Unit of Competency Mapping – Information for Teachers/Assessors – Information for Learners
HLTPH415B Mapping and Delivery Guide Conduct small-scale compounding of aseptic pharmaceutical products
Version 1.0 Issue Date: May 2024
Qualification
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Unit of Competency
HLTPH415B - Conduct small-scale compounding of aseptic pharmaceutical products
Description
This unit of competency describes the skills and knowledge required to manufacture and compound sterile pharmaceutical products from fixed formulae. This includes cytotoxic and total parental nutrition (TPN) products
Employability Skills
This unit contains Employability Skills
Learning Outcomes and Application
All tasks are conducted according to NCCTG Guidelines for the Preparation of Pharmaceuticals in Australian Hospitals and standard operating procedures (SOPs)It should be noted that assessment for this unit of competency does not replace initial and ongoing validation processes required in the workplace to undertake aseptic and cytotoxic productionWork performed requires a range of well developed skills where discretion and judgement is requiredIndividuals will take responsibility for their own outputs and limited responsibility for the outputs of others
Duration and Setting
X weeks, nominally xx hours, delivered in a classroom/online/blended learning setting.
Prerequisites/co-requisites
Not Applicable
Competency Field
Development and validation strategy and guide for assessors and learners
Student Learning Resources
Handouts Activities
Slides PPT
Assessment 1
Assessment 2
Assessment 3
Assessment 4
Elements of Competency
Performance Criteria
Element: Prepare tor production process
Identify the circumstances that require compounding of the product within a laminar flow hood/clean room or cytotoxic drug safety cabinet/cytotoxic suite or room or isolator
Confirm relevant legal, quality and hospital policy factors in sterile production
Follow correct dress code, safety and personal hygiene procedures and Personal Protective Equipment (PPE)
Maintain preparation areas at NCCTG requirements and Australian Standards for area classification
Clean work area and equipment correctly
Maintain inventory levels of materials and disposable equipment
Obtain and clarify the confirmed and formulated manufacturing order from pharmacist
Prepare production work sheet from formulated manufacturing order/master batch sheet
Interpret manufacture work sheet and assign appropriate product batch number
Check and set up compounding machinery or disposable equipment and any specialist equipment and clothing required for the compounding of sterile pharmaceutical products (e.g. cytotoxic spill cleaning kits)
Prepare labels and check number of labels generated
Element: Prepare for cytotoxic production
Apply an understanding of cytotoxic drugs and their basic pharmacology to the preparation of products
Apply an understanding of SHPA Standards for preparation of cytotoxic drugs and relevant State legislation
Make cytotoxic spill cleaning kits available in all production areas
Use specialist equipment and clothing for the safe handling and preparation of cytotoxic drugs
Identify exposure hazards and mitigation requirements related to cytotoxic drugs
Element: Obtain equipment, consumables, containers required for manufacturing process
Acquire all materials used in aseptic production according to stock levels and stock requisitioning procedures
Check materials to ensure they have been released from quarantine for use by authorised persons
Verify materials against manufacturing work sheet and record material batch numbers
Weigh and measure materials in designated weighing area
Allocate raw materials to appropriate manufacturing machinery, where applicable
Select appropriate types, size and features of containers and packaging in sterile manufacturing
Obtain appropriate authorisation/checks at designated points
Element: Prepare for sterile manufacturing
Transfer raw materials, disposable equipment, required containers or packaging and covered work sheet to pre-production area
Follow hand washing, gowning and appropriate gloving procedures
Disinfect and transfer materials, disposable equipment and work sheet to sterile production area
Element: Manufacture/compound products using aseptic techniques
Comply with NCCTG Guidelines for the Preparation of Pharmaceuticals in Hospitals and Australian Standards for operator safety when cleaning, setting up work station and transference of materials
Allocate approved bulk materials, intermediary products and containers to appropriate machinery / equipment where required
Incorporate materials according to batch documentation
Compound product according to method on manufacturing work sheet (e.g. aseptically transfer materials from one vessel to another) and in compliance with standard operating procedures for any measuring device or machinery use
Prepare cytotoxic products using procedures for handling cytotoxic drugs.
