Cleanroom Validation

Whether you are manufacturing sterile medical devices, packaging pharmaceuticals or assembling electronic products, Ops Qual offer a comprehensive validation service for cleanrooms and associated controlled environments that will instil confidence in your customers and regulators.

Operating in accordance with the requirements of internationally recognised standards such as ISO 14644, and implementing GMP procedures we will customise your validation programme to meet your needs.  We can classify your environment and provide certification and reports to demonstrate that it complies with its air cleanliness classification requirements.

DOP Testing

Qualification Testing

Classification requires assessment of particulate concentrations, and this may be supplemented by the qualification of operational characteristics such as

  • airflow and /or air change rates
  • pressure differences between operational areas and the ambient environment
  • filter system integrity

Depending on your application, further testing in areas such as temperature, humidity, airflow visualisation, cleanroom recovery and biocontamination performance can all be added to your validation plan.