Assessment Requirements for FBPPHM3006 Operate an extraction process

Release: 2

Assessment Requirements for FBPPHM3006 Operate an extraction process

Modification History

Release	Comments
Release 2	This version released with FBP Food, Beverage and Pharmaceutical Training Package Version 5.0.
Release 1	This version released with FBP Food, Beverage and Pharmaceutical Training Package Version 2.0.

Performance Evidence

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

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

confirmed production requirements and related facilities, storage and equipment

correctly gown using Standard Operating Procedures for the operations performed batch and product changeovers, including line clearance procedures

performed batch and product changeovers, including line clearance procedures

conducted pre-start checks required for the safe operation of the extraction process, including:

carried out required area or line clearances

inspected equipment condition to identify signs of wear

checked all safety equipment in place and operational

checked equipment clean or sanitised

checked equipment correctly configured for processing requirements

started, operated, monitored and adjusted a process to achieve required outcomes

conducted in-process control checks to confirm the process remains within limits

inspected product for defects

taken corrective action in response to a non-conformance

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 extraction process, including:

the purpose, methods and outcomes of each stage

the effect of material density on filtration

packing processes required for different types of materials

basic operating principles, requirements and parameters of extraction process 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

corrective actions required where operation is outside specified operating parameters

line clearance procedures, including procedures for clearing feed lines

workplace health and safety hazards, risks and controls relevant to an extraction process, including:

use of solvents

functions and limitations of personal protective equipment and contamination prevention clothing

pre-start check requirements, including:

required area or line clearances

equipment condition to identify signs of wear

safety equipment in place and operational

equipment clean or sanitised

equipment correctly configured for processing requirements

methods used to monitor extraction process, including:

inspecting

measuring

testing

calculating yields

quality requirements of materials and the effect of variations on the extraction process

product and process specifications, procedures and operating parameters for different products and materials

contamination risks associated with the extraction process

common causes of out-of-specification product or process and corrective actions required

extraction process shutdown and changeover procedures and responsibilities

Good Manufacturing Practice (GMP) requirements associated with an extraction process and related control measures

environmental issues and controls relevant to the extraction process, including waste collection and handling procedures

requirements for completion of workplace documentation.

Assessment Conditions

Assessment of the skills in this unit of competency 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

extraction solvents, material and equipment

cleaning materials and equipment associated with an extraction process

record keeping system

specifications:

product and intermediate product specifications, control points and processing parameters

recording requirements and procedures in accordance with Good Documentation Practice

workplace documentation relating to an extraction process and procedures that comply with GMP requirements

cleaning procedures associated with an extraction 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