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Validation

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.

What Clients Say

From first meetings through to the final meeting Bassaires’ team have provided a clear, concise and detailed approach to all aspects of the project they have undertaken, responding timely and efficiently to all queries.

Jamie Douglas | Estates Projects Manager | Sheffield Children’s NHS Trust

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 namely ISO14644, cGMP,

EN 12469,  EN14175 and ACDP 1234

Using equipment with calibration trace ability Bassaire can perform:

  • HEPA Filter installation leak tests

  • Airborne particle counts

  • Room pressure measurements

  • Airflow balances

  • Recovery performance

  • Noise and lighting levels

  • Temperature mapping

  • Air flow visualisation

  • Air flow and airchange rates

  • KI containment testing

  • 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

Established in 1954, Bassaire is the oldest cleanroom company in the UK, and has been awarded ISO9001:2015 accreditation.

Experts in:

Some of our clients:

ipsen
hospira
Harwell
space
Colgate-Emblem
Baxter-2
Merial
AstraZeneca
siemens
MOD
NHS
Unilever-logo-1536x922
merck-logo-panel-1536x1026
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