Unit of competency Outline

Date retreived
22/07/2026 11:34 PM AWST

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Operate an aseptic fill and seal process

Operate an aseptic fill and seal process

Unit of competency
National Code
FBPPHM3008
State Code
OAO10
TGA Status
Current
DTWD Status
Approved
Current Release Number
2.00
Current Release Date
21/01/2021
View on TGA
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
55
Description
This unit of competency describes the skills and knowledge required to set up, operate, monitor, adjust and shut down an aseptic fill and seal process within a graded cleanroom environment in a pharmaceutical manufacturing facility.The unit applies to individuals who apply Good Manufacturing Practice (GMP) requirements and operation principles to the aseptic fill and seal process. Individuals work under broad direction and take responsibility for their own work.No licensing, legislative or certification requirements apply to this unit at the time of publication.
Notes
Elements and Performance Criteria
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 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
No information
No information
Replaces
State Code National Code Title Type
D4680 FDFPH2005A Operate an aseptic fill and seal process Unit of competency