Unit of Competency Mapping – Information for Teachers/Assessors – Information for Learners

FBPPHM3004 Mapping and Delivery Guide
Clean and sanitise facilities and equipment

Version 1.0
Issue Date: May 2024


Qualification -
Unit of Competency FBPPHM3004 - Clean and sanitise facilities and equipment
Description
Employability Skills
Learning Outcomes and Application This unit of competency describes the skills and knowledge required to plan, prepare, clean and sanitise processing facilities and equipment in a pharmaceutical manufacturing facility.The unit applies to individuals who apply Good Manufacturing Practice (GMP) requirements and operating principles to the cleaning and sanitising of facilities and equipment. Individuals work under broad direction and take responsibility for their own work. No occupational licensing, legislative or certification requirements apply to this unit at the time of publication.
Duration and Setting X weeks, nominally xx hours, delivered in a classroom/online/blended learning setting.
Prerequisites/co-requisites
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: Plan and prepare to clean pharmaceutical processing areas and equipment
  • Obtain cleaning task requirements, including job specifications and workplace procedures for sampling and testing cleaning outcomes
  • Identify surfaces and soil and dirt types and select appropriate cleaning techniques
  • Select and prepare cleaning chemicals required for job
  • Select and check cleaning equipment and consumables for serviceability and compliance with cleaning and sanitation requirements of GMP cleaning program
  • Rectify or report faults before starting work
  • Confirm services are available and ready for operation
  • Source and fit personal protective equipment (PPE) according to procedures for health and safety in the workplace
  • Obtain cleaning consumables to meet anticipated usage patterns
  • Select and install signs and barricades according workplace procedures
  • Set the plant for automated cleaning cycle or initiate a manual clean
       
Element: Remove waste
  • Collect and dispose of waste according to procedures and legislative requirements for the environment and health and safety in the workplace
  • Clean and sanitise rubbish bins and insert new replacement bin liners according to workplace procedures
       
Element: Clean and sanitise pharmaceutical processing surfaces
  • Change status label of area and equipment and check status prior to cleaning
  • Remove loose dirt and debris from pharmaceutical processing surfaces prior to applying cleaning treatment
  • Follow cleaning steps according to workplace procedures
  • Apply cleaning chemicals to pharmaceutical surfaces according to manufacturers' specifications and workplace procedures
  • Thoroughly rinse and dry surfaces according to workplace procedures
  • Apply chemical disinfectants and sanitisers to surfaces according to workplace procedures
  • Report practices inconsistent with GMP according to workplace procedures
       
Element: Clean and sanitise pharmaceutical processing equipment
  • Clean and sanitise processing equipment according to GMP requirements and workplace procedures
  • Monitor the cleaning process and identify and report deviations from job specifications according to workplace procedures
  • Inspect and confirm equipment cleanliness status against acceptance criteria and take appropriate action to rectify non-conformances
  • Confirm relevant sampling or testing methods including sampling or testing points, types of samples and measurements requirements
  • Take, collect, store and transport samples according to sampling plan, relevant methods and standards
  • Return equipment to operating order
  • Record and certify data and information about equipment cleaning and sanitising, including cleaning status, sampling and testing according to workplace procedures and GMP requirements
       
Element: Return plant to operating condition
  • Remove signs and barricades according to workplace procedures and work health and safety
  • Clean, check and store cleaning equipment and PPE according to manufacturers' specifications, environmental and workplace health and safety requirements
  • Store and dispose of unused chemicals according to manufacturers' specifications, and workplace health and safety requirements
  • Order and replenish cleaning consumables
  • Document tasks completed according to workplace procedures
       

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 section specifies different work environments and conditions that may affect performance. Essential operating conditions that may be present (depending on the work situation, needs of the candidate, accessibility of the item, and local industry and regional contexts) are included.

PPE must include:

one of the following:

protective gown

scrubs

smock

statcoat

cleanroom coverall

disposable coverall

plus all of the following:

disposable overshoes or cleanroom boots

hair net

goggles or safety glasses.

Waste must include:

cleaning material or product waste

hazardous waste

general processing and laboratory waste.

Monitoring of the cleaning process must include:

chemical strength

cycle time(s)

temperature

contact time

rinse water quality.

Sampling or testing methods must include:

visual inspection

pH tests of final rinse water

swabbing of equipment surfaces for presence of contamination.

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
Obtain cleaning task requirements, including job specifications and workplace procedures for sampling and testing cleaning outcomes 
Identify surfaces and soil and dirt types and select appropriate cleaning techniques 
Select and prepare cleaning chemicals required for job 
Select and check cleaning equipment and consumables for serviceability and compliance with cleaning and sanitation requirements of GMP cleaning program 
Rectify or report faults before starting work 
Confirm services are available and ready for operation 
Source and fit personal protective equipment (PPE) according to procedures for health and safety in the workplace 
Obtain cleaning consumables to meet anticipated usage patterns 
Select and install signs and barricades according workplace procedures 
Set the plant for automated cleaning cycle or initiate a manual clean 
Collect and dispose of waste according to procedures and legislative requirements for the environment and health and safety in the workplace 
Clean and sanitise rubbish bins and insert new replacement bin liners according to workplace procedures 
Change status label of area and equipment and check status prior to cleaning 
Remove loose dirt and debris from pharmaceutical processing surfaces prior to applying cleaning treatment 
Follow cleaning steps according to workplace procedures 
Apply cleaning chemicals to pharmaceutical surfaces according to manufacturers' specifications and workplace procedures 
Thoroughly rinse and dry surfaces according to workplace procedures 
Apply chemical disinfectants and sanitisers to surfaces according to workplace procedures 
Report practices inconsistent with GMP according to workplace procedures 
Clean and sanitise processing equipment according to GMP requirements and workplace procedures 
Monitor the cleaning process and identify and report deviations from job specifications according to workplace procedures 
Inspect and confirm equipment cleanliness status against acceptance criteria and take appropriate action to rectify non-conformances 
Confirm relevant sampling or testing methods including sampling or testing points, types of samples and measurements requirements 
Take, collect, store and transport samples according to sampling plan, relevant methods and standards 
Return equipment to operating order 
Record and certify data and information about equipment cleaning and sanitising, including cleaning status, sampling and testing according to workplace procedures and GMP requirements 
Remove signs and barricades according to workplace procedures and work health and safety 
Clean, check and store cleaning equipment and PPE according to manufacturers' specifications, environmental and workplace health and safety requirements 
Store and dispose of unused chemicals according to manufacturers' specifications, and workplace health and safety requirements 
Order and replenish cleaning consumables 
Document tasks completed according to workplace procedures 

Forms

Assessment Cover Sheet

FBPPHM3004 - Clean and sanitise facilities and equipment
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

FBPPHM3004 - Clean and sanitise facilities and equipment

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

Assessor name:

Signature:

Date:

Student signature:

Date: