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VALIDATION AND SERVICING

Validation and Servicing

The operation of our isolators is crucial to safeguarding the product and the operator. It is essential to ensure that the equipment is kept in optimal working condition by our engineers.

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​We have a dedicated service team who cover UK, Ireland and Europe who offer a rapid response time from our intial remote testing for urgent response, through to regular preventative servicing and maintenance.​

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All results will be compiled into a detailed report, accompanied by copies of the relevant Certificates of Calibration for the testing equipment used.

APPLICABLE STANDARDS

​All testing is carried out to the applicable standards below:

  • ISO 14644 series: Cleanrooms and associated controlled environments

  • ISO 14644 Annex 1

  • Pharmaceutical Isolators Yellow Guide 0 85369 573 3: A guide to their application, design & control.

Validation and Servicing

TESTING

Servicing and validation will only be carried out by a Cirrus-trained Service Engineer. The service includes key tests:

  • Airborne particle counts

  • Air velocity measurements

  • Pressure readings and pressure cascade checks

  • Smoke visualisation

  • Leak testing

  • DOP filter integrity testing

All performed using calibrated test and measuring equipment in accordance with the manufacturer’s guidelines.

SMOKE VISUALISATION

We provide full smoke visualisation to assess airflow direction, uniformity, and behaviour ensuring proper equipment functionality and compliance with design specifications in accordance with ISO 14644 Annex 1.
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