Risk-Based Worst Case Identification Calculator

Risk-Based Worst Case Identification Calculator

  • Purpose: This calculator helps identify the worst case product for cleaning validation using a structured risk-based scoring approach aligned with EMA HBEL (2014), PIC/S PI 006, and WHO TRS 1019 principles. It ranks products based on toxicity, dose, solubility, batch size, and operational risk factors.
  • Enter the Product Name clearly for identification and documentation purposes.
  • Enter PDE (mg/day) of each product. Lower PDE values indicate higher toxicity and increase risk ranking.
  • Enter Maximum Daily Dose (mg/day). This must be the maximum therapeutic daily dose per patient, not unit strength. Lower daily dose increases carryover risk.
  • Enter Solubility (mg/mL) in the selected cleaning solvent. Lower solubility increases cleaning difficulty and risk score.
  • Enter Batch Size (kg). Always use mass (kg) for consistency across products. For injectables, convert liters to kg using density where applicable.
  • Select Cleaning Difficulty (1–5) based on practical experience:
    • 1 = Easy to clean
    • 3 = Moderate difficulty
    • 5 = Very difficult to clean / sticky / potent residue
  • Select Equipment Complexity (1–5) based on equipment design:
    • 1 = Simple equipment with easy access
    • 3 = Moderate complexity
    • 5 = Complex equipment with hard-to-clean areas
  • Use ＋ Add Product to include additional products for comparison.
  • Click Calculate to generate risk ranking and identify the worst case product.
  • The calculator applies weighted scoring:
    • Toxicity (PDE) – 30%
    • Maximum Daily Dose – 20%
    • Solubility – 15%
    • Batch Size – 10%
    • Cleaning Difficulty – 15%
    • Equipment Complexity – 10%
  • The product with the highest overall risk score is identified as the Worst Case Product.
  • Use Show Detailed Calculation to view scoring transparency.
  • Use Print / Save as PDF to generate documentation for cleaning validation risk assessment reports.
  • Note: Final worst case justification must be documented in the official cleaning validation risk assessment report and supported by scientific rationale.
Product PDE
(mg/day)		 Maximum
Daily Dose
(mg/day)		 Solubility
(mg/mL)		 Batch Size
(kg)		 Cleaning
Difficulty
(1-5)		 Equipment
Complexity
(1-5)		 Action
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