Unit of Competency Mapping – Information for Teachers/Assessors – Information for Learners

FBPPHM3007 Mapping and Delivery Guide
Operate a separation process using chromatography

Version 1.0
Issue Date: May 2024


Qualification -
Unit of Competency FBPPHM3007 - Operate a separation process using chromatography
Description
Employability Skills
Learning Outcomes and Application This unit of competency describes the skills and knowledge required to set up, operate, adjust and shut down a chromatography separation process in a pharmaceutical manufacturing facility.The unit applies to individuals who use Good Manufacturing Practice (GMP) and operating principles in the chromatography separation 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.
Duration and Setting X weeks, nominally xx hours, delivered in a classroom/online/blended learning setting.
Prerequisites/co-requisites
Competency Field
Development and validation strategy and guide for assessors and learners Student Learning Resources Handouts
Activities
Slides
PPT
Assessment 1 Assessment 2 Assessment 3 Assessment 4
Elements of Competency Performance Criteria              
Element: Prepare chromatography equipment for operation
  • Identify production requirements from workplace documentation
  • Confirm materials meet production requirements
  • Confirm required facilities, storage, equipment and personnel are available
  • Select and fit personal protective equipment and contamination prevention clothing according to workplace procedures
  • Clean, assemble and adjust equipment according to workplace procedures and operation and maintenance manual
  • Set equipment components and related instrumentation to meet production requirements
  • Conduct pre-start checks according to workplace procedures
  • Complete equipment status reports according to workplace procedures
       
Element: Prepare samples and load products
  • Conduct pre-sampling tests and interpret test results to confirm column operation
  • Identify and report out of limit test results according to workplace procedures
  • Load product into columns according to specifications and production requirements
       
Element: Operate and monitor separation process
  • Start up and monitor separation process to confirm process cycles occur in correct sequence according to specifications and production requirements
  • Identify and report out of limit products or processes according to workplace procedures
  • Confirm separation of solution meets specifications
  • Conduct process according to safety and environmental requirements
  • Complete documentation according to workplace requirements
       
Element: Shut down separation process
  • Confirm the workplace procedures for shutting down the process
  • Safely shut down the process
  • Complete records according to workplace procedures
       

Submission Requirements

List each assessment task's title, type (eg project, observation/demonstration, essay, assignment, checklist) and due date here

Assessment task 1: [title]      Due date:

(add new lines for each of the assessment tasks)


Assessment Tasks

Copy and paste from the following data to produce each assessment task. Write these in plain English and spell out how, when and where the task is to be carried out, under what conditions, and what resources are needed. Include guidelines about how well the candidate has to perform a task for it to be judged satisfactory.

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 checksmust 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

Copy and paste from the following performance criteria to create an observation checklist for each task. When you have finished writing your assessment tool every one of these must have been addressed, preferably several times in a variety of contexts. To ensure this occurs download the assessment matrix for the unit; enter each assessment task as a column header and place check marks against each performance criteria that task addresses.

Observation Checklist

Tasks to be observed according to workplace/college/TAFE policy and procedures, relevant legislation and Codes of Practice Yes No Comments/feedback
Identify production requirements from workplace documentation 
Confirm materials meet production requirements 
Confirm required facilities, storage, equipment and personnel are available 
Select and fit personal protective equipment and contamination prevention clothing according to workplace procedures 
Clean, assemble and adjust equipment according to workplace procedures and operation and maintenance manual 
Set equipment components and related instrumentation to meet production requirements 
Conduct pre-start checks according to workplace procedures 
Complete equipment status reports according to workplace procedures 
Conduct pre-sampling tests and interpret test results to confirm column operation 
Identify and report out of limit test results according to workplace procedures 
Load product into columns according to specifications and production requirements 
Start up and monitor separation process to confirm process cycles occur in correct sequence according to specifications and production requirements 
Identify and report out of limit products or processes according to workplace procedures 
Confirm separation of solution meets specifications 
Conduct process according to safety and environmental requirements 
Complete documentation according to workplace requirements 
Confirm the workplace procedures for shutting down the process 
Safely shut down the process 
Complete records according to workplace procedures 

Forms

Assessment Cover Sheet

FBPPHM3007 - Operate a separation process using chromatography
Assessment task 1: [title]

Student name:

Student ID:

I declare that the assessment tasks submitted for this unit are my own work.

Student signature:

Result: Competent Not yet competent

Feedback to student

 

 

 

 

 

 

 

 

Assessor name:

Signature:

Date:


Assessment Record Sheet

FBPPHM3007 - Operate a separation process using chromatography

Student name:

Student ID:

Assessment task 1: [title] Result: Competent Not yet competent

(add lines for each task)

Feedback to student:

 

 

 

 

 

 

 

 

Overall assessment result: Competent Not yet competent

Assessor name:

Signature:

Date:

Student signature:

Date: