HLTPHA016 — Conduct small-scale compounding and labelling of aseptic pharmaceutical products

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What an assessment for HLTPHA016 must cover

146 assessable components: 9 elements (53 performance criteria), 8 performance evidence and 85 knowledge evidence requirements. 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 Source information on formula.

1.1Select appropriate formula and master work sheet for the product, based on correct interpretation of the prescription or medication order.
1.2Confirm suitability of chosen master work sheet and availability of resources.
1.3Obtain approval from an authorised person to proceed.

2 Prepare for production process.

2.1Confirm availability of appropriate cleanroom and containment device required to compound the item.
2.2Comply with personal protection equipment (PPE), safety and personal hygiene procedures prior to entering the work area.
2.3Clean work area and equipment correctly according to organisational standards.
2.4Maintain inventory levels of materials and disposable equipment.
2.5Prepare a work sheet referenced from a master work sheet.
2.6Assign product batch number according to organisational numbering system.
2.7Verify that the work sheets are clearly written in logical order with clear directions and contain all the required information.
2.8Generate the product labels referenced from the master label detailed on the master work sheet.
2.9Check and note the number of labels generated.
2.10Submit work sheet and labels to an authorised person for approval.
2.11Check and set up compounding requirements and disposable equipment.

3 Obtain equipment and supplies.

3.1Assemble materials used in aseptic compounding as listed in the work sheet, according to stock levels and stock requisitioning procedures.
3.2Check materials to ensure they have been released from quarantine for use by authorised persons.
3.3Verify materials against compounding work sheet and record material batch numbers and expiry dates.
3.4Select appropriate types, size and features of containers and packaging listed in the work sheet.
3.5Weigh or measure materials in designated area.
3.6Obtain required authorisation or checks at designated points according to the work sheet.

4 Prepare for sterile compounding.

4.1Transfer raw materials, disposable equipment, required containers or packaging and covered work sheet to pre-production area.
4.2Follow hand washing, gowning and gloving procedures.
4.3Disinfect and transfer materials, disposable equipment and work sheet to sterile production area.

5 Prepare for cytotoxic production.

5.1Check that cytotoxic spill cleaning kits are available in all production areas.
5.2Select and use appropriate sterile personal protective equipment for safe handling and preparation of cytotoxic drugs as required.
5.3Follow specific procedures to minimise risk of exposure to cytotoxic drugs.

6 Compound products using aseptic techniques.

6.1Allocate approved bulk materials, intermediary products and containers to appropriate equipment.
6.2Incorporate materials according to work sheet using appropriate manipulation technique.
6.3Compound product according to method on compounding work sheet.
6.4Prepare cytotoxic products using procedures for safe handling of cytotoxic drugs.
6.5Operate specialist equipment and use specialist supplies in sterile production preparation.
6.6Perform verification procedures and inspect finished product for deviations and report to an authorised person.
6.7Pack compounded product into appropriate container as specified on the work sheet and following approval from an authorised person.
6.8Label containers according to labelling specifications on the work sheet.
6.9Obtain required authorisation or checks at designated points according to organisational procedures.

7 Complete production process.

7.1Reconcile the number of labels printed with number used and report discrepancies to an authorised person.
7.2Place product in quarantine area under appropriate storage conditions.
7.3Clean equipment and compounding area and dispose of disposable equipment safely and according to organisational requirements.
7.4Follow procedures for cleaning cytotoxic spills, and exposure to cytotoxic drugs.
7.5Complete required documentation and forward to an authorised person.
7.6Obtain final approval and report any discrepancies to an authorised person before releasing compounded medication to storage areas.
7.7Discard waste materials appropriately according to workplace health and safety (WHS) and environmental standards.

8 Participate in quality control.

8.1Pack and label a retention sample or quality control sample if specified on the work sheet.
8.2Submit product sample and relevant documentation to quality control.
8.3Conduct sessional, weekly and monthly cleaning of containment devices and cleanroom as per cleanroom standards.
8.4Perform environmental monitoring and report abnormal readings to an authorised person.
8.5Record and file product quality control assay results and compounding area environmental monitoring results.

9 Store and transport released products.

9.1Store products according to the work sheet.
9.2Obtain released products from quarantine store.
9.3Pack released products into delivery containers which will maintain the required ambient conditions for the products.
9.4Deliver products to destination ensuring safe transport of cytotoxic products.
9.5Advise receipting area personnel of storage requirements.
9.6Complete and file records or work sheets according to organisational requirements.

Performance evidence

follow established procedures and industry codes to produce 10 aseptic products accurately and safely working within the requirements of sterile areas, air locks and containment devices and in the course of the above:
perform regular quality control activities pertaining to the cleanroom including on at least one occasion:
weekly and monthly cleaning
environmental monitoring
validate at least one Aseptic Technique including training and validation record and aseptic technique assessment
complete finger dab or glove prints on at least one occasion
identify issues outside scope of own practice and refer to an authorised person
perform the activities outlined in the performance criteria of this unit during a period of at least 240 hours of work related to hospital or health services pharmacy support in a clinical workplace environment. These 240 hours may be applied collectively across all units of competency that include the requirement for workplace hours for the purposes of assessment.

Knowledge evidence

National, State or Territory legal and ethical requirements for pharmacy work, and how these are applied in organisations, including:
codes of conduct
duty of care and implications of negligence
privacy, confidentiality and disclosure
records management
rights and responsibilities of workers, employers and patients
specific legislation:
medication and their use
the practice of pharmacy
different schedules of medication and pharmaceutical products
work role boundaries including responsibilities and limitations in compounding products
work health and safety
key information in standard pharmaceutical references and their use in compounding, including:
Australian Pharmaceutical Formulary Handbook (APF)
Monthly Index of Medical Specialities (MIMS) or AusDI Advanced
Australian Medicines Handbook (AMH)
Micromedex
rationale and key features of:
The Society of Hospital Pharmacists (SHPA) Standards of Practice for Compounding and Aseptic Preparation in Pharmacy
Pharmaceutical Inspection Convention/Pharmaceutical Inspection Co-operation Scheme (PIC/S) Guide to good practices for the preparation of medicinal products in healthcare establishments (PE010-3)
USP-NF 797 Pharmaceutical Compounding - Sterile Preparations guidelines as required by the Pharmacy Board of Australia
product identification and handling, including those for:
formulary medication and non-formulary medication
products with the required integrity as well as those whose integrity has been compromised
routine of handling products and products requiring special handling
nature and use of different dosage forms, including:
oral
parenteral products
topical
infection control requirements for small scale compounding of aseptic pharmaceutical products, including:
aseptic technique
correct disposal of sharps and residues
regular cleaning and disinfection processes plus sterilisation of pharmaceuticals
personal hygiene and clothing standards
sources and types of contamination and required responses including microbial and environmental monitoring
processes relating to aseptic, including:
calculations for all sterile admixtures
chemical and physical properties of materials in relation to formulation and compounding
principles and procedures of formulae calculations, weights and measures
principles of aseptic technique, including cytotoxic compounding
processes for dilution, suspension, incorporation and reconstitution
use of terminal filtration
risk considerations and procedures for pharmaceutical compounding:
product security
handling and storage of hazardous materials
quarantine periods
management of cytotoxic spills
specific hazards related to cytotoxic manufacture
transport of cytotoxic medications
requirements for formulated compounding documentation, including:
different documentation types, their scope and purpose
worksheet processes
information quality control requirements including clarity, logic and completeness
specific labelling requirements for compounded products, including:
adherence to legislative requirements
name, form and strength of product
ancillary labels as part of label details
hazard warnings
spacing for entry of batch numbers and expiry dates
packaging methods, container materials and principles for selection
storage and transport requirements and rationale for different types of product including:
hazardous materials
special storage considerations:
humidity
isolation
light
temperature
ventilation
Operation and function of a clean room or isolator room:
differences between aseptic and hazardous including Cytotoxic or Biological cleanrooms
airflows and pressures
environmental grades of each cleanroom
cleanroom behaviour
quality control processes involved in maintenance of cleanroom
knowledge to successfully operate the containment devices within a cleanroom or isolator room:
understand the differences between:
laminar flow cabinets
biological safety cabinets
cytotoxic drug safety cabinets
Isolators including Type 1 and Type 2
cabinet airflows
action to be taken in event of alarm or malfunction
features and use of pharmacy systems used for aseptic compounding
circumstances that require compounding of the product within a containment device
environmental and WHS standards for waste disposal.

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 HLTPHA016

What does an assessment tool for HLTPHA016 need to cover?

To satisfy the Principles of Assessment and Rules of Evidence, an assessment for HLTPHA016 needs to address all 146 unit components: 9 elements with 53 performance criteria, 8 performance evidence requirements, 85 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 HLTPHA016?

Auditori pulls the current release of HLTPHA016 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 HLTPHA016 — with no card and no subscription required. After that it's pay-as-you-go per unit.

Can I check my existing HLTPHA016 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 HLTPHA016, showing exactly what's covered and what's missing. Mapping costs a quarter of a credit.

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