FBPPHM3004 — Clean and sanitise facilities and equipment

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What an assessment for FBPPHM3004 must cover

75 assessable components: 5 elements (31 performance criteria), 13 performance evidence and 26 knowledge evidence requirements, plus 5 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 Plan and prepare to clean pharmaceutical processing areas and equipment

1.1Obtain cleaning task requirements, including job specifications and workplace procedures for sampling and testing cleaning outcomes
1.2Identify surfaces and soil and dirt types and select appropriate cleaning techniques
1.3Select and prepare cleaning chemicals required for job
1.4Select and check cleaning equipment and consumables for serviceability and compliance with cleaning and sanitation requirements of GMP cleaning program
1.5Rectify or report faults before starting work
1.6Confirm services are available and ready for operation
1.7Source and fit personal protective equipment (PPE) according to procedures for health and safety in the workplace
1.8Obtain cleaning consumables to meet anticipated usage patterns
1.9Select and install signs and barricades according workplace procedures
1.10Set the plant for automated cleaning cycle or initiate a manual clean

2 Remove waste

2.1Collect and dispose of waste according to procedures and legislative requirements for the environment and health and safety in the workplace
2.2Clean and sanitise rubbish bins and insert new replacement bin liners according to workplace procedures

3 Clean and sanitise pharmaceutical processing surfaces

3.1Change status label of area and equipment and check status prior to cleaning
3.2Remove loose dirt and debris from pharmaceutical processing surfaces prior to applying cleaning treatment
3.3Follow cleaning steps according to workplace procedures
3.4Apply cleaning chemicals to pharmaceutical surfaces according to manufacturers’ specifications and workplace procedures
3.5Thoroughly rinse and dry surfaces according to workplace procedures
3.6Apply chemical disinfectants and sanitisers to surfaces according to workplace procedures
3.7Report practices inconsistent with GMP according to workplace procedures

4 Clean and sanitise pharmaceutical processing equipment

4.1Clean and sanitise processing equipment according to GMP requirements and workplace procedures
4.2Monitor the cleaning process and identify and report deviations from job specifications according to workplace procedures
4.3Inspect and confirm equipment cleanliness status against acceptance criteria and take appropriate action to rectify non-conformances
4.4Confirm relevant sampling or testing methods including sampling or testing points, types of samples and measurements requirements
4.5Take, collect, store and transport samples according to sampling plan, relevant methods and standards
4.6Return equipment to operating order
4.7Record and certify data and information about equipment cleaning and sanitising, including cleaning status, sampling and testing according to workplace procedures and GMP requirements

5 Return plant to operating condition

5.1Remove signs and barricades according to workplace procedures and work health and safety
5.2Clean, check and store cleaning equipment and PPE according to manufacturers’ specifications, environmental and workplace health and safety requirements
5.3Store and dispose of unused chemicals according to manufacturers’ specifications, and workplace health and safety requirements
5.4Order and replenish cleaning consumables
5.5Document tasks completed according to workplace procedures

Performance evidence

accessed cleaning schedules or other workplace information to identify cleaning requirements
interpreted workplace procedures applicable to cleaning operations, including pictorial and written signs/instructions
identified soil types present in the following work surfaces, and selected cleaning equipment and agents required to clean the surfaces: floors, walls, ceilings, benches, outer surfaces of equipment, door handles and door frames, light switches, vents, grills, pass-through cabinets
identified hazards and controlled risks, including contamination hazards encountered in pharmaceutical manufacturing environments
confirmed supply of necessary cleaning and sanitising equipment and services
replenished different types of consumables used in cleaning processes
selected and prepared cleaners and sanitisers according to workplace procedures
selected, fitted and used personal protective equipment (PPE) required for tasks
prepared equipment for cleaning according to manufacturers’ instructions, including: rendered equipment safe to clean; cleared product and waste materials; covered motors and instrumentation where steam or water hoses are used; dismantled and reassembled equipment parts for cleaning according to operation and maintenance manual
applied correct cleaning and sanitising procedures to equipment and surfaces
taken samples and conducted tests according to workplace procedures
inspected equipment to identify equipment condition and cleanliness
stored cleaners, sanitisers and related equipment according to workplace procedures

