Validation

For all servicing requirements please telephone +44 (0) 1489 885111

The performance of your equipment or facility is critical to the protection of the product, and in certain applications the end user. It is therefore vital your equipment is maintained in a fully functional and serviceable condition.

Our in-house capability can offer to validate:

  • Cleanrooms
  • Softwall cleanrooms and mobile enclosures
  • Containment suites
  • Laminar flow cabinets
  • Biological safety cabinets
  • Isolators

All of the above will be validated to the appropriate standards.

Using equipment with calibration trace ability Bassaire can perform:

  • HEPA Filter installation leak tests to PD6609
  • Airborne particle counts to ISO 14644 / BS5295 / cGMP / Fed 209e
  • Room pressure measurements
  • Airflow balances
  • Recovery performance
  • Noise and lighting levels
  • Air flow visualisation
  • Air flow and airchange rates
  • KI containment testing to EN12469
  • Laminarity measurements

All results will be issued together with a professionally written report.

Bassaire can also provide the following protocols to obtain MCA /FDA approvals.

  • Design Qualification Protocol
  • Installation Qualification Protocol
  • Operation Qualification Protocol