26 Constructing Batch Sheets For Scale-Up
What is a Batch Sheet?
It is a document used in plants to monitor processes to ensure that the process is being carried out correctly. A batch sheet is the documentation used to explain if a process does not go as planned.
Purpose
An SOP provides detailed instructions for a process. Batch Sheets are needed to record exactly what happened during the process. A process rarely goes exactly as planned. Ingredient weights may be off of the formula weights slightly. Equipment conditions, speeds, temperatures, etc. can vary based on batch size or the given day of operation. The batch sheets are the first documents to be reviewed if the finished product does not meet specifications, so the detail and accuracy of the batch sheets are very important.
Method
- For each step or unit operation in your process (consult your up-to-date flow diagram), there should be a section in your batch sheet to document the step or unit operation parameters.
- Your process may need multiple batch sheets depending on the steps and what needs to be monitored.
- Below is a general batch sheet. Construct your batch sheet(s) based on your process and be as specific as possible. In addition to the columns below, you may also need to include data such as time, temperature, pH, RPMs, flow rates, throughput rates, the weight of rework, etc.
- Faculty will need to approve your batch sheet(s) before scale-up.
- The completed batch sheet(s) with all the details of scale-up recorded will be submitted.
| Unit Operation | Ingredient | Formula Weight (units) | Actual Weight (units) | Equipment & Conditions | Process Specification | Unit Operation Conclusion, including any variation from your SOP |
