Cleanroom Validation Service

Product Details:

Cleanroom Validation Process

• Density and integrity test of the HEPA filters

• Classification (up to 0,1 µm)
• Recovery times
• Measurement and adjustment of the air velocity
• Microbiological tests (surface and air)
• Measurements of temperature, humidity
• Measurements of light intensity
• Visualisation of airflow patterns
• Tests on your networks of compressed air (particles, microbiological, dew points)
• Laminar flow, biosafety cabinet, fume hood, isolator

Projects governed by regulatory compliance promote a structured approach to delivery, running through the project from design inception to handover. This life cycle validation from URS, VMP, DQ, IQ and OQ require an understanding of more than just the mechanical parts and build components. 

From high specification aseptic facilities, cleanrooms, specialist containment and other controlled facilities, we offer compliance to cGMP and cGLP standards to meet the stringent expectations of the associated regulatory bodies. With experience of delivering licensed facilities for the MHRA and FDA as well as other regulators including VMD and MDD, we offer a comprehensive service. 

Preliminary compliance assessments are all carried out in-house through simple 'flow mapping' whilst early consultation with the specific regulator forms an integral part of our on-going design development. With independent third parties employed for all physical testing, you can be assured of robust checking procedures.