Cleaning Process Development

CPCI™ is the pioneer in the area of Cleaning Process Development having devoted many years of research into developing new methods and new patented technologies (USPTO No. 10,955,396) that have resulted in new and truly Science, Risk and Statistics-based approaches to Cleaning Process Development. These techniques are particularly important in Risk Reduction efforts when the Risk Analysis or Risk Evaluation shows that the Risk to patient safety is too high.

    Need help with Cleaning Process Development?

    CPCI™ can provide rapid and cost effective laboratory services following ASTM Standards E3106, G121 and G122 and high quality statistical reports using our patented technologies to guide you in the development of cleaning processes.

    Contact      CPCI™ today!

Bench Scale Cleaning Process Development

USPTO No. 10,955,396


Cleaning Process Development Reports

"Cleanability Testing"/Cleaning Effectiveness Factor (CEF) using 2 sample t-Tests
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"Cleanability Testing" ANOVA with Multiple Comparisons (Tukey, Fisher, Dunnett, Hsu's and Games Howell)
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Cleaning Agent Comparisons using ANOVA
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 Cleaning Agent Comparisons ANOVA with Multiple Comparisons (Tukey, Fisher, Dunnett, Hsu's and Games Howell)
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"Time-to-Clean" studies using Non-Linear Regression Analysis
Additional Evaluations include:

"Dirty Hold Time" evaluation using ANOVA and multiple comparisons (Tukey, Fisher, Dunnett, Hsu's  and Games-Howell)

Critical Process Parameter evaluations using Design of Experiments (Full Factorial Designs)
CPCI™ has developed laboratory instruments for evaluating compounds/products, following the ASTM G121 Standard Practice and the ASTM G122 Standard Method, to compare their ability to be cleaned to other compounds/products so as to create a ranking system for determining "hardest-to-clean" compounds/products using a standard procedure or a customized procedure for your cleaning process. These same procedures can be used to screen Cleaning Agents to determine the best Cleaning Agent for your compound/product or to compare Cleaning Agents to show equivalency for Cleaning Validation "bridging" studies. Equivalency studies can be used to justify reducing or even eliminating Cleaning Validations (3X runs) for New Products.
  1. "Hardest-To-Clean" Product Determination 
  2. Cleaning Agent Selection
  3. "Time-To-Clean" Studies
  4. Dirty Hold Time Studies
  5. Cleaning Agent Screenings or Comparisons for "bridging studies"
  6. New Product Introductions
  7. Design of Experiment (DoE) for Cleaning Process Design Space and Optimization for:
    • Manual Cleaning Process
    • COP Cleaning Process
    • CIP Cleaning Process

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CPCI™ provides high quality reports to its customers with detailed statistical analysis following ASTM E3106 recommendations. Tired of seeing simplistic 1 or 2 page reports from cleaning agent vendors that always recommend one of their cleaning agents? CPCI™ always compares cleaning agents to WATER as recommended by ASTM E3106. Research at CPCI™ has shown that many pharmaceutical products can be cleaned with water alone at the right temperature. CPCI™ does not collaborate with cleaning agent vendors so provides independent 3rd party evaluations you can trust and we will always recommend the most appropriate cleaning agents (only if they are needed)