Implementation
Our trained and certified engineers perform the system IQOQPQ following a specific sequence governed by controlled documentation for the building, testing and qualification of the mechanical, electronic and software components:
Once on site, engineers uncrate and assemble the robot which is followed by IQ and OQ testing of the performance of the readers and robotic system components. The PyroTec® PRO System configuration specific for the endotoxin automation application (kinetic LAL automation and/or rFC automation) commences with IQOQPQ of the on deck devices and labware. The robotic arm movements are fine-tuned to enable optimal alignment and performance. A standardized PQ assay protocol is conducted to test the full functionality of the system for each assay method for BET automation.
It is recommended that you prepare your own PQ protocol for endotoxin automation based on knowledge of the types of samples to be tested and the results obtained by the current manual BET method.
The PyroTec® PRO System is both simple to operate and to maintain. Users carry out a few simple procedures, through the WinKQCL® Software, at specified intervals to ensure efficient daily operation. The system can be protected by purchasing a Lonza maintenance contract that provides for both routine annual maintenance and emergency call out in the event of breakdown. Troubleshooting and support is accessed through our trusted Scientific Support Team.