Work within the requirements of sterile areas, air locks, laminar flow hoods and cytotoxic drug safety cabinet / isolator
Operate specialist equipment and use specialist supplies in sterile production preparation
Obtain required authorisation/checks at designated points
Monitor product and adjust any necessary pharmaceutical/compounding to ensure product complies with work sheet specifications
Perform checking procedure and inspect finished product for deviations
Pack product using appropriate packaging devices/machinery as specified on the work sheet, and following approval from an authorised person
Label containers/units according to labelling specifications on the work sheet
Pack and label a retention sample and/or quality control sample if specified on the work sheet
Element: Complete production process
Place product in quarantine area under appropriate storage conditions, where specified
Clean machinery and manufacturing area
Identify procedures for cleaning cytotoxic spills and the course of action taken after accidental contact with cytotoxic drugs and their safe disposal
Complete machinery and equipment records and/or logs
Reconcile the number of labels printed with the number used and discard excess. Note discrepancies in labels and documentation
Complete documentation and forward to appropriate person
Report discrepancies to an authorised person
Obtain final clearance from an authorised person
Element: Participate in quality control
Perform environmental monitoring according to organisation requirements and report abnormal readings to an authorised person
Submit product sample and relevant documentation to quality control, where specified
Record and file product quality control assay results and manufacturing area environmental monitoring results
Element: Transport and store release product
Store products according to manufacturing documentation
Obtain released product(s) from quarantine store
Pack released product(s) into appropriate delivery containers
Deliver product to store/dispensary by appropriate means, ensuring safe transport of cytotoxic products
Advise receipting area personnel of any special storage requirements
Complete and file records and/or work sheets
Evidence Required
List the assessment methods to be used and the context and resources required for assessment. Copy and paste the relevant sections from the evidence guide below and then re-write these in plain English.
The evidence guide provides advice on assessment and must be read in conjunction with the Performance Criteria, Required Skills and Knowledge, the Range Statement and the Assessment Guidelines for this Training Package.
Critical aspects for assessment and evidence required to demonstrate this competency unit:
The individual being assessed must provide evidence of specified essential knowledge as well as skills
Observation of workplace performance is essential for assessment of this unit
Consistency of performance should be demonstrated over the required range of situations relevant to the workplace
Where, for reasons of safety, space, or access to equipment and resources, assessment takes place away from the workplace, the assessment environment should represent workplace conditions as closely as possible
Context of and specific resources for assessment:
Assessment should replicate workplace conditions as far as possible. It may be necessary to undertake the assessment in another workplace or hospital that has the required facilities
Simulations may be used to represent workplace conditions as closely as possible Acceptable simulation requires:
Scope to determine that work is conducted within legislative and regulatory requirements
Scope to determine that work is conducted within OHS and infection control requirements
Resources essential for assessment include:
Access to relevant workplace or appropriately simulated environment where assessment can take place
Relevant legislation, regulations and guidelines
Weighing and measuring equipment
Relevant manufacturing and packing machinery
Instructions on the use of equipment
Aseptic/cytotoxic facilities
Note that assessment for this competency unit does not replace initial and ongoing formal validation processes required in the workplace to undertake aseptic or cytotoxic production (This usually requires the preparation and microbiological sampling of a number of prepared products for initial validation and at regular future intervals, as part of ongoing validation)
Method of assessment may include:
Observation in the work place (if possible)
Written assignments/projects, eg for fundamentals of microbiology and principles of cleaning and disinfection
Interviewing and questioning
Formal appraisal systems
Supporting statement of supervisor(s)
Formal validation processes required in the workplace to undertake aseptic or cytotoxic production are outside the assessment for this competency unit.
