MedTech Manufacturing worked example

Validation Batch Cost with validation batch size of 150 devices: a worked example in medtech manufacturing

This worked example runs the validation batch cost numbers for a tougher week than the baseline: validation batch size of 150 devices instead of the typical 300 devices. Estimate the total cost of a process validation (PQ) batch including material, labor, extended testing, and documentation.

The inputs for this scenario

  • Validation batch size: 150 devices (the input this scenario stresses; the baseline uses 300)
  • Variable cost per device (validation): 22 $ / device (held at the documented default)
  • Fixed validation costs: 8,500 $ (held at the documented default)
  • Additional testing and documentation labor: 4,200 $ (held at the documented default)

Working through the calculation

  • The calculation starts from the formula this tool documents: Total validation batch cost = validation batch size × variable cost per device + fixed validation costs + additional testing and documentation labor.
  • Total PQ batch cost works out to 16,000 $ at these inputs, and this is the headline figure for the scenario.
  • Validation cost per device works out to 107 $ / piece at these inputs.
  • Total material and direct labor works out to 3,300 $ at these inputs.
  • Fixed validation and testing costs works out to 12,700 $ at these inputs.

How this compares with the baseline

  • Against the tool's baseline example, where validation batch size sits at 300 devices and the headline result is 19,300 $, this scenario comes in 17.1% below the baseline at 16,000 $.
  • Use it when budgeting a PQ or process validation batch, or estimating the cost impact of a change that requires re-validation. A result at this level usually justifies acting on the stressed input before touching anything else, because every other figure in the table is downstream of it.

Results at a glance

  • Total PQ batch cost: 16,000 $ (headline result)
  • Validation cost per device: 107 $ / piece
  • Total material and direct labor: 3,300 $
  • Fixed validation and testing costs: 12,700 $

Run it with your numbers

  • To rerun this with your own numbers, open the live Validation Batch Cost calculator, set validation batch size to your actual value, and adjust the remaining inputs to match your operation.

Last reviewed 2026-05-12.