home / skills / a5c-ai / babysitter / sterilization-validation-planner
This skill helps plan and validate sterilization processes across EO, radiation, and steam by guiding method selection, dosing, and protocol generation.
npx playbooks add skill a5c-ai/babysitter --skill sterilization-validation-plannerReview the files below or copy the command above to add this skill to your agents.
---
name: sterilization-validation-planner
description: Sterilization process validation planning skill for EO, radiation, and steam sterilization
allowed-tools:
- Read
- Write
- Glob
- Grep
- Edit
- Bash
metadata:
specialization: biomedical-engineering
domain: science
category: Sterilization and Manufacturing
skill-id: BME-SK-026
---
# Sterilization Validation Planner Skill
## Purpose
The Sterilization Validation Planner Skill supports sterilization process development and validation for medical devices, ensuring sterility assurance levels per ISO standards and FDA guidance.
## Capabilities
- Sterilization method selection guidance
- Bioburden determination protocol
- Dose setting (ISO 11137) or half-cycle development
- IQ/OQ/PQ protocol templates
- Sterility test requirements
- Parametric release guidance
- Revalidation scheduling
- Material compatibility assessment
- Biological indicator selection
- Process challenge device design
- Dose audit planning
## Usage Guidelines
### When to Use
- Selecting sterilization methods
- Planning validation activities
- Developing validation protocols
- Establishing revalidation programs
### Prerequisites
- Product materials characterized
- Packaging system defined
- Bioburden data available
- Sterilization facility identified
### Best Practices
- Select method based on material compatibility
- Validate worst-case configurations
- Plan for ongoing process monitoring
- Document all parameters thoroughly
## Process Integration
This skill integrates with the following processes:
- Sterilization Validation
- Sterile Barrier System Validation
- Design for Manufacturing and Assembly (DFMA)
- Design Control Process Implementation
## Dependencies
- ISO 11135 (EO)
- ISO 11137 (radiation)
- ISO 17665 (steam)
- AAMI standards
- Sterilization service providers
## Configuration
```yaml
sterilization-validation-planner:
methods:
- ethylene-oxide
- gamma-radiation
- e-beam
- steam
- dry-heat
validation-phases:
- IQ
- OQ
- PQ
sal-targets:
- 10-3
- 10-6
```
## Output Artifacts
- Method selection rationale
- Bioburden protocols
- Dose setting reports
- IQ/OQ/PQ protocols
- Validation reports
- Parametric release procedures
- Revalidation schedules
- Monitoring plans
## Quality Criteria
- Method appropriate for product
- SAL target achieved
- Validation protocols comprehensive
- Material compatibility verified
- Parametric release justified
- Revalidation program established
This skill supports planning and documenting sterilization process validation for ethylene oxide (EO), radiation, and steam methods. It guides method selection, dose or cycle development, and produces validation artifacts aligned with ISO and FDA expectations. The output focuses on practical deliverables you can use in regulatory filings and supplier conversations.
The skill inspects product and packaging inputs (materials, bioburden data, and worst-case configurations) to recommend an appropriate sterilization method and SAL target. It generates protocols for IQ/OQ/PQ, bioburden testing plans, dose-setting or half-cycle development steps, and parametric release guidance. It also creates revalidation schedules, material compatibility checks, and process-challenge device designs to support the full validation lifecycle.
Does the skill replace standards like ISO 11137 or ISO 17665?
No. The skill uses those standards as references and helps produce compliance-focused artifacts, but users must follow the full standard texts and regulatory guidance.
What inputs are required to generate a valid plan?
You should provide product materials, packaging design, representative bioburden data, intended sterilization method candidates, and any facility constraints or supplier capabilities.