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A2 Pharmacy Isolator - Validation and QC Testing

Both transfer chambers and the process Isolator are fitted with test points for monitoring and validation. These are located in the front panel of the isolator. Test points are also provided for filter validation and at key stages throughout the Isolator System.

Isolator integrity is demonstrated by means of a pressure hold test which is simple to carry out. The pressure hold test is carried out at 1000Pa for a negative pressure isolator and 250Pa for a positive pressure isolator. The test takes 10 minutes and is timed and monitored by the control system. Leak test bungs are placed over the air inlets and the air extracts to each isolator chamber. Placing the bungs in the correct order establishes the leak test pressure conditions and seals the isolator for the test. Once the test conditions are established the operator is asked to press a button on the control system to start the test.

If the change in pressure is within preset limits of the performance established during commissioning and validation of the isolator then the integrity of the isolator has been maintained. The control system will indicate a pass and the isolator returned to normal operating conditions by removal of the leak test bungs.