🇦🇺Australia

Sterilisation Failure Rework Costs

2 verified sources

Definition

Failed validation leads to infection risks, requiring rework of batches, warranty claims, and potential regulatory audits. Standards mandate full process validation to prevent contamination.

Key Findings

  • Financial Impact: AUD 5,000-50,000 per batch rework + compensation; 2-5% production loss from idle equipment during revalidation
  • Frequency: Per failed cycle or audit finding
  • Root Cause: Incomplete annual reviews, unvalidated changes, offsite servicing without proper re-qualification

Why This Matters

The Pitch: Medical equipment manufacturers in Australia 🇦🇺 incur AUD 20,000+ per incident in rework and claims from sterilisation validation gaps. Automated validation ensures 100% compliance.

Affected Stakeholders

Production Manager, QA Team, Compliance Officer

Deep Analysis (Premium)

Financial Impact

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Current Workarounds

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Methodology & Sources

Data collected via OSINT from regulatory filings, industry audits, and verified case studies.

Evidence Sources:

Related Business Risks

Sterilisation Validation Non-Compliance Fines

AUD 10,000+ per incident in penalties and lost accreditation revenue; annual validation downtime 20-40 hours per steriliser

Annual Validation Labour Overruns

20-40 hours per steriliser annually at AUD 100-150/hour specialist labour (total AUD 2,000-6,000 per unit)

Rework from CAPA Delays

AUD 5,000 - 20,000 per major CAPA event in rework costs; 2-5% production scrap increase

TGA CAPA Non-Compliance Fines

AUD 20,000 - 100,000 per TGA enforcement action; 100-500 hours per CAPA audit remediation

Bußgelder wegen verspäteter Meldung von Vorkommnissen an die TGA

Logic-based estimate: AUD 50,000–150,000 per significant late or missed MDR case in combined legal, internal investigation, consultant, and recall-preparation costs; plus risk of additional civil penalties set under the Therapeutic Goods Act 1989.

Überhöhte interne Kosten für manuelle Bearbeitung von Beschwerden und MDR‑Bewertungen

Logic-based estimate: AUD 800–1,800 internal labour cost per escalated or potentially reportable complaint; equating to roughly AUD 120,000–540,000 annually for 150–300 such complaints at a mid‑size manufacturer.

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