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Follow the links below to find material targeted to the unit's elements, performance criteria, required skills and knowledge

Elements and Performance Criteria

  1. Receipt materials and components
  2. Set up the production process for operation
  3. Dispense materials
  4. Operate and monitor the production process
  5. Hand over the production process
  6. Shut down the process

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.

Equipment must include:

at least one from the three items below:

bioreactor

tablet press

sterilising equipment

plus all of the following items:

filling machine

filtration equipment

mixing vessel

weighing instrument.

Cleaning requirements must include:

area or line clearance

full or partial clean

automated or semi-automated or manual cleaning of equipment

sanitation or sterilisation.

Equipment status must include:

calibrated

clean

clean/dirty hold time

in use

ready to use.

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

Items to monitor must include:

environment

product appearance

pH

volume or weight

temperature.