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Unit of competency details

FBPPHM3015 - Operate a tablet coating process (Release 1)

Summary

Usage recommendation:
Current
Mapping:
MappingNotesDate
Supersedes and is equivalent to FDFPH2013A - 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

Release Status:
Current
Releases:
ReleaseRelease date
1 1 (this release) 18/Dec/2018


Classifications

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.  18/Dec/2018 
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Unit Of competency

Modification History

Release 

Comments 

Release 1

This version released with FBP Food, Beverage and Pharmaceutical Training Package Version 2.0.

Application

This unit of competency describes the skills and knowledge required to set up, operate, adjust and shut down a tablet coating process in a pharmaceutical manufacturing facility.

The unit applies to individuals who apply Good Manufacturing Practice (GMP) and operating principles to the tablet coating process. 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.

Pre-requisite Unit

Nil

Unit Sector

Pharmaceutical (PHM)

Elements and Performance Criteria

Elements 

Performance Criteria 

Elements describe the essential outcomes.

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

1. Prepare the tablet coating process for operation

1.1 Confirm tablets, coating materials and equipment are available and meet production requirements

1.2 Select and fit personal protective equipment and contamination prevention clothing according to workplace procedures

1.3 Fit and adjust machine components and attachments according to production requirements and equipment operation and maintenance manual

1.4 Enter processing and operating parameters according to safety and production requirements

1.5 Conduct pre-start checks according to workplace requirements

2. Operate and monitor the tablet coating process

2.1 Start up and monitor tablet coating process to confirm specifications are within required limits

2.2 Identify and report out of limit coated tablet products or processes according to workplace procedures

2.3 Maintain work area according to workplace cleaning standards

2.4 Conduct process according to safety and environmental requirements

2.5 Contain, remove and report spillages according to workplace procedures

2.6 Complete documentation according to workplace procedures

3. Shut down the tablet coating process

3.1 Confirm the workplace procedures for shutting down the process

3.2 Complete end-of-batch procedures according to batch instructions and workplace procedures

3.3 Safely shut down the process

3.4 Complete records according to workplace procedures

Foundation Skills

This section describes those language, literacy, numeracy and employment skills that are essential for performance in this unit of competency but are not explicit in the performance criteria.

Skill 

Description 

Reading

  • Identify relevant information from workplace documentation and interpret requirements for the tablet coating process

Writing

  • Complete workplace documentation using appropriate language and in required format

Numeracy

  • Confirm type and number of tablets to be coated meet batch requirements
  • Interpret specifications for coating addition rate and drying air temperature and flow

Navigate the world of work

  • Identify workplace procedures relevant to own role

Interact with others

  • Report operational and safety information to relevant personnel using required communication method

Get the work done

  • Plan, organise and implement tasks required to achieve production outcomes
  • Use problem-solving skills to analyse product and process faults and decide on appropriate action

Range of Conditions

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.

Pre-start checks must include:

  • carrying out required area or line clearances
  • inspecting equipment condition to identify signs of wear
  • confirming all safety equipment is in place and operational
  • confirming that equipment is clean or sanitised
  • confirming that equipment is correctly configured for processing requirements.

Unit Mapping Information

Code and title current version 

Code and title previous version 

Comments 

Equivalence status 

FBPPHM3015 Operate a tablet coating process

FDFPH2013A Operate a tablet coating process

Updated to meet Standards for Training Packages

Changes to performance criteria for clarity

Code changed to reflect AQF alignment

Equivalent unit

Links

Companion Volume Implementation Guides are found in VETNet: - https://vetnet.gov.au/Pages/TrainingDocs.aspx?q=78b15323-cd38-483e-aad7-1159b570a5c4

 

Assessment requirements

Modification History

Release 

Comments 

Release 1

This version released with FBP Food, Beverage and Pharmaceutical Training Package Version 2.0.

Performance Evidence

An individual demonstrating competency in this unit must satisfy all the elements and performance criteria of this unit.

