Verification of Mastersizers

What is Verification?

Verification is a process similar to Calibration except that, since laser diffraction instruments are based on first principles of physics, there is no "tuning" process as there is with instruments requiring calibration.

However, it is clear that, even if these instruments do not need to be regularly tuned, their performance must be checked periodically. This process of checking is known as Verification.
The verification process involves challenging the instrument by measuring a known standard or standards. In the event that the measurement results fall outside established limits, the integrity of the set-up of the instrument is restored.

Verification versus Operational Qualification.

An Operational Qualification (OQ) is a similar operation to a verification which is typically performed by (and for) users in the pharmaceutical industry. Although the basic testing operation is the same, the procedural overhead associated with the performance of an OQ is much greater and more documentation must be provided.

Materials used

• For the optical bench :Polystyrene latices
• For the sample dispersion units: Quality Audit Standards.
• For Mastersizer X and Mastersizer S systems, latex is currently preferred but a reference reticle may be used for verification of dedicated spray measurement systems where there is no sample dispersion unit available to perform a latex measurement.

Routine Verification.

This is ideally carried out using Malvern Quality Audit Standards on a regular basis, the frequency of which depends on the quantity and value of the product being characterized by the particle size analyzer. It is self-evident that it would be commercially unwise to restrict verification to an annual process since a failure of such a verification would necessitate the possible recall of a year's production! A combination of quality Audit Standards and latices can be used to troubleshoot a system.

Relocation of Instruments and Verification.

Companies subject to regulation by the FDA and other Regulatory Authorities, should verify their instruments before and after relocating an instrument in order to be able to demonstrate that no adverse effect has resulted from the move. This requirement is applicable to most analytical instruments which rely on the integrity of set up and alignment of an optical system.