Validation

At Cleanrooms Australia, we offer integrated cleanroom design and construction, therefore we take responsibility for delivering the facility that was promised to our client. This comes in the form of an At Rest Validation Report.  This report is provided by an unbiased third party on the performance of all our cleanrooms.

Cleanroom Validation

Depending on the cleanroom standard you are constructing your facility to, cleanroom validation may be as simple as proving the performance of your cleanroom in operational state.

Cleanroom validation can also refer to a VMP(validation master plan). A validation master plan is a document referred to by the GMP(which is the ‘Good Manufacturing Practice’ recommended by the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme – jointly referred to as PIC/S), and used in the pharmaceutical industry.

A cleanroom validation master plan is how your entire operation performs including:

  • personnel flow,
  • product flow,
  • material flow,
  • waste flow,
  • calibration,
  • maintenance,
  • training, etc.

There are three states to an operating cleanroom:

As built.
At rest.
In operation.

Third-party Cleanroom Validating Services

National Association of Testing Authorities, AustraliaWhen providing validation certification we always use NATA certified inspectors to provide NATA traceable reports.

NATA is the authority that provides independent assurance of technical competence through a proven network of best practice industry experts provided for customers who require confidence in the delivery of their products and services. NATA provides assessment, accreditation and training services to laboratories and technical facilities throughout Australia and internationally.