Governing Equations

Contamination Probability (per vial):
  P(c) = 1 - exp(-λ)
  where λ = baseline_rate + intervention_rate

Grade A Limits (ISO 5):
  ≥0.5μm: ≤ 3,520 particles/m³
  ≥5.0μm: ≤ 29 particles/m³

Grade B (ISO 7 at rest, ISO 5 in operation):
  ≥0.5μm: ≤ 352,000 particles/m³

Media Fill Acceptance:
  ≤ 1 positive in 3,000 units → pass
  Sterility Assurance Level (SAL): 10⁻⁶

Poisson Distribution:
  P(x) = (λˣ · e⁻ˡ) / x!

Operator Intervention Impact:
  Δλ = interventions × 0.001 × (grade_factor)
  grade_factor: A=1, B=10, C=100