Unit of competency details

FDFPH2013A - Operate a tablet coating process (Release 1)


Usage recommendation:
Is superseded by and equivalent to FBPPHM3015 - Operate a tablet coating processUpdated to meet Standards for Training Packages Changes to performance criteria for clarity Code changed to reflect AQF alignment 17/Dec/2018
Supersedes FDFPHTC2B - Operate a tablet coating processUnit replaces earlier version. 30/Jan/2011

ReleaseRelease date
1 1 (this release) 31/Jan/2011


SchemeCodeClassification value
ASCED Module/Unit of Competency Field of Education Identifier 030399 Process And Resources Engineering, N.e.c.  

Classification history

SchemeCodeClassification valueStart dateEnd date
ASCED Module/Unit of Competency Field of Education Identifier 030399 Process And Resources Engineering, N.e.c.  03/Aug/2011 
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Modification History

Not applicable.

Unit Descriptor

Unit descriptor 

This unit of competency covers the skills and knowledge required to set up, operate and shut down the tablet coating process.

Application of the Unit

Application of the unit 

This unit has application in a pharmaceutical manufacturing environment. It typically targets the production worker responsible for applying basic operating principles to the operation and monitoring of a tablet coating process.

When batch or product changeover procedures are part of this work process, the procedures should be used to customise the application of this unit. Where more detailed changeovers are carried out, FDFOP2011A Conduct routine maintenance, should be considered.

Licensing/Regulatory Information

Not applicable.


Prerequisite units 

Employability Skills Information

Employability skills 

This unit contains employability skills.

Elements and Performance Criteria Pre-Content

Elements describe the essential outcomes of a unit of competency.

Performance criteria describe the performance needed to demonstrate achievement of the element. Where bold italicised text is used, further information is detailed in the required skills and knowledge section and the range statement. Assessment of performance is to be consistent with the evidence guide.

Elements and Performance Criteria



1. Prepare the tablet coating process for operation

1.1. Tablets and coating materials are confirmed and available to meet operating requirements

1.2. Cleaning and maintenance requirements and status are identified and confirmed

1.3. Machine components and related attachments are fitted and adjusted to meet operating requirements

1.4. Processing/operating parameters are entered as required to meet safety and production requirements

1.5. Equipment performance is checked and adjusted as required

1.6. Pre-start checks are carried out as required by workplace requirements

2. Operate and monitor the tablet coating process

2.1. The process is started and operated according to workplace procedures

2.2. Equipment is monitored to identify variation in operating conditions

2.3. Variation in equipment operation is identified and maintenance requirements are reported according to workplace reporting requirements

2.4. The process is monitored to confirm that coated tablets meet specifications

2.5. Spillages are reported and removed according to standard operating procedures (SOPs)

2.6. Out-of-specification product/process outcomes are identified, rectified and/or reported to maintain the process within specification

2.7. The work area is maintained according to housekeeping standards

2.8. Work is conducted according to environmental standards

2.9. Workplace records are maintained according to workplace recording requirements

3. Shut down the tablet coating process

3.1. End-of-batch procedures are completed in accordance with batch instructions and SOPs

3.2. The process is shut down according to workplace procedures

3.3. Maintenance requirements are identified and reported according to workplace reporting requirements

Required Skills and Knowledge


This section describes the skills and knowledge required for this unit.

Required skills 

Ability to :

  • access workplace information to identify tablet coating process requirements
  • select, fit and use personal protective clothing and/or equipment
  • confirm supply of necessary tablets, coating materials and services to the tablet coating process
  • prepare coating materials according to specification
  • conduct pre-start checks on coating application equipment, such as inspecting equipment condition to identify any signs of wear, selecting appropriate settings and/or related parameters, cancelling isolation or lock outs as required, confirming line clearance and cleaning status, ensuring equipment is correctly configured for processing requirements, positioning sensors and controls correctly, ensuring any scheduled maintenance has been carried out, and confirming that all safety guards are in place and operational
  • start, operate, monitor and adjust the tablet coating process equipment to achieve required outcomes, including monitoring control points and conducting inspections as required to confirm process remains within specification, such as:
  • pan preparation/coating
  • coating addition rate
  • addition/dosing of materials
  • drying air temperature and flow
  • addition of polishing agent/gum as required
  • take corrective action in response to out-of-specification results
  • monitor supply and flow of materials to and from the tablet coating process
  • respond to and/or report equipment failure within level of responsibility
  • locate emergency stop functions on equipment
  • follow isolation and lock out/tag out procedures as required to take the tablet coating process and related equipment off-line in preparation for cleaning and/or maintenance within level of responsibility
  • demonstrate batch/product changeovers
  • follow end-of-batch procedures, including line clearance and cleaning, yield calculation, materials reconciliation and product labelling
  • complete workplace records as required
  • maintain work area to meet housekeeping standards
  • use process control systems according to enterprise procedures
  • collect samples and conduct tests according to enterprise procedures
  • conduct routine maintenance according to enterprise procedures
  • use oral communication skills/language competence to fulfil the job role as specified by the organisation, including questioning, active listening, asking for clarification and seeking advice from supervisor
  • work cooperatively within a culturally diverse workforce

Required knowledge 

Knowledge of :