Access and equity considerations:
All workers in the health industry should be aware of access and equity issues in relation to their own area of work
All workers should develop their ability to work in a culturally diverse environment
In recognition of particular health issues facing Aboriginal and Torres Strait Islander communities, workers should be aware of cultural, historical and current issues impacting on health of Aboriginal and Torres Strait Islander people
Assessors and trainers must take into account relevant access and equity issues, in particular relating to factors impacting on health of Aboriginal and/or Torres Strait Islander clients and communities
Submission Requirements
List each assessment task's title, type (eg project, observation/demonstration, essay, assignment, checklist) and due date here
Assessment task 1: [title] Due date:
(add new lines for each of the assessment tasks)
Assessment Tasks
Copy and paste from the following data to produce each assessment task. Write these in plain English and spell out how, when and where the task is to be carried out, under what conditions, and what resources are needed. Include guidelines about how well the candidate has to perform a task for it to be judged satisfactory.
This describes the essential skills and knowledge and their level required for this unit.
Essential knowledge:
Basic hygiene and the importance of maintaining a clean working environment and equipment
Calculations and content rationale for all sterile admixtures
Chemical and physical properties of materials in relation to formulation and compounding
Circumstances requiring sterile medication
Correct disposal of sharps, drug residues, cytotoxics etc.
Cytotoxic use and therapeutic effect
Different types of filters/compatibility of filters with pharmaceutical products.
Hazards related to cytotoxic manufacture
Identification of the circumstances that require compounding of the product within a laminar flow hood / clean room or cytotoxic drug safety cabinet / cytotoxic suite or room or isolator.
Identification and handling of products, including
formulary drugs and non-formulary drugs eg clinical trial drugs and special access scheme drugs
products with the required integrity as well as those whose integrity has been compromised eg damaged, contaminated or deteriorated stock
routine handling of products and products requiring special handling, eg cytotoxics and its spill management, refrigerated and frozen items, light sensitive materials and flammables
Infection control policies, guidelines and symbols and their relevance to working in a hospital pharmacy
Knowledge of and the rationale for applicable legislation, organisation policy and in-house standard operating procedures (SOPs), relating to the small scale manufacture of aseptic pharmaceutical products, including cytotoxic products
Maintenance principles and procedures of clean work environments
Management of cytotoxic spills
Nature and use of different dosage forms
OHS policies, guidelines and symbols and their relevance to working in a hospital pharmacy
Packaging methods, container materials and principles for selection
Personal hygiene and clothing standards for manufacture
Pharmacy computer systems
Preparation of worksheets
Principles and procedures of formulae calculations, weights and measures
Principles and procedures of maintaining security of pharmaceutical products
continued ...
Essential knowledge (contd):
Principles of aseptic technique and cytotoxic manufacturing aseptic technique
Principles of handling and storage of hazardous materials
Principles of record keeping
Processes for dilution, suspension, incorporation and reconstitution
Purpose of batch numbering and expiry date on medicines
Purpose of information to be shown on medicine packs, eg product name, batch numbering and expiry date Basic principles of manufacturing processes
Sources and types of contamination - microbial, cross-chemical, physical, environmental and corrective strategies
Specific labelling requirements for aseptically prepared products
Sterilisation of pharmaceuticals, use of terminal filtration
Storage requirements and rationale for different types of product
Transport of cytotoxic medications
Use of dosage forms relating to parenteral products ie intrathecal, epidural injections
