Elements and Performance Criteria
- Set up filling and sealing process
- Identify production requirements from workplace documentation
- Confirm materials, packaging components and consumables are available to meet batch and production requirements
- Confirm required facilities and equipment are available
- Source and fit cleanroom garments and personal protective equipment according to workplace gowning standard operating procedures (SOP)
- Maintain sterile quality of the gown according to workplace gowning SOP
- Fit and adjust machine components and attachments according to production requirements and equipment operation and maintenance manual
- Enter processing and operating parameters according to safety and production requirements
- Check and adjust equipment performance according to equipment operating procedures
- Conduct pre-start checks according to workplace procedures
- Operate and monitor a filling and sealing process
- Start up and monitor aseptic fill and seal process to confirm products are within required limits
- Monitor packaging quality and seal integrity to confirm that specifications are met
- Identify and report out of limit products or processes according to workplace procedures
- Maintain work area according to workplace cleaning standards
- Maintain consistent aseptic techniques
- Conduct process and sampling according to safety requirements and environmental monitoring procedures
- Contain, remove and report spillages according to procedures
- Complete documentation according to workplace requirements
- Shut down filling and sealing process
- Confirm the workplace procedures for shutting down the process
- Complete end-of-batch procedures according to batch instructions
- Safely shut down the process
- Clean sealing equipment according to workplace procedures
- De-gown according to workplace gowning SOP
- Complete records according to workplace procedures