Application
This unit of competency describes the skills and knowledge required to set up, operate, adjust and shut down an encapsulation process in a pharmaceutical manufacturing facility.
The unit applies to individuals who apply Good Manufacturing Practice (GMP) and operating principles to the encapsulation 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 encapsulation process for operation | 1.1 Confirm materials and equipment are available to meet production requirements 1.2 Confirm cleaning and maintenance requirements and status 1.3 Select and fit personal protective equipment and contamination prevention clothing according to workplace procedures 1.4 Fit and adjust machine components and related attachments according to production requirements and equipment operation and maintenance manual 1.5 Enter processing and operating parameters according to safety and production requirements 1.6 Check and adjust equipment performance, according to equipment operating procedures 1.7 Conduct pre-start checks according to workplace procedures |
2. Operate and monitor encapsulation process | 2.1 Start up and monitor encapsulation process to confirm specifications are within required limits 2.2 Identify and report out of limit capsule 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 Contain, remove and report spillages according to workplace procedures 2.6 Complete documentation according to workplace procedures |
3. Shut down encapsulation process | 3.1 Confirm the workplace procedures for shutting down the process 3.2 Complete end-of-batch procedures according to batch instructions and workplace procedures 3.3 Safely shut down the process 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 the encapsulation process |
Writing | Complete workplace documentation using appropriate language and in required format |
Numeracy | Interpret specifications for flow rates and product quantity |
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 must include: | carrying out required area or line clearances inspecting equipment condition to identify signs of wear confirming all safety equipment are in place and operational confirming that equipment is clean or sanitised confirming that equipment is correctly configured for processing requirements. |
Sectors
Pharmaceutical (PHM)