Unit of competency Outline

Date retreived
23/07/2026 12:10 AM AWST

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Work in a controlled environment

Work in a controlled environment

Unit of competency
National Code
FBPPHM3003
State Code
OAN23
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
061301 - Occupational Health And Safety
Original Release Date
18/04/2019
Nominal Hours
55
Description
This unit of competency describes the skills and knowledge required to prepare to enter, work and exit a controlled environment in a pharmaceutical manufacturing facility.The unit applies to individuals who apply Good Manufacturing Practice (GMP) requirements and operating principles to working in a controlled environment. 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. Prepare to enter a controlled environment
  • 1.1 Obtain workplace information, including workplace procedures related to working in a controlled environment
  • 1.2 Remove jewellery and makeup according to workplace procedures
  • 1.3 Wash hands according to workplace procedures
  • 1.4 Source and fit personal protective equipment (PPE) and contamination prevention clothing prior to entering controlled environment
  • 1.5 Check controlled environment operating conditions prior to entry
2. Work in a controlled environment
  • 2.1 Enter controlled environment according to workplace procedures
  • 2.2 Take commodity items into the controlled environment according to workplace procedures
  • 2.3 Conduct work activities to minimise risk of contamination
3. Maintain a controlled environment
  • 3.1 Identify controlled environment contamination risks
  • 3.2 Control environmental contamination according to GMP requirements and workplace procedures
  • 3.3 Maintain controlled environment work area according to workplace cleaning standards and environmental requirements
  • 3.4 Report practices inconsistent with GMP according to workplace procedures
4. Exit a controlled environment
  • 4.1 Follow workplace procedures to exit a controlled environment
  • 4.2 Remove PPE and contamination prevention clothing according to workplace procedures
  • 4.3 De-gown according to workplace procedures
  • 4.4 Check, store and dispose of PPE according to manufacturer specifications, environmental and work health and safety requirements
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