Cleaning Validation

Validating the cleaning of the equipment used to manufacture pharmaceuticals is a critical part of the process validation checklist that we can perform for you. This is also the case for equipment validation if you wish to ensure PIC/S or FDA compliance.

CiPharma offers a cleaning validation service, allowing you to outsource this time consuming task to experienced validation professionals.

You can have CiPharma representatives assist you with any of the following tasks:

  • Developing a cleaning validation plan and validation protocols for the equipment or reviewing existing documents
  • Collecting the validation samples, using your cleaning validation sampling tools
  • Analysing samples, using your procedure, e.g. conductivity measurements, TOC analysis, HPLC analysis or another analytical method.
  • Writing validation protocols and reports.

Fast Cleaning Validation Analysis

CiPharma’s Kaye Validator (Ion Trap Mobility Spectrometer (ITMS)) considerably reduces cleaning validation analysis times by providing on-line identification of contaminants in samples.

CiPharma’s Validation experts can use this powerful portable instrument to really accelerate a cleaning validation job, minimizing production downtime. Our trained specialists can develop a method for you, verify it, then collect and run the samples.

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.

The portability of the instrument means that samples can be run at the production line, removing the time needed to run samples to the lab.

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