Unit of competency Outline

Date retreived
22/07/2026 7:02 AM AWST

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Clean and sanitise facilities and equipment

Clean and sanitise facilities and equipment

Unit of competency
National Code
FBPPHM3004
State Code
OAM67
TGA Status
Current
DTWD Status
Approved
Current Release Number
1.00
Current Release Date
18/12/2018
View on TGA
State Implementation and Classification
Approved Date
18/04/2019
Field of Education
030717 - Plant And Machine Operations
Original Release Date
18/04/2019
Nominal Hours
25
Description
This unit of competency describes the skills and knowledge required to plan, prepare, clean and sanitise processing facilities and equipment in a pharmaceutical manufacturing facility.The unit applies to individuals who apply Good Manufacturing Practice (GMP) requirements and operating principles to the cleaning and sanitising of facilities and equipment. Individuals work under broad direction and take responsibility for their own work. No occupational licensing, legislative or certification requirements apply to this unit at the time of publication.
Notes
Elements and Performance Criteria
1. Plan and prepare to clean pharmaceutical processing areas and equipment
  • 1.1 Obtain cleaning task requirements, including job specifications and workplace procedures for sampling and testing cleaning outcomes
  • 1.2 Identify surfaces and soil and dirt types and select appropriate cleaning techniques
  • 1.3 Select and prepare cleaning chemicals required for job
  • 1.4 Select and check cleaning equipment and consumables for serviceability and compliance with cleaning and sanitation requirements of GMP cleaning program
  • 1.5 Rectify or report faults before starting work
  • 1.6 Confirm services are available and ready for operation
  • 1.7 Source and fit personal protective equipment (PPE) according to procedures for health and safety in the workplace
  • 1.8 Obtain cleaning consumables to meet anticipated usage patterns
  • 1.9 Select and install signs and barricades according workplace procedures
  • 1.10 Set the plant for automated cleaning cycle or initiate a manual clean
2. Remove waste
  • 2.1 Collect and dispose of waste according to procedures and legislative requirements for the environment and health and safety in the workplace
  • 2.2 Clean and sanitise rubbish bins and insert new replacement bin liners according to workplace procedures
3. Clean and sanitise pharmaceutical processing surfaces
  • 3.1 Change status label of area and equipment and check status prior to cleaning
  • 3.2 Remove loose dirt and debris from pharmaceutical processing surfaces prior to applying cleaning treatment
  • 3.3 Follow cleaning steps according to workplace procedures
  • 3.4 Apply cleaning chemicals to pharmaceutical surfaces according to manufacturers' specifications and workplace procedures
  • 3.5 Thoroughly rinse and dry surfaces according to workplace procedures
  • 3.6 Apply chemical disinfectants and sanitisers to surfaces according to workplace procedures
  • 3.7 Report practices inconsistent with GMP according to workplace procedures
4. Clean and sanitise pharmaceutical processing equipment
  • 4.1 Clean and sanitise processing equipment according to GMP requirements and workplace procedures
  • 4.2 Monitor the cleaning process and identify and report deviations from job specifications according to workplace procedures
  • 4.3 Inspect and confirm equipment cleanliness status against acceptance criteria and take appropriate action to rectify non-conformances
  • 4.4 Confirm relevant sampling or testing methods including sampling or testing points, types of samples and measurements requirements
  • 4.5 Take, collect, store and transport samples according to sampling plan, relevant methods and standards
  • 4.6 Return equipment to operating order
  • 4.7 Record and certify data and information about equipment cleaning and sanitising, including cleaning status, sampling and testing according to workplace procedures and GMP requirements
5. Return plant to operating condition
  • 5.1 Remove signs and barricades according to workplace procedures and work health and safety
  • 5.2 Clean, check and store cleaning equipment and PPE according to manufacturers' specifications, environmental and workplace health and safety requirements
  • 5.3 Store and dispose of unused chemicals according to manufacturers' specifications, and workplace health and safety requirements
  • 5.4 Order and replenish cleaning consumables
  • 5.5 Document tasks completed according to workplace procedures
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