better selection, adoption, and use of technology for any process improvements. Critical thinking means making reasoned judgments that are logical and well thought out. It is a way of thinking in which one does not accept all arguments and conclusions but asks why and why not.
Productivity Vs. Quality
Process control and productivity are improved through the use of new technology. Embracing new technology requires financial investment. The return on this investment is often regarded in terms of cost of quality. But, technology does not necessarily increase manufacturing cost. It is important to recognize that controlling manufacturing cost and improving process quality are not mutually exclusive, conflicting objectives. Investing in technology to achieve a higher level of process quality can have positive returns in both quality and productivity. Quality processes and designs result in fewer defects, failures, and investigations, higher yields, and lower costs. Higher yields are a good indicator of a well-controlled, managed, reliable quality process. Reliable quality processes and higher productivity can mitigate drug product shortages.
Here are just some examples of how aseptic processing productivity can be improved:
Cleanrooms are designed to operate 24/7, yet today many aseptic process operations are limited to single-shift five-day production. Extending aseptic filling processes longer could increase output and productivity by 300 percent, while reducing downtime, changeovers, and the errors that result from start-ups.
Data acquisition and analysis is available at unprecedented levels. Using manufacturing intelligence, Big Data, artificial intelligence, and process analytical technology can provide better process understanding, control, and decisions through predictive modeling, real-time release, and process parameter and environmental monitoring trend analysis.
Where processes rely on human performance, focusing on automation technology can reduce or eliminate the source and impact of personnel-related process weakness, variability, and contamination.
The global pharmaceutical packaging market is expected to reach an estimated $86.4 billion by 2023 and is forecast to grow at a CAGR of 5.5% from 2018 to 2023. Emerging markets such as India, China, Brazil, Russia, and Turkey are providing an excellent growth opportunity for the pharmaceutical industry. The rise in outsourcing of pharmaceutical manufacturing to emerging economies is expected to open new growth avenues for the market. The stability of these economies coupled with favorable government policies is expected to have a positive impact on the pharmaceutical packaging market demand.
The pharmaceutical packaging industry has to balance complex considerations such as developing good designs and communicating with customers. Manufacturers should also look into pressing concerns that include counterfeiting, patient compliance, drug integrity and balancing child-resistance & accessibility for the elderly. These concerns have resulted in increasing costs of packaging for pharmaceutical products. The costs involved in the development of new products are also expected to increase the packaging price of these pharmaceuticals.
As agile methods are transforming the industry, Lean.IQ always incorporates continuously updated industry know-how and remarkable market insights as a distinguishing feature. In projects with our clients this gives us an advantage for a systematic and fast-moving approach for designing and developing innovations, companies find themselves struggling to keep up with market changes.
The selected topics covered:
Developments in mature and emerging markets
Managing complexity leading to a rising demand for contract packaging
Improved manufacturing efficiency in bio-pharma
IP due diligence for primary and secondary packaging machinery
Packaging solutions for the digital future
Integrated blockchain technology as an opportunity to increase trust and transparency throughout the entire supply chain
Performance in the aftermarket
With this comprehensive information Lean.IQ is offering machine builders and brownfield operations the opportunity to significantly accelerate innovation projects. And when it comes to mechanical / electrical engineering support or automation solutions we have the capability to meet our clients on eye-level.
You want to learn more about industry specific use cases or you already have an idea in place? Then come on and talk to us!