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

FBPPHM3009 Mapping and Delivery Guide
Operate an aseptic form, fill and seal process

Version 1.0
Issue Date: May 2024


Qualification -
Unit of Competency FBPPHM3009 - Operate an aseptic form, fill and seal process
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 an aseptic form, fill and seal process within a graded cleanroom environment in a pharmaceutical manufacturing facility.The unit applies to individuals who use Good Manufacturing Practice (GMP) requirements and operation principles in the aseptic form, fill and seal 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: Set up form, fill and seal process
  • Identify production requirements from workplace documentation
  • Confirm materials, packaging components and consumables are available to meet batch and production requirements
  • Confirm required facilities and equipment are available
  • Source and fit cleanroom garments and personal protective equipment according to workplace gowning standard operating procedures (SOP)
  • Maintain contamination free gloves and gown according to workplace gowning SOP
  • Fit and adjust machine components and attachments according to production requirements and equipment operation and maintenance manual
  • Enter processing and operating parameters according to safety and production requirements
  • Check and adjust equipment performance according to equipment operating procedures
  • Conduct pre-start checks according to workplace procedures
       
Element: Operate and monitor a form, fill and seal process
  • Start up and monitor aseptic form, fill and seal process to confirm products are within required limits
  • Monitor packaging quality and seal integrity to confirm that specifications are met
  • Identify and report out of limit products or processes according to workplace procedures
  • Maintain work area according to workplace cleaning standards
  • Maintain consistent aseptic techniques
  • Conduct process and sampling according to safety requirements and environmental monitoring procedures
  • Contain, remove and report spillages according to SOP
  • Complete documentation according to workplace requirements
       
Element: Shut down a form, fill and seal process
  • Confirm the workplace procedures for shutting down the process
  • Complete end-of-batch procedures according to batch instructions
  • Safely shut down the process
  • Clean sealing equipment according to workplace procedures
  • De-gown according to workplace gowning SOP
  • 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.

Cleanroom garments and personal protective equipment must include:

coverall

disposable and/or reusable:

surgical or elastic gloves

face masks

hair nets and hoods

beard/moustache covers

goggles or glasses

overshoes or cleanroom boots and/or shoe covers.

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

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, packaging components and consumables are available to meet batch and production requirements 
Confirm required facilities and equipment are available 
Source and fit cleanroom garments and personal protective equipment according to workplace gowning standard operating procedures (SOP) 
Maintain contamination free gloves and gown according to workplace gowning SOP 
Fit and adjust machine components and attachments according to production requirements and equipment operation and maintenance manual 
Enter processing and operating parameters according to safety and production requirements 
Check and adjust equipment performance according to equipment operating procedures 
Conduct pre-start checks according to workplace procedures 
Start up and monitor aseptic form, fill and seal process to confirm products are within required limits 
Monitor packaging quality and seal integrity to confirm that specifications are met 
Identify and report out of limit products or processes according to workplace procedures 
Maintain work area according to workplace cleaning standards 
Maintain consistent aseptic techniques 
Conduct process and sampling according to safety requirements and environmental monitoring procedures 
Contain, remove and report spillages according to SOP 
Complete documentation according to workplace requirements 
Confirm the workplace procedures for shutting down the process 
Complete end-of-batch procedures according to batch instructions 
Safely shut down the process 
Clean sealing equipment according to workplace procedures 
De-gown according to workplace gowning SOP 
Complete records according to workplace procedures 

Forms

Assessment Cover Sheet

FBPPHM3009 - Operate an aseptic form, fill and seal process
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

FBPPHM3009 - Operate an aseptic form, fill and seal process

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: