Technical Tip

Comparison of Pharmaceutical Detergents for Effective OSD Soil Cleaning

STERIS conducted a study to determine the effectiveness of ProKlenz ALIGN Detergent when cleaning common soils found in pharmaceutical OSD manufacturing. This article will review the results of the study and the benefits of ProKlenz ALIGN Detergent compared to other detergents.
November 30, 2022

Key Takeaways:

  • ProKlenz™ ALIGN Detergent effectively cleaned all 13 oral solid dose (OSD) soils tested—including challenging residues like METHOCEL™, simethicone and zinc oxide—using both agitated immersion and manual cleaning methods.
  • The detergent met all three acceptance criteria (visual inspection, water-break-free and gravimetric residue <0.1 mg) under various time and temperature conditions.
  • Compared to competitor neutral and alkaline detergents, ProKlenz ALIGN achieved superior cleaning results in less time, particularly for difficult soils.
  • The detergent is compatible with a wide range of substrates, requires no neutralization before drain discharge and is safe for both CIP and manual cleaning applications.
  • STERIS provides extensive technical support and documentation, including validation data, analytical methods and on-site consultation, to support cleaning process development and regulatory compliance. 

Pharmaceutical oral solid dose (OSD) manufacturers encounter many unique challenges throughout the manufacturing process, including substrate compatibility limitations and cleaning challenging soils like binding and coating agents that are used to manufacture pills, tablets and capsules.

ProKlenz™ ALIGN Neutral Pharmaceutical Detergent from STERIS was developed for pharmaceutical OSD manufacturers to harmonize cleaning protocols. It features a balanced pH profile and offers effective but gentle cleaning for a wide range of process residues found in clean-in-place (CIP) and manual applications. STERIS conducted a study to determine the effectiveness of ProKlenz ALIGN Detergent when cleaning common soils found in pharmaceutical OSD manufacturing. This article will review the results of the study and the benefits of ProKlenz ALIGN Detergent compared to other detergents.

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