Competency information
Details
Interpret an autoclave chart. Critically appraise previous validations, e.g. container/closures, sterilisers.
Considerations
- Importance of cleaning validation and the use of cleaning procedures.
- Risks associated with cross-contamination and carry-over limits.
- Product characteristics and specific cleaning considerations.
- Requirements for monitoring sterilisation logs.
- Importance of trend analysis and early warning of potential issues.
- Process validation as outlined in EU Good Manufacturing Practice and other texts.
- Thermometric validation.
- Dosimeter validation.
- Biological indicator validation.
Relevant learning outcomes
| # | Outcome |
|---|---|
| # 4 | Outcome Perform all manufacturing activities in accordance with requirements for EU Good Manufacturing Practice and pharmaceutical management quality systems. |