Application
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. |
Elements and Performance Criteria
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
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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 |
Evidence Required
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. |
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 |
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 |
Sectors
Unit sector | Pharmaceutical manufacturing |
Employability Skills
This unit contains employability skills. |
Licensing Information
Not applicable.