Cleaning Validation

Cleaning Validation

IAL is a cGMP compliant facility available for developing, validating and performing analytical procedures used in equipment cleaning validation. Cleaning validation is a multi-step process that begins with focusing on the objective of the validation process. Typically, the objective is to prevent the adulteration or contamination of drug products that are manufactured on non-dedicated equipment. Cleaning studies demonstrate that chemical and microbiological residues that are detected are acceptable to predetermined criteria. 

Prior to developing the methods and conducting the validation, some important questions need to be asked. Questions such as do we utilize one cleaning process for all products or use different cleaning processes for different products. Perhaps a cleaning process for water soluble residues and another for non-water soluble residues will be utilized. IAL will work with you to determine the most efficient method(s) to clean your equipment so that you will meet all FDA requirements.  

Upon request, IAL will work closely with our clients to:

IAL's consultative approach has worked successfully on our past projects. Our scientists have developed and validated methods to quantitatively detect residues of various substances and contaminants from equipment surfaces. Templates for test methods and protocols are available so that customized protocols can be quickly developed for cleaning validation of non-dedicated manufacturing equipment.

Contact us to obtain excellence in service and quality data, and to allow us to become a valuable and trusted member of your team.