Validation & Servicing
BS EN ISO 14644, covering clean air environments, states that the performance of all clean air devices should be monitored on a regular six or twelve monthly basis.
Validation & Servicing
The performance of the equipment, or facility, is critical to the protection of the product and, in certain applications, the operator. It is, therefore, vital that the equipment is maintained in a fully functional and serviceable condition by qualified engineers.
The services provided by Amercare will only be performed by an Amercare trained Service Engineer. The service includes the main recommended tests, as follows: Airborne particle counts, Air velocity readings and filter integrity testing, carried out using test and recording equipment calibrated in accordance with the manufacturers recommendations.
All results will be summarised in a report and issued, together with copies of the appropriate Certificates of Calibration for the test equipment used.
Service details:
- Test electrical safety features.
- Check the condition and operation of the isolator and replace consumable parts.
- Calibrate Pressure & Flow measurement transducers.
- Leak Test all sections of the isolator.
- Particle Counting all isolator sections including Clean Up tests for transfer chambers (1m3 samples from each section).
- Measure and record Breach Velocities through Glove Ports (negative pressure Isolators only).
- Aerosol Challenge Testing of Inlet Filters.
- Testing and Calibration of any additional fitted equipment such as Centrifuge.
Tests carried out will comply with the applicable standards:
ISO 14644: Cleanroom & associated controlled environments | Part 1: 1999 Classification of air cleanliness. | Part 2: 2000 Specifications for testing and monitoring to prove continued compliance with ISO 14644-1. | Part 3: 2005 Test Methods. | Part 7: 2004 Separative devices. | ISBN 0 85369 573 3: Pharmaceutical Isolators (A guide to their application, design & control).
CONTACT OUR VALIDATION & SERVICING TEAM TO ARRANGE A VISIT