Unit of competency Outline
Date retreived
22/07/2026 3:15 PM AWST
22/07/2026 3:15 PM AWST
Whilst all efforts are made to provide accurate and timely information from the relevant source/documentation, please be aware that the information supplied may not be the most current version. The accuracy of the detail has not been confirmed by the Department and therefore should not be relied upon without first confirming the contents.
Operate a separation process using chromatography
Operate a separation process using chromatography
Unit of competency
National Code
FBPPHM3007
FBPPHM3007
State Code
OAM81
OAM81
TGA Status
Replaced
Replaced
DTWD Status
Transition (Replaced)
Transition (Replaced)
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 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 occupational 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 column operation
- 2.2 Identify and report out of limit test results according to workplace procedures
- 2.3 Load product 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 the workplace procedures for shutting down the process
- 4.2 Safely shut down the process
- 4.3 Complete records according to workplace procedures
No information
No information
Replaces
| State Code | National Code | Title | Type |
|---|---|---|---|
| D4679 | FDFPH2004A | Operate a separation process using chromatography | Unit of competency |
Replaced By
| State Code | National Code | Title | Type |
|---|---|---|---|
| OCW24 | FBPPHM3019 | Operate a chromatography manufacturing process | Unit of competency |
| State Code | National Code | Title | Type |
|---|---|---|---|
| BEF7 | FBP30818 | Certificate III in Pharmaceutical Manufacturing | Qualification |