Validation And Calibration

Much like our philosophy for designing quality instrumentation, Distek's Pharmaceutical Validation Services Group utilizes highly skilled chemists and technicians dedicated to meeting your needs for dissolution validation. The Distek Pharmaceutical Validation Services Group offers products and services in the areas of Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Preventative Maintenance (PM) on a one-time or annual contract basis.

Installation Qualification (IQ)
Assures your instrument is received in good condition and as ordered. We will confirm the system meets product specifications. The system will be inspected to verify it is in good working condition, all proper connections and accessory installation will be checked.

Operational Qualification (OQ)
Verifies the system is functioning and that all critical operational parameters are within stated specification. The key parameters checked and verified for a dissolution system are; level, height, centering, wobble, RPM, vibration and temperature.

Performance Qualification (PQ)
The purpose of the PQ is to certify, with documented evidence, the performance of a Dissolution system as per the system suitability test requirements of USP Chapter <711> using USP calibrator tablets.

Preventative Maintenance (PM)
Is performed to assure that the system continues to operate properly and that no component becomes incompatible due to use. All electronic and mechanical components will be inspected and replaced as necessary.