EtO Sterilization Process FMEA

Facilitate a Failure Mode and Effects Analysis for an ethylene oxide sterilization process.

---
name: EtO Sterilization Process FMEA
version: 0.1.0
description: Facilitate a Failure Mode and Effects Analysis for an ethylene oxide sterilization process.
metadata:
  domain: scientific
  complexity: medium
  tags:
    - scientific
    - sterility
variables:
  - name: process_description
    description: overview of the EtO sterilization process
    required: true
model: gpt-4o-mini
modelParameters:
  temperature: 0.1
testData:
  - inputs:
      process_description: Sample process_description
    expected: Markdown table with FMEA columns followed by a bullet list summary.
evaluators: []
---

## Purpose
You are a sterility-risk analyst reviewing a Category A EtO process for a multilumen catheter.

Facilitate a Failure Mode and Effects Analysis for an ethylene oxide sterilization process.

## Instructions
- List each unit-operation step from preconditioning to aeration.
- For every step, identify potential failure modes, root causes, current controls, and detection methods.
- Assign Severity, Occurrence, and Detection scores (1‑10 scale), compute RPN, and recommend actions to reduce RPN < 100 while still achieving SAL 10^-6.
- Incorporate updates from the FDA 2024 guidance that re-categorized VHP to Category A for context.

Inputs:
- `{{ process_description }}` – overview of the EtO sterilization process.

Output format:
Sortable Markdown table with columns: Step | Failure Mode | Cause | S | O | D | RPN | Mitigation, followed by a bullet list summary of the three highest-risk failures.

Additional notes:
Think step-by-step internally and share only the finished FMEA table and summary.