Competency information
Details
Perform a range of environmental monitoring procedures, including physical and microbiological techniques.
Considerations
- How you would devise an environmental monitoring programme.
- Validation of sterility testing, positive and negative controls, local procedures.
- Difference between microbiology in clinical and pharmaceutical microbiology.
- Sampling sizes for microbial monitoring – air sampling/sterility test, etc.
- Endotoxin and pyrogen testing.
- Pharmaceutical microbiology – sterility testing, non-sterile product microbiology, water systems testing, preservative efficacy testing.
- Sample handling.
Relevant learning outcomes
| # | Outcome |
|---|---|
| # 4 | Outcome Perform a range of microbiological techniques to assist in providing evidence of product and facility compliance and analyse, interpret and report the test results. |