Cleaning Validation

 Cleaning Validation (Medical Devices)

Cleaning Validation is the process of obtaining documented evidence that assures than an equipment-specific cleaning process will consistently yield results meeting specifications and quality standards. This type of validation is performed by the medical device and pharmaceutical industries to prevent the risk of contamination. ADB Consulting has a set of tools to determine that a particular equipment cleaning procedure is capable of removing residues to predetermined levels of acceptability.
Our broadest set of cleaning validation procedures helps the medical device industries make sure that all the residues, contamination and cross-contamination risks are removed. ADB’s effective strategies involving a complete cleaning validation lifecycle program ensures continued compliance to meet FDA regulations.
ADB can assist Medical device and Pharmaceutical industries in any of the following tasks:
Implement a cleaning procedure to help you gain FDA approval
Select residue and contamination detection method, and identify the risk drivers.
Select a reliable sampling method and determine why you are exceeding your residue limits
Verify that process changes have not affected manufacturing cleanliness
Writing procedures and documentation citing the end results
Continually monitoring the cleanliness of your manufacturing processes
 
 

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