Melbourn Increases Parenteral Testing Capacity
Melbourn Scientific Ltd is one of the first UK contract laboratories to invest 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.
Recent expansion into an ergonomically designed laboratory has enabled Melbourn to increase its capacity in specialist areas; as Business Development Director Mark Hammond explains: "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. 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."
The laser particle counter is designed to accurately sample liquids and is capable of measuring particulates in fluids with various refractive indexes, 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.
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.
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 programme, enabling an operator to collect, display, store and report in many different formats. The Pharmaceutical Net programme is very flexible for use as a simple monitoring tool or as an advanced analysis package.
About Melbourn Scientific
Melbourn Scientific Ltd provides contract analytical services for the pharmaceutical, biotechnology and healthcare industries.
An experienced team of analysts offers a wide range of services including method development, validation and transfer, stability studies and pharmacopoeial testing. The company also offers analysis of more complex delivery systems such as inhaled products and transdermal devices.
The laboratory is cGMP and GLP compliant. We have been on the GLP programme since 1992, and our approach to quality has meant that during four inspections by the FDA (against GMP as part of client PAI) in recent years we have never had a 483 or 'significant deficiency' noted.
Melbourn Scientific