Scale-up, Batch & Fill Calculator
Calculate linear batch scale, process allowance, fill bulk, and potency-corrected material quantity.
Scale-up, batch & fill results
Choose a mode and enter values.
This performs linear scaling only for the same formulation and conserved basis. New mixing, hold-time, surface-to-volume, transfer-loss, and control-strategy effects at scale require separate development and validation.
Sources: ICH Q7; FDA Allowable Excess Volume and Labeled Vial Fill Size guidance; ICH Q8/Q9/Q10 implementation considerations.
Tool Guide
Definition
Scale-up, Batch & Fill Calculator — Batch Scale mode calculates a linear scale factor plus theoretical component and process-allowance quantities from reference and target batches. Fill Plan mode calculates nominal and planned bulk from container count, fill volume, and strength, keeps bulk allowance separate from active overage, and corrects raw-material quantity for potency.
Purpose
(1) Cross-check component quantities between development and manufacturing batches (2) Derive nominal and planned bulk for a target container count (3) Separate fill or transfer-loss allowance from active overage (4) Calculate weigh quantity using raw-material assay potency
How to Use
① Choose Batch Scale or Fill Plan mode. ② For Scale, enter reference and target batch size, component amount, and process allowance. ③ For Fill, enter container count, fill volume per container, target strength, bulk allowance, active overage, and potency. ④ Cross-check the results against the draft batch record. Linear scaling assumes the same formulation and basis. Active overage is not automatically approved and requires product-specific justification plus quality and regulatory review.
Examples
Scale example) Reference batch=10, target=50, component=2 g, allowance=5% → factor=5×, theoretical=10 g, planned=10.5 g Fill example) 1,000 containers × 2 mL, 5 mg/mL, bulk allowance=10%, active overage=2%, potency=95% → planned bulk=2,200 mL=1,100 equivalent units → active at target strength=11,000 mg, planned active=11,220 mg → potency-corrected material=11,810.5263 mg Process suitability and overage acceptability are not decided automatically.