Roadmap for Industry 4.0 in Pharmaceuticals

The process of quality control can be improved – in terms of time and quality, through new emerging technologies. What types of measures can pharma corporations take to become leaders in quality control?

The industry 4.0 is marked by emerging new technological advancements including connectivity processes, advanced analytics, automation and robotics. These advances have a strong tendency to transform every aspect of pharmaceutical-manufacturing laboratories in the next decade. The initial practical application has increased productivity levels by between thirty and forty percent in well-established and effective laboratory settings. It is estimated that a complete array of modifications can result in total quality-control expense reduction by over fifty percent. Automation and digitalization will improve quality performance and compliance standards by decreasing manual inaccuracies and inconsistency. In addition, it will support rapid and efficient problem-solving practices. The application cases have shown that variance can be lowered by over sixty five percent and closure periods can be shorted by more than ninety percent. Companies can save millions of dollars on their own by deterring major compliance issues. Enhanced responsiveness and reduced testing time can reduce the duration of the quality control laboratory by sixty to seventy percent, ultimately resulting in real-time releases.

At present, the majority of advanced technologies are already in existence, but a handful of pharmaceutical organizations have yet yield substantial advantages so far. Quality experts usually experience difficulties in outlining a definitive business case in favor of technological improvement, which poses challenges in convincing the upper management to the significant benefits of lab automation and digitization. Organizations rarely develop an extended-term laboratory improvement action plan and strategy, resulting in costly investment commitments with unsure benefits. For instances, many corporations have taken steps to adopt a paperless work environment by initially streamlining paper documents to reduce the frequency of entries followed by digitizing laboratory test records. These measures, now, are being outmoded by new development in equipment connectivity which allows for explicit transcription of large quantity of data packs without the need of manual data transcription or reviews.

In order to capitalize on the opportunities associated with current and new technological developments, organizations should define clear objectives, outline vigorous business case studies for all types of investment and participate in rapid pilot applications of emerging technologies tailored to rapid full-scale pilot applications with positive outcomes. In order to capture future success, pharmaceutical corporations must be prudent in developing long-term strategic investments – including research and development and new testing procedures and responsiveness to modify those strategies according to fast paced technological evolution.

Laboratory Evolution Lies in Three Horizons

In pharmaceutical lab sector, a wide array of automation and digital technologies have generated potential for modification and advancement. The majority of pharmaceutical labs are yet to accomplish digital transformation. These laboratories can work towards one of the three imminent horizons of technological development.

In digitalized labs, the operations are mostly conducted in a paperless environment. They have migrated from physical data transcription to automatic data transcription linking equipment and the general laboratory information management system (GLIMS).

Digitized labs use advanced real-time data analytics and continuous verification procedures to monitor trends, avoid inconsistencies or specification variance as well as achieve optimal scheduling. They use digital tools, such as smart glasses, to transform conventional operation processes into stepwise visual guidelines on ways to implement a process. A digital mirror lab is generated to project possible outcomes before actual physical modifications are implemented. These technological tools and systems are already in place and can be implemented in a short period of time for all scenarios.

By achieving a digital lab horizon, a typical chemical quality control laboratory can reduce its operating costs by between twenty-five and forty-five per cent. In a standard microbiological lab, possible cost reduction can reach anywhere between fifteen to thirty five percent.

Enhancement in productivity can originate from two major causes

1. Reduction of physical documentation workload by eighty percent, and
2. Automation and optimization of processes linked with planning and scheduling to strengthen employees, equipment and material usage.

With lower errors and digital assessment of the core problems, laboratories can reduce investigation work by almost ninety per cent.

Digitized labs also yield compliance enhancement advantages from lower error rates and inconsistency, along with smooth data assessment and retrieval. Higher productivity and scheduling flexibility can reduce the lead time by ten to twenty percent.

A major international pharmaceutical company has shifted to a digital lab, resulting in increased productivity. The organization used an advanced scheduling optimization system that used a modular, scalable digital mirror lab with both the ability to adjust the lab-related scheduling restraints. In addition, advanced analytics have been used to minimize variation by eighty per cent, completely eliminate recurring inconsistencies and accelerate the closing time by ninety per cent.

In a digitally enabled laboratory, repetitive processes such as sample preparation and delivery are achieved through robotic tools and sophisticated automation technologies. Tasks involving handling high-volume testing are done online rather than at a physical location. They also use predictive maintenance technologies to schedule infrequent tasks, such as equipment servicing and maintenance, performed by remote expert laboratory analysts.

In the pharma sector, it is not necessary to fully digitize a lab, but automated laboratories can use digitization to generate higher value and lower costs. These laboratories can achieve cost savings both inside and outside the lab through digital systems. Similar enhancements can be yield by automation at chemical laboratories. Productivity performance is elevated significantly in sample gathering and delivery processes and sample preparation operations through automation. Equipment maintenance expenses are also reduced by means of remote monitoring and failure prevention. Likewise, external operations like sampling and logistics can also be reduced by automated technologies.

Pharma companies can capture extra advantages than just productivity. Remote tracking and predictive-maintenance capacity built into the equipment can reduce downtime and eventually help companies reduce their use of expensive equipment such as insulators, near-infrared spectrometers and chromatography. Additionally, companies can adopt instantaneous microbial detector for environmental examining and decrease their lead period by forty to seventy five percent.

There are technological advancement existing in health care sector, research labs and manufacturing industry that can directly be applied to pharma-manufacturing laboratories to achieve automated-laboratory horizon. There are numerous solutions offered by vendors today to enable such development.

