NEWS
Melbourn launches new aerosol characterisation service
Inhalation of spray particles is one of the health risks that aerosol manufacturers have to address following the update to the Aerosol Dispensers Directive 75/324/EEC, which comes into force in April 2010. To help companies meet this new requirement, Melbourn Scientific, with its knowledge of inhaled product development for pharmaceuticals, is introducing a suite of aerosol characterisation services to support the general aerosol industry.
From April 29th, manufacturers of personal and domestic aerosol dispensers are required to perform a hazard analysis to demonstrate they understand the health implications of their products. This hazard analysis includes assessment – where appropriate – of the risk of spray droplet inhalation and this requires knowledge of the aerosol droplet size distribution, along with the physical and toxicological properties of the formulation.
Mark Hammond, CEO of Melbourn Scientific, explains that the techniques used to assess the risks of inhalation are well understood for pharmaceutical aerosols.
“Much of our work in the healthcare arena is aimed at ensuring that particles or droplets are the right size for delivery to a specific area of the respiratory tract. For example we routinely measure nasal sprays to show that the product is targeted to deliver to the nasal cavity and the risk of inhalation is minimal. Conversely we routinely perform formulation and testing services for clients who wish to deliver products directly to the lungs.
“This invaluable knowledge gained in a highly regulated area enables us to work with new clients to ensure that tests are best suited to their products.”
Melbourn Scientific is collaborating with Malvern Instruments and Copley Scientific on a series of studies aimed at refining the techniques and technologies currently available to meet the needs of aerosol manufacturers.
Mark continues, “Melbourn has developed significant expertise in the field of pharmaceutical aerosol characterisation and we are now seeing increased interest from healthcare, personal care, household and other aerosol manufacturers for similar data, in order to aid with understanding and minimising the risk of accidental droplet inhalation.”
Paul Kippax, Product Manager for Malvern Spraytec aerosol particle sizing system, comments, “Aerosol manufacturers will need to be aware of the requirements for aerosol particle size characterisation, both to understand the product function, and also to assess the risks associated with fine particle exposure.
“Much of the experience gained in characterising pharmaceutical products, such as nasal sprays, is easily transferable to general aerosol products. The service being offered by Melbourn is therefore an important first stage in helping to inform industry.”