Benefits of Pharmaceutical Detergents with Proteinaceous Soils
This technical tip takes a closer look at selecting cleaning detergents.
March 22, 2021
Key Takeaways:
- Pharmaceutical detergents like CIP 100™ and ProKlenz™ ONE use multiple synergistic cleaning mechanisms—including dissolution, solvation, chelation and surfactancy—to outperform commodity chemicals like sodium hydroxide in removing proteinaceous soils.
- In experimental comparisons, both CIP 100™ and ProKlenz™ ONE achieved visual cleanliness and met USP limits for TOC (≤500 ppb) and conductivity (≤2.5 µS/cm), while 0.1 N and 0.5 N NaOH failed visual inspection and were not further analyzed.
- Pharmaceutical detergents required approximately 22% less rinse water and achieved validated cleanliness in 40% less time than sodium hydroxide, demonstrating significant water and time savings.
- The Sinner’s Circle (TACT: Time, Action, Chemistry, Temperature) framework illustrates how optimized cleaning agents can reduce the need for high temperatures, long cycles or high chemical concentrations.
- STERIS detergents are globally available, validation ready and supported by technical expertise, including the PACE™ program, which helps Customers develop effective, sustainable and compliant cleaning protocols.
The ability to clean proteinaceous soils is a critical aspect of maintaining pharmaceutical equipment to ensure product quality and safety. Between 2006-2019, the FDA generated more than 3,078 Form 483 citations related to the FDA’s Code 21 CFR 211.67 and 21 CFR.182 for equipment cleaning, maintenance, and use log. To avoid FDA-related citations and ensure product quality and safety, it is important to use an effective, validatable cleaning agent in equipment cleaning and maintenance. This white paper takes a closer look at selecting cleaning detergents.
This technical tip takes a closer look at selecting cleaning detergents.
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