Pharma’s top 4 operational challenges

July 21, 2023
From data protection to unplanned downtime, modern challenges require out-of-the-box solutions

With further growth expected in the future, the pharmaceutical market is witnessing innovation in equipment, research and products. This innovation, however, has resulted in operational challenges for pharma manufacturers.

As a result, businesses and market share are suffering while overheads rise, adding complexity to an already competitive marketplace.

The pharma industry has always faced various operational challenges; most were overcome by increasing investment, replacing equipment or hiring professionals. But in this current age of information abundance, operational challenges have become more advanced and are calling for innovative solutions.

Here are pharma’s biggest operational hurdles — and how to mitigate them:

1. Data protection

Today’s pharma industry relies heavily on data for the execution of the production process, troubleshooting faults and assuring quality. These data sets are an integral asset for the pharma industry because they contain critical information on production, product formulation, assets, and pharma organizations’ quality and production policies. 

Many data sets in the pharma industry are generated as a byproduct of modern technological applications, such as IoT, process automation and paperless manufacturing. These data sets represent critical pharma processes and product manufacturing parameters in an electronic form — previously recorded and generated manually.

The protection of these data sets is paramount, but they face multiple threats due to web-based applications, electronic data generation and storage and networks for data communication.

2. Energy costs

Increased energy cost is a significant operational challenge for the pharma industry. It decreases the profit margins of pharma organizations and affects their ability to deliver quality products in the long run.

Energy consumption in the pharma industry is somewhat different than in other industries. In addition to running the pharma production process, energy is also required to keep the area production-ready by maintaining the required environmental parameters, cleanliness levels and strict contamination control.

A major energy consumer in the pharma industry is the heating, ventilation and air conditioning (HVAC) system. It maintains specific environmental parameters such as temperature, humidity, air changes and pressure profiles within limits, during both production and non-production hours.

3.  Unplanned downtime

Unplanned downtime prevents manufacturers from delivering products on time. It also affects the quality of the final product because continuous stop-start-stop work often fails to yield consistent operational qualities.

A major cause of unplanned downtime is equipment failure and breakdowns that occur unexpectedly, as well as the lack of maintenance to keep equipment functioning properly. Also, waiting until equipment fails before repairing it can lead to higher maintenance costs and long periods of unplanned downtime, resulting in missed production goals.

Other reasons for unplanned downtime could be:

  • >The unavailability of spare parts
  • Lack of skilled labor to handle the manufacturing process
  • Not following equipment manufacturers' guidelines

4. Process variability

Process variability is the inability to produce a product with consistent quality and effective results. It's one of the biggest industry challenges and erodes patient trust. The manufacturer can run into regulatory trouble and even have manufacturing operations shut down.

There are many reasons for process variability, one being a diversified supply chain. It is possible that the same raw material, if supplied by different sources, can have varying material characteristics which lead to variation in the manufacturing process.

Aging pharma facilities might be another reason. An outdated pharma facility could lack basic regulatory requirements, such as environmental control characteristics, testing facilities and updated production equipment. Factors like these can significantly reduce a pharma manufacturer's ability to create consistent processes and products.

How to mitigate operational challenges

Advanced manufacturing process control

Advanced process control is a process automation technique that automatically adjusts various process parameters in a manufacturing operation. It minimizes human involvement in setting, adjusting, and aligning these parameters to the product requirements.

It uses various monitoring systems such as temperature monitors, flow meters and pressure sensors to monitor the present state of the production process and adjusts multiple process parameters such as input temperature, infeed flow and airflow.

The advantage of advanced process control is that it provides stricter control of process variation — a common problem in pharma manufacturing. It also enables makes the production process more energy efficient by adjusting parameters in response to changing energy requirements. In contrast, human workers can only adjust parameters in response to the current production state.

Cybersecurity measures

Cybersecurity measures are an effective way to deal with challenges related to data protection. They help pharma manufacturers protect their critical data, collected and stored through online resources and automation systems. Without these cybersecurity measures, pharma organizations could experience:

  • An increase in cyberattacks, leading to disruption in process control
  • Theft of critical data, such as product identification and formulation
  • Process and electronic record disruption for regulatory bodies during their routine inspections

Effective cybersecurity measures that can help pharma manufacturers overcome data protection challenges include: 

  • Hiring a cybersecurity expert specifically dealing with cyber threats, hazards and remedial techniques 
  • Expanding the capabilities of the existing information technology department in dealing with data protection issues
  • Developing a monitoring system across various nodes, architecture and network layers to detect any potential threat
  •  Creating an encryption mechanism for data transmission and collection 
  •  Updating existing software architecture to deal with new cyber threats

Software solutions across departments

Using manufacturing software in the operational life cycle is becoming more and more common. It automates mundane tasks involved in performing critical functions, such as planning, resource allocation and report management. Human workers only need to create workflows in accordance with the organizational policies and regulatory body guidelines.

ERP software enables a pharma organization to interlink its departments and streamline its routine operations to meet market demands, quality requirements and regulatory guidelines. Software solutions across various departments can also be integrated with predictive analytics. Using historical data, the software can predict future machine performance. This data is used for production-optimization decisions such as production planning, purchasing raw materials and market forecasting.

As another example, a computerized maintenance management system (CMMS) for planning maintenance activities throughout plant equipment helps pharma organizations face challenges by:

  • Producing timely reports of current production
  • Communicating effectively
  • Planning for various organizational departments such as warehouse, production, engineering, and the supply chain
  • Helps to execute critical functions from a single location

Predictive maintenance

Predictive maintenance predicts failure and alerts maintenance teams before an actual fault occurs. It continuously monitors the performance of various components, such as motors and instrumentation systems, and initiates maintenance when specific metrics from these components drop below a threshold value.

Predictive maintenance is an excellent tool for detecting and reducing unplanned downtime. It allows maintenance personnel to observe the conditions of various machine components individually so they can plan maintenance of components at the brink of breakdown.

Predictive maintenance also solves the problem of neglected maintenance by continuously providing insight into a machine's performance. It helps maintenance personnel focus on urgent and emergency cases instead of less urgent ones.

Personnel training

A well-trained operator:

  • Helps prevent data theft by accurately following the approved and secure operating procedures laid down by the IT department
  • Enables operators and personnel to understand predictive analytics and make appropriate decisions
  • Understands the relationship between product and equipment, enabling the operator to adjust process parameters such as temperature, speed and mixing time to prevent process and product variability

Training empowers the whole workforce to be aware of the challenges an organization faces, its present state in meeting these challenges, and its future goals and targets. Personnel training can include:

  • Process safety: safely executing of processes and producing safe products for human consumption
  • Process hazards: executing processes by considering and minimizing all the hazards during the production process, such as electrical and mechanical 
  • Safe products: producing products with approved and acceptable specifications for human consumption

For instance, certain personnel may be trained to operate the production process with a higher safety requirement. In that case, they can help a pharma organization overcome challenges by preventing accidents, producing accurate drugs, reducing wastage and ensuring high quality in final products.

New challenges, new solutions

Increasing knowledge, data, and availability have made pharma manufacturing more controllable and predictable. It helps workers understand possible problems and prepare for the challenges and regulatory inspection. However, these latest trends also create new challenges for the pharma industry that were not known in the era of manual operations.

These challenges require out-of-the-box solutions for the latest product and quality issues. It also helps a pharma manufacturer to devise innovative ways for faster development and quality enhancement throughout its production processes.

About the Author

Eric Whitley | Director of Smart Manufacturing, L2L