Distributed quality control processes are distinctively different from the standard quality control procedures. In such setups, most standard product testing follows a production line protocol, delivering real-time release testing (RTRT). The equipment and devices used at these centers possess artificial-intelligence abilities. Distributed quality control laboratories undertake specialized and continuous testing at external centralized locations. The application of process analytical technology (PAT) and RTRT is happening slowly due to regulatory filing protocols and approval standards. In order to achieve future smoother transition to online testing, operations must work with research and development to devise an optimum quality-control and filing action plan, particularly for emerging products and developing manufacturing centers.

Distributed quality control facilities generate added value by significantly lowering conventional footprint and laboratory costs. Due to essential research and development investment needs along with equipment requirements and operational changes, current facilities with constant or declining volumes are unlikely to provide a convincing business case for distributed quality control in the near or medium term. Simultaneously, facilities that are being built or growing in capacity can generate significant value by lowering investment in capital expenditure for the construction or upgrading of conventional quality control laboratories if they are able to shift a large portion of the standard testing to an online platform. Distributed quality control and real-time release have the potential to support solid continuous production systems.

In the strive to identify methods to develop distributed quality control sites, pharma corporations can adapt applicable technologies from other sectors. However, there are challenges and drawbacks that pharma companies can face in their standard implementation to achieve effective transition and value generation. As pharmaceutical laboratories develop, they face significant costs associated with automation and IT solutions. Also expensive solutions have the potential to generate high returns on investment, but most corporations find it difficult to tap into the value of digital improvement. The organizations can usually face the following difficulties:

• Focusing on automation instead of optimization. Organizational automation can yield two to three percent of quality control cost reduction whereas automation coupled with active scheduling optimization has the potential to produce higher value.
• Lack of having a convincing transformation business case. Many organizations start employing expensive IT solutions without a clear understanding of the full range of advantages that such systems can produce. As a result, there are delays in employment and rollout of restricted solutions. For example, labs may shift to paperless environment on individual units, but may require substantial manual endeavors to transfer date between systems. The result can be a scenario where analysts need to record test results on paper prior to manually entering the information into a laboratory information-management system (LIMS). The manual entry process inhibits the labs from tapping into the complete cost savings they can obtain from automated documentation.
• Lack of definite vision of what evolution horizon can be an appropriate goal for a specific type of laboratory. While many labs can create a solid business case for the digitally enabled future horizon, not every lab has the right volume and operational setup to justify an investment in automation as well as distributed quality control. For instance, it may be difficult to justify a financial investment in the automation of a small-scale laboratory setup while similar investment can produce optimistic return on investment for a larger facility.
• Targeting a prototype that has been extensively tested instead of evaluating and quickly scaling up high-value solutions to capture short-term gains. For example, both scheduled automation and optimization can be used quickly and start generating significant value even if the laboratory is not completely paperless and completely digitized.
• Lack of complete comprehension of the system capabilities they have purchased. Pharmaceutical corporations can purchase a system like LIMS to comply with data integrity regulations without a proper comprehension of the system’s capability to improve productivity.
• Not having appropriate planning and management for the implementation of the latest methods and technologies. In extreme situations, pharma organizations may require many years and huge investment to employ LIMS. Given such a long timeframe and rapid changes in technological advancement, certain LIMS aspects may become invalid and antiquated even before they are implemented across the network. Pharmaceutical corporations require the ability to implement these systems quickly and avoid unnecessary customization at every location. Improper implementation efforts can cost a lot of time and money than well-planned investment with a clear long-term strategy.
• Committing insufficient time and work on devising a comprehensive change-management program. Digital modification involves drastic changes in vision and attitude and offer significant implications for the organization and its employees who are needed to develop new capabilities and talents. To excel, companies must to modify the culture and develop strong bonds between business division and IT functions.
• Restrictions to authenticate every technology and system. Most changes, such as optimal scheduling or data-enabled deviation assessment, do not require authentication and refilling.
• Lack of capability pool to obtain complete value from the data. Many standard pharma labs lack advanced analytical skills required to extract maximum value from available data. As a result, labs do gather data but do not utilize it appropriately to generate perpectives that can help avoid issues or minimize testing volumes.

Where to Start?

the Majority of technologies that is required to achieve one of three horizons associated with Industry 4.0 quality control labs are already available, which is a positive aspect. Many technologies are currently employed in the pharma sector with several successful pilot cases completed and many others in the approval phase.

In order to achieve the effective application of Industry 4.0 technological advancements, pharmaceutical corporations must set appropriate goals and work swiftly to achieve them. They can start the process by doing the following things:

• Test quickly several application scenarios and technologies and determine the best option for each type of laboratory.
• Establish lighthouse quality control labs to exhibit the potential advantages of integrating these innovations.
• Create definite goal scenarios and business cases for each type of laboratory in the early stages. Monitor the value generation and reinvest savings in future technological improvements. It is essential to develop separate assessment for chemical and micro labs as baseline expenses will vary considerably.
• Develop a core pool of talent and capabilities right from the start. Companies must be aware of future skills requirements, commit to the training of talented staff and spend time hiring staff with the new skills needed to achieve speedy implementation in the initial phase.
• Identify and quickly implement innovative technology tools with the maximum immediate effect across different sites. Don’t get stuck attempting to establish a functional lab with all conceivable desirable technology. Most companies employ use cases like scheduling optimization which can be employed prior to other aspects.
• Maximize the value justified by the business case when setting up new laboratories to avoid the need for additional upgrades immediately following the opening of the laboratory.

Existing and emerging technological advancements can provide a faster, more responsive, more competent, more compliant and effective quality control process. Companies must define clear objectives, identify and select appropriate technologies and implement them quickly in order to become leaders in quality control and extract benefits in the form of speed, higher specification conformity, reduced costs and improved productivity performance.