Elements

Performance Criteria

Elements describe the essential outcomes.

Performance criteria describe the performance needed to demonstrate achievement of the element.

1. Plan and prepare to clean pharmaceutical processing areas and equipment

1.1 Obtain cleaning task requirements, including job specifications and workplace procedures for sampling and testing cleaning outcomes

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

1.3 Select and prepare cleaning chemicals required for job

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

1.5 Rectify or report faults before starting work

1.6 Confirm services are available and ready for operation

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

1.8 Obtain cleaning consumables to meet anticipated usage patterns

1.9 Select and install signs and barricades according workplace procedures

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

2. Remove waste

2.1 Collect and dispose of waste according to procedures and legislative requirements for the environment and health and safety in the workplace

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

3. Clean and sanitise pharmaceutical processing surfaces

3.1 Change status label of area and equipment and check status prior to cleaning

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

3.3 Follow cleaning steps according to workplace procedures

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

3.5 Thoroughly rinse and dry surfaces according to workplace procedures

3.6 Apply chemical disinfectants and sanitisers to surfaces according to workplace procedures

3.7 Report practices inconsistent with GMP according to workplace procedures

4. Clean and sanitise pharmaceutical processing equipment

4.1 Clean and sanitise processing equipment according to GMP requirements and workplace procedures

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

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

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

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

4.6 Return equipment to operating order

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

5. Return plant to operating condition

5.1 Remove signs and barricades according to workplace procedures and work health and safety

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

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

5.4 Order and replenish cleaning consumables

5.5 Document tasks completed according to workplace procedures

Skill

Description

Reading

Identify and follow signs, symbols, checklists, production schedules, cleaning schedules and other technical information relevant to cleaning and sanitising facilities and equipment

Identify and follow workplace information, specifications and safety data sheets (SDS)

Identify and interpret GMP information relevant to cleaning and sanitising facilities and equipment

Writing

Complete checklists, standard forms and reports relating to practices inconsistent with GMP

Oral communication

Use clear language to report contamination risks and practices inconsistent with GMP

Participate in verbal exchanges to respond to questions and clarify information

Numeracy

Interpret measurements and numerical symbols in SDSs

Record data and information using mathematical symbols and conventions

Navigate the world of work

Recognise and follow workplace requirements, including safety requirements and GMP, associated with own role and area of responsibility

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.