  • purpose and basic principles of the tablet coating process, such as tablet preparation/conditioning procedures and requirements, coating preparation and the stages in the coating process
  • basic operating principles of equipment, such as main equipment components, status and purpose of guards, equipment operating capacities and applications, and the purpose and location of sensors and related feedback instrumentation
  • services required and action to take if services are not available
  • the flow of the tablet coating process and the effect of outputs on downstream pharmaceutical processes
  • stages and changes which occur during tablet coating
  • types of materials used in preparation of coatings and related handling/segregation requirements
  • quality characteristics and legal requirements to be achieved by the tablet coating process
  • effect of tablet coating process on the end product
  • quality requirements of materials and effect of variation on tablet coating process performance
  • operating requirements and parameters and corrective action required where operation is outside specified operating parameters
  • typical equipment faults and related causes, including signs and symptoms of faulty equipment and early warning signs of potential problems
  • methods used to monitor the tablet coating process, such as inspecting, measuring and testing as required by the process
  • inspection or test points (control points) in the tablet coating process and the related procedures and recording requirements
  • Good Manufacturing Practice (GMP) requirements associated with the tablet coating process and related control measures
  • common causes of variation and corrective action required
  • product/process changeover procedures and responsibilities
  • occupational health and safety (OHS) hazards and controls, including the limitations of protective clothing and equipment relevant to the work process
  • end-of-batch procedures, including procedures for calculating yield, materials reconciliation and action required if yield/reconciliation is not within prescribed limits, and product labelling responsibilities and procedures
  • requirements of different shutdowns as appropriate to the process and workplace production requirements, including emergency and routine shutdowns and procedures to follow in the event of a power outage
  • line clearance, cleaning and sanitation procedures
  • isolation, lock out and tag out procedures and responsibilities
  • procedures and responsibility for reporting production and performance information
  • environmental issues and controls relevant to the tablet coating process, including waste collection and handling procedures related to the process
  • basic operating principles of process control, where relevant, including the relationship between control panels and systems and the physical equipment
  • sampling and testing associated with process monitoring and control where relevant
  • routine maintenance procedures where relevant

Evidence Guide


The Evidence Guide provides advice on assessment and must be read in conjunction with the performance criteria, required skills and knowledge, range statement and the Assessment Guidelines for the Training Package.

Overview of assessment 

Assessment must be carried out in a manner that recognises the cultural and literacy requirements of the assessee and is appropriate to the work performed. Competence in this unit must be achieved in accordance with food safety standards and regulations.

Critical aspects for assessment and evidence required to demonstrate competency in this unit 

Evidence of ability to:

  • conduct pre-start checks on machinery used for coating tablets
  • start, operate, monitor and adjust process equipment to achieve required quality outcomes
  • take corrective action in response to typical faults and inconsistencies
  • complete workplace records as required
  • apply safe work practices and identify OHS hazards and controls
  • safely shut down equipment
  • apply food safety procedures to work practices.

Context of and specific resources for assessment 

Assessment must occur in a real or simulated workplace where assessee has access to:

  • personal protective clothing and equipment
  • work procedures, including advice on safe work practices, GMP, quality and environmental requirements
  • information on equipment capacity and operating parameters
  • production schedule/batch instructions
  • specifications, control points and processing parameters
  • tablet coating process and related equipment and services
  • materials required for the tablet coating process, including tablets and coating materials
  • sampling schedules and test procedures and equipment as required
  • documentation and recording requirements and procedures
  • cleaning procedures, materials and equipment as required.

Method of assessment 

This unit should be assessed together with core units and other units of competency relevant to the function or work role. Examples could be:

  • FDFOP2003A Clean equipment in place
  • FDFOP2004A Clean and sanitise equipment
  • FDFOP2011A Conduct routine maintenance
  • FDFOP2013A Apply sampling procedures
  • FDFOP2030A Operate a process control interface
  • MSL973001A Perform basic tests.

Guidance information for assessment 

To ensure consistency in one's performance, competency should be demonstrated on more than one occasion over a period of time in order to cover a variety of circumstances, cases and responsibilities, and where possible, over a number of assessment activities.

Range Statement


The range statement relates to the unit of competency as a whole. It allows for different work environments and situations that may affect performance. Bold italicised wording, if used in the performance criteria, is detailed below. 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) may also be included.

Policies and procedures 

Work is carried out according to company policies and procedures, regulatory and licensing requirements, legislative requirements, and industrial awards and agreements

Legislative requirements 

Legislative requirements are typically reflected in procedures and specifications. Legislation relevant to this industry includes:

  • relevant Good Manufacturing Practice (GMP) codes
  • the Therapeutic Goods Act and/or other relevant legislation
  • legislation covering environmental management, OHS, anti-discrimination and equal opportunity

Workplace information 

Workplace information may include:

  • SOPs
  • specifications
  • production schedules and instructions
  • manufacturers' advice
  • standard forms and reports

Tablet coating equipment 

Tablet coating equipment may include:

  • coating preparation (homogenisers, blenders and mixers)
  • heat exchangers
  • pumps
  • jacketed spray guns/heads
  • coating pans
  • polishing pans
  • holding tanks

Tablet coating processes 

Tablet coating processes may include:

  • sugar coating
  • film coating


Materials used in the sugar coating process include:

  • purified water
  • cellulose derivatives
  • polyvinal
  • gums
  • sugar

Materials used in film coating include:

  • purified water
  • cellulose derivatives


Work may involve:

  • exposure to dangerous and hazardous substances

Operation of equipment and processes 

Operation of equipment and processes may require:

  • the use of process control panels and systems

Shutdown procedures 

Shutdown procedures may include:

  • cleaning (in some cases cleaning may be carried out by a dedicated cleaning crew)


Services may need to be confirmed. These depend on the nature of the process. Typical examples include:

  • power
  • steam
  • water
  • vacuum
  • gases
  • compressed and instrumentation air

Unit Sector(s)

Unit sector 

Pharmaceutical manufacturing

Competency field

Competency field 

Co-requisite units

Co-requisite units