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Evidence Guide: FBPPHM3004 - Clean and sanitise facilities and equipment

Student: __________________________________________________

Signature: _________________________________________________

Tips for gathering evidence to demonstrate your skills

The important thing to remember when gathering evidence is that the more evidence the better - that is, the more evidence you gather to demonstrate your skills, the more confident an assessor can be that you have learned the skills not just at one point in time, but are continuing to apply and develop those skills (as opposed to just learning for the test!). Furthermore, one piece of evidence that you collect will not usualy demonstrate all the required criteria for a unit of competency, whereas multiple overlapping pieces of evidence will usually do the trick!

From the Wiki University

 

FBPPHM3004 - Clean and sanitise facilities and equipment

What evidence can you provide to prove your understanding of each of the following citeria?

Plan and prepare to clean pharmaceutical processing areas and equipment

  1. Obtain cleaning task requirements, including job specifications and workplace procedures for sampling and testing cleaning outcomes
  2. Identify surfaces and soil and dirt types and select appropriate cleaning techniques
  3. Select and prepare cleaning chemicals required for job
  4. Select and check cleaning equipment and consumables for serviceability and compliance with cleaning and sanitation requirements of GMP cleaning program
  5. Rectify or report faults before starting work
  6. Confirm services are available and ready for operation
  7. Source and fit personal protective equipment (PPE) according to procedures for health and safety in the workplace
  8. Obtain cleaning consumables to meet anticipated usage patterns
  9. Select and install signs and barricades according workplace procedures
  10. Set the plant for automated cleaning cycle or initiate a manual clean
Obtain cleaning task requirements, including job specifications and workplace procedures for sampling and testing cleaning outcomes

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Identify surfaces and soil and dirt types and select appropriate cleaning techniques

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Select and prepare cleaning chemicals required for job

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Select and check cleaning equipment and consumables for serviceability and compliance with cleaning and sanitation requirements of GMP cleaning program

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Rectify or report faults before starting work

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Confirm services are available and ready for operation

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Source and fit personal protective equipment (PPE) according to procedures for health and safety in the workplace

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Obtain cleaning consumables to meet anticipated usage patterns

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Select and install signs and barricades according workplace procedures

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Set the plant for automated cleaning cycle or initiate a manual clean

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Remove waste

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

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Clean and sanitise rubbish bins and insert new replacement bin liners according to workplace procedures

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Clean and sanitise pharmaceutical processing surfaces

  1. Change status label of area and equipment and check status prior to cleaning
  2. Remove loose dirt and debris from pharmaceutical processing surfaces prior to applying cleaning treatment
  3. Follow cleaning steps according to workplace procedures
  4. Apply cleaning chemicals to pharmaceutical surfaces according to manufacturers' specifications and workplace procedures
  5. Thoroughly rinse and dry surfaces according to workplace procedures
  6. Apply chemical disinfectants and sanitisers to surfaces according to workplace procedures
  7. Report practices inconsistent with GMP according to workplace procedures
Change status label of area and equipment and check status prior to cleaning

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Remove loose dirt and debris from pharmaceutical processing surfaces prior to applying cleaning treatment

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Follow cleaning steps according to workplace procedures

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Apply cleaning chemicals to pharmaceutical surfaces according to manufacturers' specifications and workplace procedures

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Thoroughly rinse and dry surfaces according to workplace procedures

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Apply chemical disinfectants and sanitisers to surfaces according to workplace procedures

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Report practices inconsistent with GMP according to workplace procedures

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Clean and sanitise pharmaceutical processing equipment

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

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Monitor the cleaning process and identify and report deviations from job specifications according to workplace procedures

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Inspect and confirm equipment cleanliness status against acceptance criteria and take appropriate action to rectify non-conformances

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Confirm relevant sampling or testing methods including sampling or testing points, types of samples and measurements requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Take, collect, store and transport samples according to sampling plan, relevant methods and standards

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Return equipment to operating order

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Record and certify data and information about equipment cleaning and sanitising, including cleaning status, sampling and testing according to workplace procedures and GMP requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Return plant to operating condition

  1. Remove signs and barricades according to workplace procedures and work health and safety
  2. Clean, check and store cleaning equipment and PPE according to manufacturers' specifications, environmental and workplace health and safety requirements
  3. Store and dispose of unused chemicals according to manufacturers' specifications, and workplace health and safety requirements
  4. Order and replenish cleaning consumables
  5. Document tasks completed according to workplace procedures
Remove signs and barricades according to workplace procedures and work health and safety

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Clean, check and store cleaning equipment and PPE according to manufacturers' specifications, environmental and workplace health and safety requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Store and dispose of unused chemicals according to manufacturers' specifications, and workplace health and safety requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Order and replenish cleaning consumables

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Document tasks completed according to workplace procedures

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Assessed

Teacher: ___________________________________ Date: _________

Signature: ________________________________________________

Comments:

 

 

 

 

 

 

 

 

Instructions to Assessors

Required Skills and Knowledge
Range Statement

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.