Cleaning Process Development

CPCI™ is a pioneer in the area of Cleaning Process Development having devoted many years of research into developing new methods and new technologies (patents pending) that have resulted in rapid and cost-effective new approaches that are truly Science, Risk and Statistics-based. 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.

Bench Scale Cleaning Process Development
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

See our articles on:

Determining "Hardest to Clean" Products
Cleaning Agent Selection
"Time to Clean" Studies and the "Cleaning Assurance Level"
Using Design of Experiments in Cleaning Validation

Full Scale Cleaning Process Development
After the Bench Scale studies have selected the appropriate Cleaning Agent and narrowed down the parameters, a strategy for executing Full Scale Studies can be implemented quickly and easily with a much greater chance of 1st time success along with a much lower chance for any cleaning failures.