Pharmaceutical Cleaning: Insoluble Enteric Tablet Coating

Q. Water insoluble tablet coatings used for solid dose enteric pharmaceutical tablets are very difficult to clean from coating equipment and tablet presses. It was hard to validate the equipment and prevent cross contamination.  Can Alconox Inc. assist?

A. Enteric coatings are designed to survive the acidity of the stomach.  Hence acidic detergents, generally, would be less effective than alkaline types.  These alkaline types would be detergents such as hot (140F/60C or higher) Detonox® Ultimate Precision Cleaner and Solujet® Low-Foaming Phosphate-Free Liquid for high and low foaming applications, respectively.

However, not all insoluble tablet coatings are created equal.  Residues of enteric coating can build up.  There may be the need for the use of hot 140F/60C Citranox® Liquid Acid Cleaner and Detergent at a 2% concentration.  This allows for the successful removal of water insoluble salts used in these coatings.  This would be the recommendation for manual methods including scrubbing, soaking and sonication. Instead, if the tablet press parts are being cleaning in a washer, high pressure sprayer or has its own clean-in-place system, we would go with a low foaming equivalent detergent, specifically: Citrajet® Low-Foam Liquid Acid Cleaner/Rinse.

In all cases, initial rinsing should be at or near wash temperatures to avoid breaking emulsions that may have formed.  Subsequent rinses can be at ambient.

The following whitepapers will provide assistance with pharmaceutical, biopharma and related cleaning validation efforts:

• The Applications in Pharmaceutical Manufacturing White Paper
• The Cleaning Validation for Pharmaceutical Manufacturing White Paper
• Cleaning and Monitoring Procedures
• Cleaning Validation References

We are happy to discuss your individual pharmaceutical cleaning needs at any time.

To request any Alconox Inc. detergents for free, please complete the questionnaire at Get Sample. For more information about any one of our Alconox Inc. detergents, consult the technical bulletin for each product. Or click here to access each of our detergent’s Safety Data Sheets.

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