Biomanufacturing Cleanroom Contamination Loss Calculator

Quantify the cost of a cleanroom contamination event by combining lost batches, per-batch revenue, remediation downtime, and daily cleanup costs. Adjust the optional breakeven percentage to communicate how much preventive monitoring, training, or automation spend is justifiable to avoid a single incident.

Number of production batches scrapped after a contamination event, including partial batches.
Gross revenue attributable to each finished batch at list price or transfer price.
Average downtime days required for remediation, cleaning, and validation before restart.
Direct cost of idle labor, testing, disposal, and lost capacity per downtime day.
Optional — defaults to 25%. Adjust to match the loss percentage leadership is willing to invest in prevention.

Actual contamination losses depend on product mix, regulatory response, and insurance coverage. Validate assumptions with your operations, quality, and finance teams.

Examples

  • Example 1 — 2 batches lost, $420,000.00 revenue per batch, 4 downtime days, $35,000.00 remediation cost, 25% breakeven ⇒ Incident revenue at risk: $840,000.00 | Downtime remediation cost: $140,000.00 | Total loss per incident: $980,000.00 | Prevention spend breakeven (25.00% of loss): $245,000.00
  • Example 2 — 1.5 batches lost, $310,000.00 per batch, 6 downtime days, $28,000.00 remediation, 30% breakeven ⇒ Incident revenue at risk: $465,000.00 | Downtime remediation cost: $168,000.00 | Total loss per incident: $633,000.00 | Prevention spend breakeven (30.00% of loss): $189,900.00

FAQ

How do I handle partial batches?

Enter fractional batch counts for partial production runs so the calculator scales revenue loss proportionally.

Can insurance offset part of the loss?

Yes. After estimating insured recoveries, subtract them from the total loss output to see the remaining exposure you need to mitigate internally.

Where should probability of occurrence fit?

Multiply the total loss output by your estimated incident probability to derive an expected loss figure for annual planning or risk registers.

Does this include regulatory penalties?

No. Add expected penalties, recall costs, or contract damages to the remediation input or stack them on top of the total loss output when presenting risk scenarios.

Additional Information

  • Revenue at risk multiplies the number of lost batches by their gross revenue contribution.
  • Downtime cost covers remediation labor, QC testing, waste disposal, and validation activities per day.
  • Total loss per incident sums revenue at risk and downtime cost to frame the exposure.
  • Prevention breakeven applies a chosen percentage to benchmark investments in monitoring, automation, or redundancy.
  • Adjusting the breakeven percentage helps align capital requests with leadership risk tolerance and quality objectives.

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