Essential skills:
It is critical that the candidate demonstrate the ability to:
Complete and file documentation
Compound raw materials correctly and safely to achieve a quality product
Perform aseptic cleaning and waste management
Perform correct aseptic techniques, including general aseptic techniques and cytotoxic aseptic technique
Perform quality assurance monitoring
Prepare, process and manufacture quality pharmaceutical products for fixed formulae
Produce a product free from microbial or cross contamination
Refer issues identified outside scope of practice to an authorised person
Transport and store product according to NCCTG Guidelines for the Preparation of Pharmaceuticals in Hospitals
Use personal protective equipment appropriately
Work in a safe manner
Work in accordance with relevant organisation policy, legislative requirements, industrial awards and agreements and in-house operating procedures (SOPs)
In addition, the candidate must be able to effectively do the task outlined in elements and performance criteria of this unit, manage the task and manage contingencies in the context of the identified work role
This includes the ability to:
Assemble, maintain, clean and use all equipment used in manufacturing process in a correct and safe manner and ensure a clean work environments
Calculate drug requirements for manufacturing
Perform aseptic techniques and aseptic transfers
Perform cytotoxic aseptic technique
Select and maintain appropriate equipment for manufacturing task
Take into account opportunities to address waste minimisation, environmental responsibility and sustainable practice issues
Use available resources and prioritise workload
Use literacy, numeracy and oral communication skills required to fulfil the position in a safe manner as specified by the health care facility
Use problem solving skills
The Range Statement relates to the unit of competency as a whole. It allows for different work environments and situations that may affect performance. Add any essential operating conditions that may be present with training and assessment depending on the work situation, needs of the candidate, accessibility of the item, and local industry and regional contexts.
Agents considered inactive, that are required for bulking, stabilising, colouring and flavouring the final product
Batch numbers can include:
Batch numbers can consist of any combination of numerals and digits as specified in standard operating procedures that can uniquely identify an individual product or batch for recording and identification purposes.
Materials, manufacturing equipment and packaging devices:
The range of materials, manufacturing equipment and packaging devices to be used is specified by the batch/work sheet
Equipment and machinery used in manufacturing may be disposable r non-disposable and may include:
Products with the required integrity as well as those whose integrity have been compromised eg. damaged, contaminated or deteriorated
Routine handling products and products requiring special handling eg. cytotoxics and its spill management, refrigerated and frozen items, light sensitive material and flammables
Product packing may include:
Bulk containers
Client ready units
Containers may include:
Small&large volume infusions bags
Eye droppers
Vials
Syringes
Miscellaneous individual client unit devices
Labels may include:
Typed
Written
Electronically produced
Quarantine period
Quarantine period may be defined as time taken to obtain confirmation of suitability of product/batch for human use.
Storage conditions may include:
Correct temperature
Humidity
Light
Secured
Ventilated
Ambient
Isolated
Correct storage of hazardous substances
Secure and safe storage for controlled drugs
Cleaning methods may include:
Swabbing
Washing
Wiping
Disinfecting
Special storage conditions may include:
Refrigeration
Inflammable store
Copy and paste from the following performance criteria to create an observation checklist for each task. When you have finished writing your assessment tool every one of these must have been addressed, preferably several times in a variety of contexts. To ensure this occurs download the assessment matrix for the unit; enter each assessment task as a column header and place check marks against each performance criteria that task addresses.
