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Evidence Guide: FBPPHM3008 - Operate an aseptic fill and seal process

Student: __________________________________________________

Signature: _________________________________________________

Tips for gathering evidence to demonstrate your skills

The important thing to remember when gathering evidence is that the more evidence the better - that is, the more evidence you gather to demonstrate your skills, the more confident an assessor can be that you have learned the skills not just at one point in time, but are continuing to apply and develop those skills (as opposed to just learning for the test!). Furthermore, one piece of evidence that you collect will not usualy demonstrate all the required criteria for a unit of competency, whereas multiple overlapping pieces of evidence will usually do the trick!

From the Wiki University

 

FBPPHM3008 - Operate an aseptic fill and seal process

What evidence can you provide to prove your understanding of each of the following citeria?

Set up filling and sealing process

  1. Identify production requirements from workplace documentation
  2. Confirm materials, packaging components and consumables are available to meet batch and production requirements
  3. Confirm required facilities and equipment are available
  4. Source and fit cleanroom garments and personal protective equipment according to workplace gowning standard operating procedures (SOP)
  5. Maintain sterile quality of the gown according to workplace gowning SOP
  6. Fit and adjust machine components and attachments according to production requirements and equipment operation and maintenance manual
  7. Enter processing and operating parameters according to safety and production requirements
  8. Check and adjust equipment performance according to equipment operating procedures
  9. Conduct pre-start checks according to workplace procedures
Identify production requirements from workplace documentation

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Confirm materials, packaging components and consumables are available to meet batch and production requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Confirm required facilities and equipment are available

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Source and fit cleanroom garments and personal protective equipment according to workplace gowning standard operating procedures (SOP)

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Maintain sterile quality of the gown according to workplace gowning SOP

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Fit and adjust machine components and attachments according to production requirements and equipment operation and maintenance manual

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Enter processing and operating parameters according to safety and production requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Check and adjust equipment performance according to equipment operating procedures

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Conduct pre-start checks according to workplace procedures

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Operate and monitor a filling and sealing process

  1. Start up and monitor aseptic fill and seal process to confirm products are within required limits
  2. Monitor packaging quality and seal integrity to confirm that specifications are met
  3. Identify and report out of limit products or processes according to workplace procedures
  4. Maintain work area according to workplace cleaning standards
  5. Maintain consistent aseptic techniques
  6. Conduct process and sampling according to safety requirements and environmental monitoring procedures
  7. Contain, remove and report spillages according to procedures
  8. Complete documentation according to workplace requirements
Start up and monitor aseptic fill and seal process to confirm products are within required limits

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Monitor packaging quality and seal integrity to confirm that specifications are met

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Identify and report out of limit products or processes according to workplace procedures

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Maintain work area according to workplace cleaning standards

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Maintain consistent aseptic techniques

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Conduct process and sampling according to safety requirements and environmental monitoring procedures

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Contain, remove and report spillages according to procedures

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Complete documentation according to workplace requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Shut down filling and sealing process

  1. Confirm the workplace procedures for shutting down the process
  2. Complete end-of-batch procedures according to batch instructions
  3. Safely shut down the process
  4. Clean sealing equipment according to workplace procedures
  5. De-gown according to workplace gowning SOP
  6. Complete records according to workplace procedures
Confirm the workplace procedures for shutting down the process

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Complete end-of-batch procedures according to batch instructions

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Safely shut down the process

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Clean sealing equipment according to workplace procedures

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

De-gown according to workplace gowning SOP

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Complete records according to workplace procedures

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Assessed

Teacher: ___________________________________ Date: _________

Signature: ________________________________________________

Comments:

 

 

 

 

 

 

 

 

Instructions to Assessors

Required Skills and Knowledge
Range Statement

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.