Melbourn Scientific expands parenteral testing capacity
counter to size and count particles in liquid samples using light
microscopy, to expand the company's capacity in stability testing
and to increase throughput and efficiency.
The UK-based contract analytical service provider has extended its range of stability testing equipment to include a laser particle counter (LiQuilaz from Particle Measuring Systems) used in conjunction with light microscopy. The technology is designed to measure and count sub-visible particles in liquid samples under different refractive indexes, viscosities and operating temperatures.
The main area of application is in quality control, where the counter is used to check for particle consistency, uniform suspension and real-time contamination detection at 15 different size ranges improving accuracy and speed of analysis. The investment of a particle counter enables Melbourne Scientific to meet an increasing demand for this type of technology.
"The traditional way of measuring particles is visually - which is time consuming and subject to human error. Melbourn is conducting trials to compare the techniques - the results for the new equipment are showing good reproducibility," Rachel Holdsworth, Melbourn Scientific spokesperson told In-PharmaTechnologist.com.
"Particles need to be below a certain size for injectables - so it is an important test."
"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 Mark Hammond, Melbourn Scientific business development director.
The number of drugs delivered by parenteral routes is on the increase, shadowing the rising number of large-molecule biologics on the market that require administration by injection.
"Within the new facility we have the opportunity to create dedicated areas for different procedures, giving clients access to specialist equipment as and when it is required," added Hammond.
Melbourn Scientific particle counting techniques are compliant with United States Pharmacopeia (USP) and European Pharmacopoeia (PhEur) for parenteral/injectable solutions, bags and patches. The company uses a software programme - the pharmaceutical net - to process sample data. This allows for an operator to display, report, collect and store data in several different formats.
Melbourn has clients worldwide - Europe, Australia, USA - and employs 35 people.