Electronic Batch Record App Suite

The Electronic Batch Record(eBR) app suite is a part of Tulip’s Composable MES for Pharma. It follows the production of SolidX, starting from material weighing, through blending, to tabletting, and finally packaging the tablets.
These applications follow GxP best practices. The overall process is broken down into smaller steps or apps, based on the physical locations within the facility. This separation aligns each step with a specific process and the personnel responsible for execution.

The eBR app suite includes the following applications:

• Station Weighing – Weighs the materials used for each batch.
• Daily Sensitivity Test – Documents and assists with daily calibration checks of the scales in use.
• Material Receipt – Creates a digital twin of materials received from the warehouse and stores it in 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, to ensure 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.

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 includes guidance on how to assemble the apps to work as a whole MES.

Tables

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

In Tulip applications, tables serve as a structured framework for organizing and storing data, specifically representing both physical artifacts and operational artifacts. This structured data management model enables the development of modular, reusable applications that can easily adapt to various operational needs.​

Core Solution Design

The Electronic Batch Record App Suite uses the following key principles:

• Each app is 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 goal of the apps supports the operator’s tasks within each environment.

Single-product vs. Multi-product apps

Depending on the number of products that you are manufacturing and the variance introduced into a specific unit of the process, you can choose to create apps that are purpose-fit for a single product or that need to be fit for multiple products.

The cMES for Pharma contains both types of apps.

By combining multi-product and single-product applications you can achieve flexibility and efficiency, while ensuring that product variations are handled seamlessly.

Single-product app

Single-product Apps have 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.

Single-product apps in the cMES for Pharma include:

• Blending app group
• Tableting app group

Single-product apps do not require process standardization, which avoids surprises and constraints when dealing with highly varied product workflows. However, this lack of standardization means that updates or changes in one product do not automatically apply to others.

Multi-product app

Multi-product App is best used when a process step is always the same, regardless of the product. Product-specific information is stored in tables, or even external third-party software that transfers data through Connectors.

Multi-product apps in the cMES for Pharma include:

• Weigh and Dispense App Group
• Sampling & IPC App Group
• eBR Review App Group
• Packaging App Group

Multi-product apps ensure that when changes are needed, only one application has to be updated. It allows manufacturers to handle hundreds of product configurations with a single app and a few tables.

Routing between apps

In Tulip, users have the flexibility to create connections to route between different apps. Here are options for these connections:

• Use a batch tracking app that maps out the production process for a specific product. This app would serve as a navigation hub and include buttons to navigate between different process apps.
• Create a navigation step at the beginning of each process application.
• Structure the navigation by storing the required information in a table (within a 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.

Connect 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
• Electronic Logbook
• Common Data Model for Pharma