Elements and Performance Criteria
- Prepare to enter a controlled environment
- Obtain workplace information, including workplace procedures related to working in a controlled environment
- Remove jewellery and makeup according to workplace procedures
- Wash hands according to workplace procedures
- Source and fit personal protective equipment (PPE) and contamination prevention clothing prior to entering controlled environment
- Check controlled environment operating conditions prior to entry
- Work in a controlled environment
- Maintain a controlled environment
- Identify controlled environment contamination risks
- Control environmental contamination according to GMP requirements and workplace procedures
- Maintain controlled environment work area according to workplace cleaning standards and environmental requirements
- Report practices inconsistent with GMP according to workplace procedures
- Exit a controlled environment
- Follow workplace procedures to exit a controlled environment
- Remove PPE and contamination prevention clothing according to workplace procedures
- De-gown according to workplace procedures
- Check, store and dispose of PPE according to manufacturer specifications, environmental and work health and safety requirements