Cleaning Validation

Validating the cleaning steps of your drug product manufacturing process is a critical component of avoiding an adulterated product. Adulteration can occur if there is any remaining product or cleaning agent in the manufacturing line prior to the start of the next batch. In order to prove your cleaning process is effective the validation of the process and subsequent monitoring are critical.

 

Avista Pharma routinely helps clients validate their cleaning processes by performing the following services:

  • Method development and validation of analytical assays (HPLC, TOC)
  • Performing swab recovery studies using the client’s swabbing instructions, drug product, and coupons of materials used in the manufacturing line
  • Performing routine testing of post-cleaning samples (HPLC, TOC)
  • Development of equipment specific cleaning validation protocols and reports
  • Development of protocols and sample testing to support qualifying technicians in swabbing

 

Avista Pharma utilizes Total Organic Carbon (TOC) methodology as well as High Performance Liquid Chromatography (HPLC) in cleaning validation assays. TOC is a great method for cleaning validations because it is a non-specific method that will measure organic compounds. It is useful in cleaning validations because it is able to detect numerous compounds at very low limits in a single measurement. A drawback of TOC is that, because it is a non-specific method, the source of the measured result is not known. It must be assumed that all of the TOC measured is from a single source. This understanding is very important when a cleaning validation is performed, as multiple limits may need to be applied against a single measured TOC result. If a component in the drug product is of particular concern and its presence or absence needs to be known,  a specific assay (such as HPLC) is recommended over the TOC assay. Avista Pharma has the equipment and knowledgeable scientists available to help develop these methods, validate these methods and apply these methods for assessing your cleaning results.