Electronic Batch Record

Purpose of the Electronic Batch Record app suite

This app suite is a part of Tulip’s Composable MES for Pharma app suite. It follows the production of SolidX.
SolidX is a product whose manufacturing follows a process we designed, starting from material weighing, through blending, to tabletting, and finally packaging the tablets. The creation of these applications was guided by Tulip's best practices. The overall process is broken down into smaller steps or apps, based on the physical locations within the facility, ensuring that each step in the application closely aligns with the process itself and the personnel responsible for execution.

The app suite includes the following applications:

• Station Weighing – Responsible for weighing the materials used for each batch.
• Daily Sensitivity Test – Assists with and documents the daily calibration checks of the scales in use.
• Material Receipt – Creates a digital twin of materials received from the warehouse and stores it in the tables.
• Reconciliation – Ensures there are no discrepancies between the physical materials and their digital counterparts.
• Blending – Guides the operator through the process of preparing the powder mixture, ensuring the correct order of material blending.
• Blending Weight Check – Supports the execution of intermediate weight checks during the blending process.
• Tableting – Verifies the necessary settings on the tablet press machine and helps track time-sensitive tasks during tablet production.
• Tableting Weight Check - Eliminates the need for the operator to perform and verify calculations. After collecting the necessary data, the app automatically performs the calculations and, if any limits are exceeded, it generates a deviation report. This ensures accuracy and helps maintain quality control during the tableting process.

At this point, the first half of our process concludes. This is followed by a Batch Review app, which compiles all the events and recorded data from the production process. This ensures that the appropriate personnel can review and verify the information, providing a thorough quality check.

The other half of our process is packaging. For one process order, multiple batches may be possible, which is why there is a batch review app for this part as well. The packaging process includes the following apps:

• Packaging Line Changeover – Supports the setup of the packaging line.
• Packaging – Ensures that the correct materials are used in packaging, supports and documents sample collection, and reports downtime.
• Material Labeling – Helps with labeling the shipping boxes and continuously updates the quantity of finished products.

The app suite also includes apps that support and document in-process sampling and testing of the product during manufacturing.
These apps work together to streamline the manufacturing process from material handling to the final product.

Composable MES for Pharma is not only Library Apps, but also guidance on how to assemble those Apps to create your MES.

Tables

All the apps included in the app suite save data into tables based on the Tulip common data model.

Core Solution Design principles

When designing and building the applications, we adhered to the following key principles.

• The applications must be clear and easy to understand.
• Each app represents a specific process step that occurs in a defined physical environment and is performed by an operator.
• The primary goal of the apps is to support the operator’s tasks within that environment.

We embraced a Composable Architecture approach. Instead of building apps based on standard processes, our aim is to create reusable, modular, and easily adaptable apps that can be customized for specific products or use cases. This Composability allows for greater flexibility and scalability in various production environments, ensuring that each app evolves with operational needs.

This design methodology ensures that the apps are not only user-friendly but also highly efficient in supporting continuous improvement and quick adaptation to new scenarios.

In Tulip applications, tables serve as a structured framework for organizing and storing data, specifically representing both physical artifacts and operational artifacts. This setup is integral to ensuring efficient data management and facilitating application development.

This structured data management model enables the development of modular, reusable applications that can easily adapt to various operational needs.​

Concept of single-product App VS multi-product

Depending on the number of products that you are manufacturing, and the variance that it introduces into a specific unit of the process, you can choose to create Apps that are purpose-fit for a single product or that will need to handle more variability (e.g. equipments, materials, etc) and then be multi-product.

A multi-product App is best used when a process step is always the same, regardless of the product. For example, in a pharmaceutical cMES system, processes like station weighing and packaging fall under this category. In such cases, product-specific information is stored in tables or even external third-party software, with connectors used to transfer the necessary data.

For weighing, product-specific material lists are stored in the Material list table. For packaging, the SKU parameters table holds settings like temperature, equipment speed, camera configurations, and the pharma codes for packaging materials.

This approach ensures that when changes are needed, only one application has to be updated. It ultimately allows manufacturers to handle hundreds of product configurations within a single App and a few configuration Tables.

Single-product Apps, has product-specific parameters stored in the text, images, trigger logic of the application itself. This can be highly beneficial when the manufacturing processes for different products are not standardized and vary significantly. In these cases, single-product apps allow for more customization and flexibility.

This method can scale by basing all the individual Apps from a given process from a template. For example, if the blending process varies across product, you can base all your blending Apps on the blending template.

The advantage of single-product apps is that they do not require process standardization, which could be helpful in avoiding surprises or constraints when dealing with highly varied product workflows. However, this lack of standardization might also mean that updates or changes in one product do not automatically apply to others, adding complexity to the overall system.

By combining these two approaches—multi-product and single-product applications—companies can achieve the highest levels of flexibility and efficiency, while ensuring that product variations are handled seamlessly.

Routing between apps

In Tulip, users have the flexibility to create connections between different apps in whichever way best suits their needs. One option is using a batch tracking app — similar to the one we use in composible MES for pharma demo — that maps out the production process for a specific product and includes buttons to navigate between different process apps. This app essentially serves as a navigation hub.

However, the logic from this app can also be integrated directly into the beginning of the process applications themselves, making a separate navigation hub unnecessary. Another option is to structure the navigation by storing the required information in a table (for example, in the station table we use in the common data model) to handle app navigation.

Validation

The Station Weighing is a pre - validated app, meaning it comes with a risk analysis and test scripts included.

Options for connecting the app with other applications

Batch Production Management

The apps within the Batch Production management app suite use the data generated by the various applications of the eBR app suite to provide a real-time picture of what is happening in the plant through reports and dashboards.

References

• Composable MES for Pharma
• Batch Production Management app suite
• Common Data Model for Pharma
• Blending App Group
• Tableting App Group
• Packaging App Group
• eBR Review App Group
• Weigh and Dispense App Group
• Sampling & IPC App Group