FBPPHM3004 - Clean and sanitise facilities and equipment
Assessor Resource
FBPPHM3004 Clean and sanitise facilities and equipment
Assessment tool
Version 1.0 Issue Date: May 2024
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.
You may want to include more information here about the target group and the purpose of the assessments (eg formative, summative, recognition)
Submission Requirements
List each assessment task's title, type (eg project, observation/demonstration, essay, assingnment, 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