Cleaning Validation

Cleaning Validation Master Planning

Validating the cleaning 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 regulatory compliance.

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

You can have PharmOut staff 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 (yes, they LOVE dangling by their ankles into your mixing vessel! We even have extra-thin people to fit in tight places.)
  • Analysing samples, using your procedure, e.g. conductivity measurements, TOC analysis, HPLC analysis or another analytical method.

Cleaning Validation

Cleaning validation is a documented and well structured program to ensure that a cleaning process removes impurities (usually the API or its degradation by-products) from a product manufactured in a piece of equipment, the cleaning chemicals in the cleaning process. All residues must are removed to predetermined levels to ensure the quality of the next product manufactured is not compromised by waste from the previous product and the quality of future products using the equipment, to prevent cross-contamination.

The FDA for example defines Cleaning Validation in the context of API manufacture as: “The process of providing documented evidence that the cleaning methods employed within a facility consistently controls potential carryover of product (including intermediates and impurities), cleaning agents and extraneous material into subsequent product to a level which is below predetermined levels”.

Fast Cleaning Validation Analysis

PharmOut’s, Ion Trap Mobility Spectrometer (ITMS) considerably reduces cleaning validation analysis times by providing in-line identification of contaminants in samples.itms used in cleaning validation

A PharmOut Validation contractor can use this powerful portable instrument to really accelerate a cleaning validation job, minimising production downtime. Our trained contractors can develop a method for you, verify it, then collect and run the samples.

The ITMS 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 ITMS service can quickly pay for itself.

More information

If you would like a quote or to ask questions, please contact us.