Guardtech Group Validations
UPON conclusion of all cleanroom builds an ISO 14644 validation is conducted to verify cleanroom performance and adherence to classification guidelines.
The critical testing point is to ensure that the airborne particle counts are in line with the allowable tolerances as set out in ISO 14644-1. All other testing is to provide supporting data to confirm the performance specification of the environment.
Validation testing could include any or all of the following:
- Air velocity and volumetric flow rate measurement
- Room differential pressure testing
- Airborne particle counting
- Temperature & humidity monitoring
- Light & sound level measurement
- Filter integrity testing
- Pressure & flow gauge calibration
- Room recovery rates
- Containment testing
- Airflow visualisation
For all non-cGMP-rated projects, standard commissioning documentation will apply (see Commissioning).
A far greater level of detail is required for qualification of cGMP facilities, following strict protocols and defined standards.
This portfolio of documentation includes the compilation and execution of a Design Qualification (DQ), Installation Qualification (IQ) and Operational Qualification (OQ).
These documents are produced as a call and response to the User Requirement Specification (URS) and aim to objectively answer all requests with supporting evidence.
Guardtech Group Case Study Guardtech Group Validation Case Study
Discover the process undertaken by the Guardtech Service Department for a CleanCube Maxi Validation as part of an Operational Qualification (OQ).
GUARDTECH GROUP CASE STUDY ISO7 PACKAGING MODULAR
Discover the design innovation, processes and challenges that went into this ISO7 modular cleanroom for packaging precision engineering components.
GUARDTECH GROUP CASE STUDY ISO4, 6 & 7 NANOFABRICATION FACILITY
Discover the design innovation, processes and challenges behind this Nanofabrication facility at the University of Glasgow.
Guardtech Group Make an Enquiry
Got a question for the Cleanroom Solutions team? Maybe you have a rough idea of what you want and just need to flesh out the finer details? Click the button below to contact the team now for a rapid response to your enquiry.