Validation and Calibration

Validation of HPLC, UV, FTIR and Dissolution equipment

With over 20 years’ experience validating analytical equipment in the pharmaceutical industry we can assist customers with the validation of their analytical equipment

It is very important to know if the instrument is still functioning correctly when performing analytical tests. Therefore validation of the equipment is very important.

Using only certified equipment and standards you will feel confident that the results are an accurate reflection of the instruments capabilities.

HPLC Validations

We can work from customer specifications or use general validation protocols like the V-Kit. V-kit is an analytical instrument qualification system for the OQ/PQ qualification of HPLC, GC, and tablet dissolution instruments and processes. The system includes different products for all types of laboratories.

Benefits (v-kit.com)

UV and Visible Spectrophotometry

UV and Visible Spectrophotometry is one of the most common tech­niques used in analytical science but it is essential to check instrument performance on a regular basis to ensure that it is within satisfactory parameters and corrective action must to be taken when found to be outside these limits.

We use Certified Starna® liquid-filled, heat sealed quartz cells which possess the good long-term stability and optical properties needed to evaluate performance of UV-Visible spectrophotometers.

Dissolution bath validations

We perform the mechanical validation according to the latest USP specification, using calibrated equipment.

We also perform the PVT test with prednisone tablets on most brands of Dissolution baths.

Why should you qualify and validate your analytical equipment?

The objective of any analytical measurement is to get consistent, reliable and accurate data. Proper functioning of the analytical instruments is very important to achieve this.

The second reason why validation and qualification are important, especially in an regulated and controlled environment is because it is a requirement of many guidelines.

THE USP now have a general chapter dealing with the qualification of analytical instruments.

The new USP chapter recommends the well-established qualification phases also for analytical instruments:

• Design Qualification

• Installation Qualification

• Operational Qualification

• Performance Qualification

One interesting fact is that, by performance qualification, the periodic checks of the instrument in defined intervals are meant, i.e. performance qualification now includes the regular calibration activities, preventive maintenance and necessary repairs over the whole runtime of the individual device - naturally taking change control into consideration.

What is especially helpful for daily practice is the USP's proposal of a stepped model for different categories of instruments. It suggests three categories:

• Group A (simple equipment)

• Group B (among others for thermometers, pH meters, refractometers)

• Group C (computer-based devices, like HPLC, GC, NIR, etc.)