Cleaning Validation Services for Pharmaceutical Manufacturing

Cleaning validation of the equipment used to manufacture pharmaceuticals is a critical part of a process validation checklist, as is equipment validation if you wish to ensure FDA or TGA compliance.

PharmOut offers a cleaning validation service that allows you to outsource this task to experienced Validation consultants. The service can include any of the following components:

Developing a cleaning validation plan and validation protocols for the equipment or reviewing existing documents
Using the defined cleaning validation sampling tools to collect the validation samples
Analysing the samples, using the defined procedure, whether that be conductivity measurements, TOC analysis, HPLC analysis or another analytical method.
Writing up the validation protocols and reports.

Fast Cleaning Validation Analysis Using the Kaye Validator ITMS

PharmOut's Kaye Validator Ion Trap Mobility Spectrometer (ITMS)can speed up cleaning validation analysis by providing on-line identification of contaminants in samples.

Armed with this powerful portable instrument, a PharmOut Validation consultant can really accelerate a cleaning validation job, minimising production downtime.

The Kaye Validator offers pico-gram detection levels and rapid sample analysis time (approx. 10-30 seconds) and is a solvent-independent alternative to HPLC and Total Organic Carbon (TOC) analysis.

Being a compact at-line instrument, samples can be run at the production line, removing the time needed to run samples to the lab.

Our trained consultants can develop a method for you, verify it, then collect and run the samples.

With the reduction in production downtime and the low cost per analysis, the Kaye Validator service can quickly pay for itself.

To learn more about our Cleaning Validation services, please contact us.