ORAL SOLID DOSE – Equipment Cleaning

Hello good people of the world! Continuing the series on oral solid dosage forms, today we’re going to talk about equipment cleaning. OSD manufacturing equipment can be notoriously hard to clean, and manual cleaning procedures introduce high risk of contamination and carryover. It is recommended that any new or existing process equipment be cleaned with automated processes wherever possible.

The three automated cleaning processes typically used in industry are:

  • Clean-in-Place (CIP)
  • Wash-in-Place (WIP)
  • Clean-out-of-Place (COP)

CIP is done without moving the equipment, as the name implies, and uses a CIP skid to deliver cleaning and rinse solutions. CIP should not require any manual operations.

WIP is done in-place as well, but may include some manual operations, such as removing filters.

COP requires equipment to be moved to a wash station. Tanks and vessels are typically COP’d.

Some specific concerns related to cleaning OSD equipment include:

  • Dry Granulator/Roller Compactor cannot typically be CIP’d. Particularly the auger must be removed and COP’d.
  • Fluid Bed Dryers a large and complex, making cleaning difficult. Modern dryers will include CIP/WIP but typically still require manual cleaning of some parts.
  • Milling equipment typically requires the screen to be manually removed before any CIP/WIP.
  • Tablet presses can be difficult to clean, requiring many manual interventions prior to washing.
  • Capsule filling machines should be wettable to allow cleaning.
  • Tablet coaters should include WIP

Of course, cleaning processes, whether automated or not, need to be validated. Riboflavin tests may be performed to verify wash coverage, and swabbing can verify lack of residual API and cleaning solutions.

What challenges have you run into in cleaning your OSD manufacturing equipment? Comment below!

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