Unit of competency Outline

Date retreived
23/07/2026 4:43 AM AWST

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Operate a sterilisation process using an autoclave

Operate a sterilisation process using an autoclave

Unit of competency
National Code
FBPPHM3016
State Code
OAN61
TGA Status
Replaced
DTWD Status
Replaced
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
60
Description
This unit of competency describes the skills and knowledge required to set up, operate, adjust and shut down a sterilisation process using an autoclave in a pharmaceutical manufacturing facility.The unit applies to individuals who apply Good Manufacturing Practice (GMP) and operating principles to the sterilisation process using an autoclave. 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 equipment and process for operation
  • 1.1 Confirm autoclave and wrapping, cleaning and material items are available and meet load pattern requirements
  • 1.2 Prepare autoclave and position load probe according to load pattern requirements and standard operating procedure
  • 1.3 Enter operating parameters according to safety and sterilisation requirements
  • 1.4 Conduct pre-start checks according to workplace requirements
  • 1.5 Load wrapping, cleaning and material items according to load pattern requirements
2. Operate autoclave to terminally sterilise items
  • 2.1 Start up and monitor autoclave to confirm specifications are within required limits
  • 2.2 Identify and report out of limit materials or processes according to workplace procedures
  • 2.3 Maintain work area according to workplace cleaning standards
  • 2.4 Conduct process according to safety and environmental requirements
  • 2.5 Complete documentation according to workplace procedures
3. Remove items and follow shut down procedures
  • 3.1 Confirm the workplace procedures for shutting down the process
  • 3.2 Safely shut down the process
  • 3.3 Remove items from autoclave
  • 3.4 Check chemical indication to confirm items are dry
  • 3.5 Ensure segregation of sterile and non-sterile items
  • 3.6 Complete records according to workplace procedures
No information
No information
Replaces
State Code National Code Title Type
D4689 FDFPH2014A Operate a terminal sterilisation process Unit of competency
Replaced By
State Code National Code Title Type
OCW17 FBPPHM3018 Operate a sterilisation process using an autoclave Unit of competency
State Code National Code Title Type
BEF7 FBP30818 Certificate III in Pharmaceutical Manufacturing Qualification