During the manufacturing of biopharmaceutical products, various intermediate materials are created and may be tested prior to continuing the manufacturing process. These generally exist temporarily until they are used in subsequent steps in the process. For example, when manufacturing solid tablets, the process may first blend all active and inactive ingredients. This blend is an intermediate product. The blend is then additionally processed to produce the final tablet form.
Samples of intermediate products are often collected and analyzed for specific characteristics before using that material in subsequent manufacturing steps. Testing of intermediate materials is similar to the testing of final product materials, although typically test results for intermediates are used to verify or adjust the manufacturing process and would not be treated as release criteria.
Defining Process Intermediates for a Product
In Vault LIMS, intermediate materials are represented by Material object records of the Intermediate object type. These records are related to Base Material object records via the special Process Intermediate relationship type.
Just like a final product, intermediate materials have their own Lab Specifications, Lab Protocols, and Lab Methods which drive automated creation of Lab Tests. When a Batch record is created for the final product, it triggers the creation of Lab Tests to perform against that final product, and Vault LIMS also creates Batches and Lab Tests for that product’s Process Intermediates.
Adding Process Intermediates to a Material
Before relating an intermediate material to a final product material, set up its static data. Once it is set up, you can add it to the base material:
- On a Material object record of the Base Material type, navigate to the Process Intermediates section and click Create.
- Select Process Intermediate in the Relationship Type drop-down.
- Select your intermediate material in the Related Material field.
- Click Save.