Spotlight series

The challenge: Optical inspection in (sterile) fill-finish processes in the pharmaceutical industry is a highly complex matter, often characterized by hybrid ways of working: from fully automated to semi-automated and even fully manual. Its execution is governed by several rules and requires an unusually high degree of special case handling. At the same time, the documentation of results, in particular error codes, is complex and cumbersome. This is not an easy task for the operators of the manual parts of the process, who must constantly balance between correctness in execution and documentation with process efficiency.

Most “classic” MES solutions hit a barrier with this type of process due to its complex setup. Unfortunately, this is often at the expense of the operator, who has to handle an inflexible, complex, and non-user-friendly functional setup at the user interface level that is not adapted to the way of working in this specific environment.

The solution: This is the point where low-code solutions such as Tulip excel. Their strength lies in flexibility combined with ergonomic design patterns, along with a fast-track and streamlined deployment and validation approach. At the same time, modern low-code solutions offer a comprehensive range of functionality, meeting the expectations and requirements of any MES solution in the life sciences process space. Whether you use it as your main MES or to cover specific process steps such as optical inspection complementary to a mainstream MES platform, the solution will demonstrate its strengths:

• A full suite of interfaces and integration technologies allows for top-floor to shop-floor integration. With regard to level 1 and 2 automation systems, the solution is designed to capture all relevant data from automated and semi-automated processes.
• The solution's ergonomic and user-friendly design guides operators through all steps of the manual process, supporting all required special-case handling.
• The solution is part of our MES Batch Recording Application Suite, which is integrated with our standardized event capturing and handling, as well as review-by-exception processes.
• If not used as the main MES, but as a complementary process management solution, our app suite provides standard interface setup for integration with existing MES. This will enable you to delegate the execution of the optical inspection step to Tulip, and then receive all relevant batch record data post-process completion.

 

Low-code platforms, in our case here Tulip, are the solution for adapting digital solutions to specific processes and achieving a truly digitalized workflow in a user-friendly way. These platforms allow for rapid development and deployment of customized solutions, ensuring that the digital tools align perfectly with the unique needs of the manufacturing process.

Envision a scenario where your operators can streamline their optical inspection workflows on a screen like this (example screens only), rather than having to resort to a standard MES workflow GUI that is often perceived as cumbersome:

At operator level:

 

At supervisor level:

Transforming to digital documentation and digitalized quality event handling not only enhances compliance and efficiency but also significantly reduces the risk of human error. By leveraging low-code platforms, pharmaceutical manufacturers can achieve a seamless, digitalized process that ensures quality and compliance at every step, thus enabling you to remain competitive in a rapidly evolving industry and to meet the stringent regulatory requirements.

The challenge: In the highly regulated pharmaceutical manufacturing industry, ensuring quality and compliance is critical. Traditional paper batch documentation requires meticulous page-by-page review, which is not only time-consuming but also prone to human error. This manual process can lead to delays and inconsistencies, impacting overall product quality and compliance.

Electronic systems are the more efficient alternative. They must have defined limits for process values and structures. These systems should automatically check against these limits and raise a quality event if breached. The review of electronic documentation should focus on deviations from the defined process, known as quality events. This shift in focus will streamline the review process. However, only if the electronic systems are properly implemented and utilized.

The solution: A comprehensive digital solution for quality event handling in pharmaceutical manufacturing is the only way to address these challenges.

1. Digital Documentation of Events: Capture quality events at the moment they occur, ensuring real-time accuracy and traceability. Immediate documentation is crucial for maintaining a clear and precise record of events, which is vital for compliance and quality assurance.
2. Automatic Creation of Events: Implement systems that automatically generate quality events when predefined limits are breached. This automation eliminates the need for manual oversight and guarantees that no critical event will be overlooked. The system also allows for quicker response times, as it can immediately alert relevant personnel.
3. Centralized Information: Maintain all relevant information in a single digital repository. This centralization streamlines access and management, making it easier for teams to collaborate and review documentation. It also ensures that all data is up-to-date and easily accessible, which is essential for audits and inspections.
4. Enhanced Review Process: Utilize digital tools to facilitate collaboration and ease the review process. By focusing on deviations and quality events, reviewers can quickly identify and address issues, improving overall efficiency. Digital tools can also provide analytics and reporting features, offering insights into trends and potential areas for improvement.

 

Low-code platforms are the solution for adapting digital solutions to specific processes and achieving a truly digitalized workflow. These platforms allow for rapid development and deployment of customized solutions, ensuring that the digital tools align perfectly with the unique needs of the manufacturing process.

Example: Consider a pharmaceutical manufacturing facility that transitions from paper-based to digital documentation. By implementing a low-code platform, the facility can set predefined limits for critical process parameters. When a parameter exceeds its limit, the system automatically generates a quality event, which is logged in a centralized digital repository. Reviewers can then focus on these events, using collaborative tools to ensure swift and accurate resolution.

1: Workflow of event creation

2: Example screen of application covering manual creation of an event

In this example, the digital solution not only streamlines the documentation process but also enhances the facility's ability to maintain compliance and ensure product quality. The automated generation of quality events eliminates the risk of human error, while the centralised repository and collaborative tools boost efficiency and communication.

Conclusion: Transforming to digital documentation and digitalized quality event handling not only enhances compliance and efficiency but also significantly reduces the risk of human error. By leveraging low-code platforms, pharmaceutical manufacturers can achieve a seamless, digitalized process that ensures quality and compliance at every step. This transformation is crucial for staying competitive in a rapidly evolving industry and meeting the stringent regulatory requirements.