Application
This unit of competency describes the skills and knowledge required to set up, operate, monitor, adjust and shut down a concentration process in a pharmaceutical manufacturing facility.
The unit applies to individuals who apply Good Manufacturing Practice (GMP) and operating principles to the concentration 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.
Elements and Performance Criteria
Elements | Performance Criteria |
Elements describe the essential outcomes. | Performance criteria describe the performance needed to demonstrate achievement of the element. |
1. Prepare the concentration equipment and process for operation | 1.1 Identify production requirements from workplace documentation 1.2 Confirm materials and services 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 Carry out line clearance procedures according to production requirements and equipment operation and maintenance manual 1.6 Follow procedures to eliminate or control the risk of cross-contamination 1.7 Conduct pre-start checks and start up concentration process according to workplace procedures |
2. Operate and monitor the concentration process | 2.1 Monitor concentration process to confirm that specifications are within required limits 2.2 Identify and report out of limit products 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 requirements |
3. Shut down the concentration process | 3.1 Confirm the workplace procedures for shutting down the process 3.2 Safely shut down the process 3.3 Report maintenance requirements according to workplace procedures 3.4 Complete records according to workplace procedures |
Foundation Skills
This section describes those language, literacy, numeracy and employment skills that are essential for performance in this unit of competency but are not explicit in the performance criteria.
Skill | Description |
Reading | Identify relevant information from workplace documentation and interpret requirements for a concentration process |
Writing | Complete workplace documentation using appropriate language and in required format |
Numeracy | Interpret measurement information to set, monitor and adjust process parameters |
Navigate the world of work | Identify workplace procedures relevant to own role |
Interact with others | Report operational and safety information to relevant personnel using required communication method |
Get the work done | Plan, organise and implement tasks required to achieve production outcomes Use problem-solving skills to analyse product and process faults and decide on appropriate action |
Range Statement
This section specifies different work environments and conditions that may affect performance. Essential operating conditions that may be present (depending on the work situation, needs of the candidate, accessibility of the item, and local industry and regional contexts) are included.
Pre-start checks | carrying out required area or line clearances inspecting equipment condition to identify signs of wear confirming all safety equipment is in place and operational confirming that equipment is clean or sanitised confirming that equipment is correctly configured for processing requirements. |
Sectors
Pharmaceutical (PHM)