There must be evidence that the individual has safely operated at least one tablet coating process, including:

  • accessed workplace information to confirm production requirements for the tablet coating process
  • confirmed supply of necessary tablets, coating materials and services for the tablet coating process
  • selected, fitted and correctly used personal protective equipment and contamination prevention clothing
  • conducted pre-start checks required for the safe operation of the tablet coating process equipment, including:
  • carrying out required area or line clearances
  • inspecting equipment condition to identify signs of wear
  • confirming all safety equipment is in place and operational
  • confirming that equipment is clean or sanitised
  • confirming that equipment is correctly configured for processing requirements
  • started, operated, monitored and adjusted the tablet coating process to achieve required outcomes
  • conducted in-process control checks to confirm the process remains within limits
  • sampled and inspected tablets for conformance to specifications
  • taken corrective action in response to a non-conformance
  • followed end-of-batch procedures, including:
  • line clearance and cleaning
  • yield calculation
  • materials reconciliation
  • product labelling
  • safely shut down the process according to workplace procedures
  • cleaned and maintained work area to meet workplace cleaning standards and environmental requirements
  • completed records according to workplace procedures.

Knowledge Evidence

An individual must be able to demonstrate the knowledge required to perform the tasks outlined in the elements and performance criteria of this unit. This includes knowledge of:

  • stages of the tablet coating process, including:
  • the purpose, methods and outcomes of each stage
  • control points
  • quality characteristics to be met by the tablet coating process
  • stages and changes which occur during tablet coating
  • effects of tablet coating process on the end product
  • types of materials used in preparation of coatings and related handling and segregation requirements
  • flow of the tablet coating process and the effect of outputs on downstream pharmaceutical processes
  • basic operating principles of equipment, requirements and parameters of tablet coating equipment, including:
  • main equipment components, operating capacities and applications
  • typical equipment faults and related causes, including signs and symptoms of faulty equipment and early warning signs of potential problems
  • status and purpose of guards
  • the purpose and location of sensors and related feedback instrumentation
  • corrective actions required where operation is outside of specified parameters
  • functions and the limitations of personal protective equipment and contamination prevention clothing
  • pre-start checks requirements, including:
  • carrying out required area or line clearances
  • inspecting equipment condition to identify signs of wear
  • confirming all safety equipment is in place and operational
  • confirming that equipment is clean or sanitised
  • confirming that equipment is correctly configured for processing requirements
  • methods used to monitor the tablet coating process, including:
  • inspecting
  • measuring
  • testing
  • product and process changeover procedures and responsibilities
  • end-of-batch procedures, including:
  • calculating yield
  • material reconciliation
  • product labelling responsibilities and procedures
  • requirements of different shutdowns, including:
  • emergency and routine shutdowns
  • procedures to follow in the event of a power outage
  • line clearance procedures, including cleaning and sanitation procedures
  • isolation, lock out and tag out procedures and responsibilities
  • operating principles of process control, including the relationship between control panels and systems and the physical equipment
  • Good Manufacturing Practice (GMP) requirements associated with a tablet coating process and related control measures
  • environmental issues and controls relevant to the tablet coating process, including waste collection and handling procedures
  • requirements for completion of workplace documentation.

Assessment Conditions

Assessment of skills must take place under the following conditions:

  • physical conditions:
  • a pharmaceutical manufacturing workplace or an environment that accurately represents workplace conditions
  • resources, equipment and materials:
  • personal protective equipment and contamination prevention clothing
  • tablet coating process equipment
  • materials required for the tablet coating process, including tablets, coating materials and labels
  • test equipment
  • cleaning materials and equipment associated with tablet coating process
  • record keeping system
  • specifications:
  • batch instructions including product specifications, control points and processing parameters
  • recording requirements and procedures
  • workplace documentation relating to tablet coating process and procedures that comply with GMP requirements
  • sampling schedules and test procedures
  • cleaning procedures associated with tablet coating process.

Assessors of this unit must satisfy the requirements for assessors in applicable vocational education and training legislation, frameworks and/or standards.

Links

Companion Volume Implementation Guides are found in VETNet: - https://vetnet.gov.au/Pages/TrainingDocs.aspx?q=78b15323-cd38-483e-aad7-1159b570a5c4