Elements and Performance Criteria
- Plan and prepare to clean pharmaceutical processing areas and equipment
- Obtain cleaning task requirements, including job specifications and workplace procedures for sampling and testing cleaning outcomes
- Identify surfaces and soil and dirt types and select appropriate cleaning techniques
- Select and prepare cleaning chemicals required for job
- Select and check cleaning equipment and consumables for serviceability and compliance with cleaning and sanitation requirements of GMP cleaning program
- Rectify or report faults before starting work
- Confirm services are available and ready for operation
- Source and fit personal protective equipment (PPE) according to procedures for health and safety in the workplace
- Obtain cleaning consumables to meet anticipated usage patterns
- Select and install signs and barricades according workplace procedures
- Set the plant for automated cleaning cycle or initiate a manual clean
- Remove waste
- Clean and sanitise pharmaceutical processing surfaces
- Change status label of area and equipment and check status prior to cleaning
- Remove loose dirt and debris from pharmaceutical processing surfaces prior to applying cleaning treatment
- Follow cleaning steps according to workplace procedures
- Apply cleaning chemicals to pharmaceutical surfaces according to manufacturers' specifications and workplace procedures
- Thoroughly rinse and dry surfaces according to workplace procedures
- Apply chemical disinfectants and sanitisers to surfaces according to workplace procedures
- Report practices inconsistent with GMP according to workplace procedures
- Clean and sanitise pharmaceutical processing equipment
- Clean and sanitise processing equipment according to GMP requirements and workplace procedures
- Monitor the cleaning process and identify and report deviations from job specifications according to workplace procedures
- Inspect and confirm equipment cleanliness status against acceptance criteria and take appropriate action to rectify non-conformances
- Confirm relevant sampling or testing methods including sampling or testing points, types of samples and measurements requirements
- Take, collect, store and transport samples according to sampling plan, relevant methods and standards
- Return equipment to operating order
- Record and certify data and information about equipment cleaning and sanitising, including cleaning status, sampling and testing according to workplace procedures and GMP requirements
- Return plant to operating condition
- Remove signs and barricades according to workplace procedures and work health and safety
- Clean, check and store cleaning equipment and PPE according to manufacturers' specifications, environmental and workplace health and safety requirements
- Store and dispose of unused chemicals according to manufacturers' specifications, and workplace health and safety requirements
- Order and replenish cleaning consumables
- Document tasks completed according to workplace procedures