FAQ - Pharmaceutical/Life Sciences Particle Counting

APSS 200 System with IQ OQ Documentation

Question
How does the IQ/OQ validation differ from calibration?

Answer

Calibration

The calibration of the particle counter verifies that the optical component (particle counter) of the system meets the required standards for particle counting, i.e. sizing, resolution etc. It also ensures that the laser is functioning correctly and any adjustments required to bring it to standard are made. The sizing aspect of the calibration are performed using NIST traceable latex spheres for the sizes 2, 5, 10, 15, 20, 25, and 30 um giving us full extrapolative abilities for any size above the smallest size threshold, as this accurately maps out the calibration curve.

IQ/OQ Validation

Validation is the process where we take the calibrated particle counter and integrate it into a system (for example, the APSS 200 System System which includes the particle counter, Syringe Sampler, SamplerSight Software, computer, and reporting abilities. The additional tests are run to verify it compliance with the Pre 04.2007 USP test <788> (the APSS 200 exceeds the requirements of the current USP 788 as many of the validation components have now been dropped). Those tests include:

• System IQ
• Software installation
• Zero counting
• Flow rate
• Volumetric accuracy
• Counting accuracy using 15 um particles (3600/mL)