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 an encapsulation process and equipment. This person would typically work within defined Good Manufacturing Practice (GMP) programs and procedures.

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.

ELEMENT

PERFORMANCE CRITERIA

1. Prepare the encapsulation process for operation

1.1. 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 encapsulation process

2.1. The encapsulation 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 capsules meet specifications

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

2.6. The work area is maintained according to housekeeping standards

2.7. Work is conducted according to environmental standards

2.8. Spillages are reported and removed according to standard operating procedures

2.9. Workplace records are maintained according to workplace recording requirements

3. Shut down the encapsulation process

3.1. End-of-batch procedures are completed in accordance with batch instructions and standard operating procedures (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

Ability to:

access workplace information to identify production requirements for the encapsulation process

select, fit and use personal protective clothing and/or equipment

confirm supply of necessary materials and services to the encapsulation process

conduct pre-start checks, 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 and that 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

verify raw materials with batch instructions

start, operate, monitor and adjust encapsulation process equipment to achieve required outcomes, including monitoring control points and conducting inspections as required to confirm process remains within specification, such as:

flow rates/quantity

product quality

take corrective action in response to out-of-specification results, such as adjusting the flow rates

monitor supply and flow of materials to and from the encapsulation 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 encapsulation 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 encapsulation 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

types of raw materials used in the encapsulation process and related handling/segregation requirements, such as handling hazardous goods

stages and changes which occur during encapsulation

quality characteristics and legal requirements to be achieved by the encapsulation process

the flow of the encapsulation process and the effect of outputs on downstream pharmaceutical processes

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 encapsulation process, such as inspecting, measuring and testing as required by the process

inspection or test points (control points) in the encapsulation process and the related procedures and recording requirements

GMP requirements associated with the encapsulation 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 encapsulation 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 encapsulation 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

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 equipment used for encapsulation

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

encapsulation process and related equipment and services

materials required for the encapsulation process

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.

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

Encapsulation equipment and accessories

Encapsulation equipment and accessories may include:

semi-automatic filling machines

intermittent filling machines

continuous filling machines

augers

stirrers

hoppers

post-ejection accessories

Encapsulation filling methods

Encapsulation filling methods may include:

powder filling

pellet filling

solid filling

liquid filling

Stock

Stock for the encapsulation process:

is supplied from the granulation process and ingredients/raw materials from the dispensing process

Capsule defects

Capsule defects may include:

short body

short cap

rough cut,

collet pinches

punched ends

long body or cap

split

wrinkles

specks

star ends

dirt

strings

bubbles

print errors/defects

Work

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

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

Pharmaceutical manufacturing

This unit contains employability skills.