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 came 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. Since April 29, manufacturers of personal and domestic aerosol dispensers have been 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. 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.”