Knowledge evidence

responsibilities of cleaning staff and procedures for cleaning teams
common types of microbiological, physical and chemical contaminants in pharmaceutical processing facilities
Good Manufacturing Practice (GMP) requirements and role of cleaning and sanitising in preventing contamination of materials and products, and in the protection of personnel and external contractors
risks associated with cleaning and sanitising operations and cross contamination prevention
personal hygiene, clothing and footwear requirements, clothing storage and disposal for working in and moving between work areas
terminology relating to chemical cleaning and decontamination, including: cleaners, disinfectants, sanitisers, sterilants, fogging, fumigation
services used in a pharmaceutical manufacturing process, including: potable and purified water, steam, compressed and instrumentation air
types of cleaning equipment suitable for use in a pharmaceutical processing environment, including their use and storage
different cleaning methods: clean-in-place (CIP), clean-out-of place (COP), manual cleaning
purpose and basic principles of CIP, including the use and functions of caustic and acid solutions, and cleaning sequence and stages
advantages and disadvantage of automated and semi-automated CIP systems
types of cleaning equipment include: CIP spray balls, bottle brushes, disinfecting solutions, non-shedding wipes
hygienic vs unhygienic design features of facilities and equipment, including inserts and dead legs
the differences between: cleaning, disinfecting, sanitising, sterilising
properties and functions of different cleaning and sanitising agents for pharmaceutical industry
different levels of cleaning requirements depending on the reason for cleaning, and whether equipment is dedicated or shared
the influence of the time between manufacture and cleaning (dirty hold time), and the time between cleaning and use (clean hold time) on a cleaning process
acceptance criteria used to evaluate cleaning quality, including: how cleaning is measured, commonly used sampling and testing
considerations when choosing and using cleaning chemicals including: the correct selection of chemicals for the surface being cleaned; the chemical and physical properties of the soils or residues to be removed; the interactions between cleaning chemicals and the surfaces they may adhere to; the solubility of the soil/residue in the cleaning solution; the need to rotate sanitisers; the frequency of cleaning and sanitising; manual, semi-automated and fully automated cleaning methods; the variable factors that influence cleaning effectiveness and performance
critical parameters in a cleaning and sanitising process including: time, temperature, concentration
GMP requirements for the validation of cleaning processes
waste related to pharmaceutical manufacturing processes, including: cleaning material, product waste, hazardous waste, general processing and laboratory waste
waste collection, recycling and handling procedures relevant to own work responsibilities
procedures for responding to out-of-limits or unacceptable performance or outcomes
common practices inconsistent with GMP found in cleaning and sanitising operations, including: damage to plant or equipment, failure of cleaning regime, signs of pest infestation, missing or inaccurate records, failure to follow workplace procedures
purpose of keeping records and the recording requirements of GMP, including the legal significance of certifying and verifying GMP records

Foundation skills

Reading: Identify and follow signs, symbols, checklists, production schedules, cleaning schedules and other technical information relevant to cleaning and sanitising facilities and equipment Identify and follow workplace information, specifications and safety data sheets (SDS) Identify and interpret GMP information relevant to cleaning and sanitising facilities and equipment
Writing: Complete checklists, standard forms and reports relating to practices inconsistent with GMP
Oral communication: Use clear language to report contamination risks and practices inconsistent with GMP Participate in verbal exchanges to respond to questions and clarify information
Numeracy: Interpret measurements and numerical symbols in SDSs Record data and information using mathematical symbols and conventions
Navigate the world of work: Recognise and follow workplace requirements, including safety requirements and GMP, associated with own role and area of responsibility

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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Questions about assessing FBPPHM3004

What does an assessment tool for FBPPHM3004 need to cover?

To satisfy the Principles of Assessment and Rules of Evidence, an assessment for FBPPHM3004 needs to address all 75 unit components: 5 elements with 31 performance criteria, 13 performance evidence requirements, 26 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 FBPPHM3004?

Auditori pulls the current release of FBPPHM3004 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 FBPPHM3004 — with no card and no subscription required. After that it's pay-as-you-go per unit.

Can I check my existing FBPPHM3004 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 FBPPHM3004, showing exactly what's covered and what's missing. Mapping costs a quarter of a credit.

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