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Elements and Performance Criteria

  1. Plan and prepare to clean pharmaceutical processing areas and equipment
  2. Remove waste
  3. Clean and sanitise pharmaceutical processing surfaces
  4. Clean and sanitise pharmaceutical processing equipment
  5. Return plant to operating condition

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.

PPE must include:

one of the following:

protective gown

scrubs

smock

statcoat

cleanroom coverall

disposable coverall

plus all of the following:

disposable overshoes or cleanroom boots

hair net

goggles or safety glasses.

Waste must include:

cleaning material or product waste

hazardous waste

general processing and laboratory waste.

Monitoring of the cleaning process must include:

chemical strength

cycle time(s)

temperature

contact time

rinse water quality.

Sampling or testing methods must include:

visual inspection

pH tests of final rinse water

swabbing of equipment surfaces for presence of contamination.