Observation Checklist
Tasks to be observed according to workplace/college/TAFE policy and procedures, relevant legislation and Codes of Practice
Yes
No
Comments/feedback
Identify the circumstances that require compounding of the product within a laminar flow hood/clean room or cytotoxic drug safety cabinet/cytotoxic suite or room or isolator
Confirm relevant legal, quality and hospital policy factors in sterile production
Follow correct dress code, safety and personal hygiene procedures and Personal Protective Equipment (PPE)
Maintain preparation areas at NCCTG requirements and Australian Standards for area classification
Clean work area and equipment correctly
Maintain inventory levels of materials and disposable equipment
Obtain and clarify the confirmed and formulated manufacturing order from pharmacist
Prepare production work sheet from formulated manufacturing order/master batch sheet
Interpret manufacture work sheet and assign appropriate product batch number
Check and set up compounding machinery or disposable equipment and any specialist equipment and clothing required for the compounding of sterile pharmaceutical products (e.g. cytotoxic spill cleaning kits)
Prepare labels and check number of labels generated
Apply an understanding of cytotoxic drugs and their basic pharmacology to the preparation of products
Apply an understanding of SHPA Standards for preparation of cytotoxic drugs and relevant State legislation
Make cytotoxic spill cleaning kits available in all production areas
Use specialist equipment and clothing for the safe handling and preparation of cytotoxic drugs
Identify exposure hazards and mitigation requirements related to cytotoxic drugs
Acquire all materials used in aseptic production according to stock levels and stock requisitioning procedures
Check materials to ensure they have been released from quarantine for use by authorised persons
Verify materials against manufacturing work sheet and record material batch numbers
Weigh and measure materials in designated weighing area
Allocate raw materials to appropriate manufacturing machinery, where applicable
Select appropriate types, size and features of containers and packaging in sterile manufacturing
Obtain appropriate authorisation/checks at designated points
Transfer raw materials, disposable equipment, required containers or packaging and covered work sheet to pre-production area
Follow hand washing, gowning and appropriate gloving procedures
Disinfect and transfer materials, disposable equipment and work sheet to sterile production area
Comply with NCCTG Guidelines for the Preparation of Pharmaceuticals in Hospitals and Australian Standards for operator safety when cleaning, setting up work station and transference of materials
Allocate approved bulk materials, intermediary products and containers to appropriate machinery / equipment where required
Incorporate materials according to batch documentation
Compound product according to method on manufacturing work sheet (e.g. aseptically transfer materials from one vessel to another) and in compliance with standard operating procedures for any measuring device or machinery use
Prepare cytotoxic products using procedures for handling cytotoxic drugs.
Work within the requirements of sterile areas, air locks, laminar flow hoods and cytotoxic drug safety cabinet / isolator
Operate specialist equipment and use specialist supplies in sterile production preparation
Obtain required authorisation/checks at designated points
Monitor product and adjust any necessary pharmaceutical/compounding to ensure product complies with work sheet specifications
Perform checking procedure and inspect finished product for deviations
Pack product using appropriate packaging devices/machinery as specified on the work sheet, and following approval from an authorised person
Label containers/units according to labelling specifications on the work sheet
Pack and label a retention sample and/or quality control sample if specified on the work sheet
Place product in quarantine area under appropriate storage conditions, where specified
Clean machinery and manufacturing area
Identify procedures for cleaning cytotoxic spills and the course of action taken after accidental contact with cytotoxic drugs and their safe disposal
Complete machinery and equipment records and/or logs
Reconcile the number of labels printed with the number used and discard excess. Note discrepancies in labels and documentation
Complete documentation and forward to appropriate person
Report discrepancies to an authorised person
Obtain final clearance from an authorised person
Perform environmental monitoring according to organisation requirements and report abnormal readings to an authorised person
Submit product sample and relevant documentation to quality control, where specified
Record and file product quality control assay results and manufacturing area environmental monitoring results
Store products according to manufacturing documentation
Obtain released product(s) from quarantine store
Pack released product(s) into appropriate delivery containers
Deliver product to store/dispensary by appropriate means, ensuring safe transport of cytotoxic products
Advise receipting area personnel of any special storage requirements
Complete and file records and/or work sheets
Forms
Assessment Cover Sheet
HLTPH415B - Conduct small-scale compounding of aseptic pharmaceutical products
Assessment task 1: [title]
Student name:
Student ID:
I declare that the assessment tasks submitted for this unit are my own work.
Student signature:
Result: Competent Not yet competent
Feedback to student
Assessor name:
Signature:
Date:
Assessment Record Sheet
HLTPH415B - Conduct small-scale compounding of aseptic pharmaceutical products
Student name:
Student ID:
Assessment task 1: [title] Result: Competent Not yet competent
(add lines for each task)
Feedback to student:
Overall assessment result: Competent Not yet competent