Unit of competency Outline

Date retreived
22/07/2026 4:44 PM AWST

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Operate a chromatography manufacturing process

Operate a chromatography manufacturing process

Unit of competency
National Code
FBPPHM3019
State Code
OCW24
TGA Status
Current
DTWD Status
Approved
Current Release Number
1.00
Current Release Date
21/01/2021
View on TGA
State Implementation and Classification
Approved Date
29/03/2021
Field of Education
030717 - Plant And Machine Operations
Original Release Date
29/03/2021
Nominal Hours
60
Description
This unit of competency describes the skills and knowledge required to set up, operate, adjust and shut down a chromatography separation process in a pharmaceutical manufacturing facility.The unit applies to individuals who use Good Manufacturing Practice (GMP) and operating principles in the chromatography separation process. Individuals work under broad direction and take responsibility for their own work.No licensing, legislative or certification requirements apply to this unit at the time of publication.
Notes
Elements and Performance Criteria
1. Prepare chromatography equipment for operation
  • 1.1 Identify production requirements from workplace documentation
  • 1.2 Confirm materials meet production requirements
  • 1.3 Confirm required facilities, storage, equipment and personnel are available
  • 1.4 Select and fit personal protective equipment and contamination prevention clothing according to workplace procedures
  • 1.5 Clean, assemble and adjust equipment according to workplace procedures and operation and maintenance manual
  • 1.6 Set equipment components and related instrumentation to meet production requirements
  • 1.7 Conduct pre-start checks according to workplace procedures
  • 1.8 Complete equipment status reports according to workplace procedures
2. Prepare samples and load products
  • 2.1 Conduct pre-sampling tests and interpret test results to confirm process operation
  • 2.2 Identify and report out of limit test results according to workplace procedures
  • 2.3 Load product and pack into columns according to specifications and production requirements
3. Operate and monitor separation process
  • 3.1 Start up and monitor separation process to confirm process cycles occur in correct sequence according to specifications and production requirements
  • 3.2 Identify and report out of limit products or processes according to workplace procedures
  • 3.3 Confirm separation of solution meets specifications
  • 3.4 Conduct process according to safety and environmental requirements
  • 3.5 Complete documentation according to workplace requirements
4. Shut down separation process
  • 4.1 Confirm isolation and lock out procedures and product and process changeovers for shutting down
  • 4.2 Safely shut down process
  • 4.3 Clean work area according to workplace procedures
  • 4.4 Complete records according to workplace procedures
No information
No information
Replaces
State Code National Code Title Type
OAM81 FBPPHM3007 Operate a separation process using chromatography Unit of competency