We have a trained and qualified team to perform maintenance on high-containment isolators. Among the services performed during maintenance, we highlight:
Leakage test (sealing):
The leakage/sealing test on the isolators is performed according to a procedure based on ISO 10648-2 and ISO 14644-7 standards. This aims to verify/check the system’s sealing through differential pressure.
Chamber classification verification:
The chamber classification verification aims to check if the equipment is meeting the containment levels according to its nominal specifications.
Ventilation test (sleeve breakage):
The ventilation test is performed to assess if the equipment is responding adequately in the event of containment breakage.
Pressure cascade calibration:
Calibration of solenoid valves responsible for pressure cascade control.
Oxygen sensor calibration:
Perform calibration procedure for the zero point and reference point of the oxygen sensors.
Visual verification of external wear or damage:
Prepare a photographic report with points of wear or damage found during periodic visits, indicating probable deviations and necessary actions.
General adjustments as per inspection:
Perform general adjustments to equipment as identified in periodic inspections (nitrogen flow rate in inerting, application of protective coating to the stainless steel structure, etc.).
Filter replacements:
Verify the need for and replace filters that do not have a Bag-In/Bag-Out system.
Performance qualification (SMEPAC):
“Standardized Measurement of Equipment Particulate Airborne Concentration”, consists of verifying the actual performance of isolators in relation to particle containment.