FBPPHM3018 — Operate a sterilisation process using an autoclave
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What an assessment for FBPPHM3018 must cover
81 assessable components: 3 elements (14 performance criteria), 19 performance evidence and 45 knowledge evidence requirements, plus 3 foundation skills. An audit-defensible tool maps every question and task back to these — that mapping is the coverage matrix Auditori generates alongside the assessment.
Elements & performance criteria
1 Prepare and initiate operation of equipment
- 1.1Check autoclave is operational and sterilisation load is available
- 1.2Prepare items for sterilisation load by stacking, wrapping, taping or sealing according to Standard Operating Procedures (SOP)
- 1.3Mark bags as required according to SOP
- 1.4Load autoclave and position temperature load probe according to load pattern requirements detailed in the SOP
- 1.5Run pre-start leak test cycle and select the correct sterilisation cycle according to SOP
- 1.6Initiate the autoclave cycle
2 Review autoclave printout at end of cycle
- 2.1Review autoclave cycle printout or electronic report and confirm correct cycle was run with no faults or alarms detected
- 2.2Complete documentation according to SOP
3 Remove items and follow shut down procedures
- 3.1Commence shutdown of autoclave by confirming autoclave cycle is complete and autoclave is safe to open according to SOP
- 3.2Remove items safely from autoclave and check contents
- 3.3Check data logging or relevant indicators have been activated according to SOP
- 3.4Confirm items are dry and sterilised
- 3.5Clean autoclave according to SOP
- 3.6Complete records according to SOP
Performance evidence
- accessed Standard Operating Procedure (SOP) information to confirm sterilisation requirements
- confirmed supply of product or materials for the sterilisation process
- prepared items by stacking autoclave dolly with product for terminal sterilisation or wrapping, taping, or sealing in an autoclave bag product for aseptic processing
- marked bags with temperature-sensitive tape or chemical indicators
- positioned any moveable load probe and loaded items in correct orientation according to SOP and validated load pattern requirements
- conducted pre-start checks required for safe operation of the autoclave, including:
- carried out required area or line clearances
- inspected equipment condition to identify signs of wear
- confirmed all safety equipment in place and operational
- confirmed sterilising equipment clean or sanitised
- confirmed all pre-start cycles have been run, including a leak test
- confirmed sterilising equipment correctly set up for processing requirements
- selected correct sterilisation cycle as per the SOP
- reviewed cycle print out to confirm the cycle was completed satisfactorily with no alarms or faults
- taken corrective action in response to a non-conformance
- opened autoclave and removed items from autoclave according to workplace procedures
- safely shut down the process according to workplace procedures
- cleaned and maintained work area to meet workplace cleaning standards and environmental requirements
- completed records according to SOP
Knowledge evidence
- requirements for autoclaving for microbial reduction/sterility
- stages of the sterilisation process, including:
- relationship between time, temperature and pressure as they affect kill rate
- variables that impact effectiveness of sterilisation
- nature of items to be sterilised using an autoclave, different cycle types used and related handling and preparation requirements, including:
- porous loads
- non-porous loads
- position of probes
- nature of wrapping materials suitable for use, including:
- methods used to wrap or bag items
- methods used to monitor whether time and temperature parameters are met, including heat-sensitive tape or markers
- significance of validated loading patterns in achieving effective sterilisation
- basic operating principles of equipment, requirements and parameters of autoclave, including:
- main equipment components including filters, vacuum pumps, condensers and the autoclave chamber
- utilities requirements for a GMP autoclave including compressed air, electricity, processed water steam supply and cooling water
- time and temperature parameters required to achieve sterilisation and corrective actions required where operation falls outside specified parameters
- typical equipment faults and related causes, including signs and symptoms of faulty equipment and early warning signs of potential problems
- status and purpose of guards
- equipment operating capacities and applications
- purpose and location of sensors and related feedback instrumentation
- corrective actions required where operation is outside of specified parameters
- calibration schedule and procedures to confirm that instruments are within calibration
- health and safety hazards related to autoclave operation and associated control measures, including working with superheated steam and hot surfaces, manual handling and steam leaks
- pre-start check requirements, including:
- carrying out required area or line clearances
- inspecting equipment condition to identify signs of wear
- confirming all safety equipment in place and operational
- confirming equipment is clean or sanitised
- confirming equipment is correctly configured for processing requirements
- evaluation and in-process monitoring of sterilisation process indicators, including:
- biological
- chemical
- physical
- methods used to monitor the sterilisation process, including:
- inspecting
- measuring
- testing
- requirements of different shutdowns, including:
- emergency and routine shutdowns
- procedures to follow in the event of a power outage
- isolation, lock out and tag out procedures and responsibilities
- operating principles of process control
- Good Manufacturing Practice (GMP) requirements associated with a sterilisation process and related control measures
- environmental issues and controls relevant to the sterilisation process including waste collection and handling procedures
- requirements for completion of workplace documentation
Foundation skills
- Reading: Identify relevant information from workplace documentation and interpret requirements for the sterilisation process
- Writing: Complete workplace documentation using appropriate language and in required format
- Numeracy: Confirm number of items according to loading pattern Interpret time and temperature specifications for cycle parameters Confirm post cycle results meet sterilisation requirements
Unit content sourced from training.gov.au — © Commonwealth of Australia, licensed under CC BY 4.0. Auditori is not affiliated with the Department of Employment and Workplace Relations.
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Real, unedited Auditori output (RIIHAN201E shown), branded for a sample RTO:
Questions about assessing FBPPHM3018
What does an assessment tool for FBPPHM3018 need to cover?
To satisfy the Principles of Assessment and Rules of Evidence, an assessment for FBPPHM3018 needs to address all 81 unit components: 3 elements with 14 performance criteria, 19 performance evidence requirements, 45 knowledge evidence requirements, and the foundation skills. A coverage matrix mapping each question and task to these components is what an auditor looks for.
How does Auditori generate an assessment tool for FBPPHM3018?
Auditori pulls the current release of FBPPHM3018 from training.gov.au and generates a complete package: candidate assessment, assessor guide with model answers and observation criteria, and a coverage matrix mapping every component. A suitably qualified person then reviews and approves the draft in a built-in workflow — consistent with ASQA's guidance on AI use in VET — before export as branded PDF and editable Word.
Is the first assessment tool really free?
Yes. Every new account includes one free credit — enough to generate the complete assessment tool for FBPPHM3018 — with no card and no subscription required. After that it's pay-as-you-go per unit.
Can I check my existing FBPPHM3018 assessment instead of generating a new one?
Yes — upload your existing assessment or learner guide and Auditori maps it against every element, performance criterion, PE and KE of FBPPHM3018, showing exactly what's covered and what's missing. Mapping costs a quarter of a credit.
Related units
- FBPPHM2001 — Follow work procedures to maintain Good Manufacturing Practice requirements
- FBPPHM3003 — Work in a controlled environment
- FBPPHM3004 — Clean and sanitise facilities and equipment
- FBPPHM3005 — Operate a concentration process
- FBPPHM3006 — Operate an extraction process
- FBPPHM3008 — Operate an aseptic fill and seal process
- FBPPHM3009 — Operate an aseptic form, fill and seal process
- FBPPHM3010 — Operate a compressing process
- FBPPHM3011 — Dispense pharmaceutical raw materials
- FBPPHM3012 — Operate an encapsulation process
- FBPPHM3013 — Operate a granulation process
- FBPPHM3014 — Operate a liquid manufacturing process
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