Melbourn increases parenteral testing capacity

UK contract laboratory Melbourn Scientific has invested in a light obscuration particle counter, enabling it both to size sub-visible particles and to count them accurately in liquid samples.

This development combined with light microscopy techniques and newly expanded and refurbished stability storage suite, further extends the company's capacity in stability testing of injectable solutions.

The LiQuilaz laser particle counter from Particle Measuring Systems is designed to sample liquids accurately and is capable of measuring particulates in fluids with various refractive indices, viscosities and operating temperatures. Applications include quality control for consistency of particles and uniform suspension, the real time detection of contamination at user selected sizing sensitivities, which can be up to 15 different channels. The sensitivity thresholds can be adjusted to aid characterisation of particle size and concentration.

The investment in the LiQuilaz equipment improves the accuracy and speed of analysis, enabling Melbourn to increase its throughput and efficiency. The precision of the counter means that short sampling intervals can be used without sacrificing statistical significance.

The sampled data is processed using a powerful software program, enabling an operator to collect, display, store and report in many different formats. The Pharmaceutical Net program is very flexible for use as a simple monitoring tool or as an advanced analysis package.

Recent expansion into an ergonomically designed laboratory has enabled Melbourn to increase its capacity in specialist areas. 'We have seen significant growth in demand for the analysis of parenterals and have increased capacity in this area by investing in additional facilities, equipment and people since we moved into the laboratory in August, and further expansion is planned,' said business development director Mark Hammond.

'Within the new facility we have the opportunity to create dedicated areas for the different procedures, giving clients access to specialist equipment as and when it is required.'

Particle counting at Melbourn is carried out using a variety of techniques that are compliant with USP and PhEur pharmacopoeia for parenteral/injectable solutions, patches and bags. In addition to the sub-visible particle counting using a light obscuration particle counter the company also uses light microscopy, for the visual assessment of particulates and precipitates, which gives the option for photographic recording of the findings.