Elements

Performance Criteria

Elements describe the essential outcomes.

Performance criteria describe the performance needed to demonstrate achievement of the element.

1. Set up filling and sealing process

1.1 Identify production requirements from workplace documentation

1.2 Confirm materials, packaging components and consumables are available to meet batch and production requirements

1.3 Confirm required facilities and equipment are available

1.4 Source and fit cleanroom garments and personal protective equipment according to workplace gowning standard operating procedures (SOP)

1.5 Maintain sterile quality of the gown according to workplace gowning SOP

1.6 Fit and adjust machine components and attachments according to production requirements and equipment operation and maintenance manual

1.7 Enter processing and operating parameters according to safety and production requirements

1.8 Check and adjust equipment performance according to equipment operating procedures

1.9 Conduct pre-start checks according to workplace procedures

2. Operate and monitor a filling and sealing process

2.1 Start up and monitor aseptic fill and seal process to confirm products are within required limits

2.2 Monitor packaging quality and seal integrity to confirm that specifications are met

2.3 Identify and report out of limit products or processes according to workplace procedures

2.4 Maintain work area according to workplace cleaning standards

2.5 Maintain consistent aseptic techniques

2.6 Conduct process and sampling according to safety requirements and environmental monitoring procedures

2.7 Contain, remove and report spillages according to procedures

2.8 Complete documentation according to workplace requirements

3. Shut down filling and sealing process

3.1 Confirm the workplace procedures for shutting down the process

3.2 Complete end-of-batch procedures according to batch instructions

3.3 Safely shut down the process

3.4 Clean sealing equipment according to workplace procedures

3.5 De-gown according to workplace gowning SOP

3.6 Complete records according to workplace procedures

Skill

Description

Reading

Identify relevant information from workplace documentation, standard operating procedures and batch instructions and interpret requirements for the aseptic fill and seal process

Writing

Complete workplace documentation using appropriate language and in required format

Numeracy

Confirm process specifications for flow rates, temperature, fill levels, weights and volumes

Navigate the world of work

Identify workplace requirements, including safety requirements and GMP requirements, associated with own role

Interact with others

Report operational and safety information to relevant personnel using required communication method

Get the work done

Use problem-solving skills to analyse product and process faults and decide on appropriate action

Cleanroom garments and personal protective equipment must include:

coverall

disposable and/or reusable:

surgical or elastic gloves

face masks

hair nets and hoods

beard/moustache covers

goggles or glasses

overshoes or cleanroom boots and/or shoe covers.

Pre-start checks must include:

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.