09 January 2024; Nottingham, UK: New literature from Copley Scientific, the world’s leading manufacturer and supplier of inhaled product testing equipment, highlights the importance of controlling temperature, relative humidity (RH) and electrostatics in the test environment to maximise the integrity and value of inhaler test data. In an application note and white paper, company experts provide insight into the issues and practical guidance for improvement including experimental data demonstrating the performance of EnviroMate™, a benchtop environmental control chamber for inhaler testing. An interesting and informative read for anyone looking to minimise variability in inhaler testing, the new literature is freely available for download.
“Variability in the test environment is a frequently overlooked contributor to poor quality data and out-of-specification results,” said Clair Brooks, Applications Specialist, Copley. “This white paper explains the links between test environment, orally inhaled product (OIP) performance and measured metrics, while the app note provides experimental evidence showing how EnviroMate can help. Both make good reading for those with a problem with temperature, RH or electrostatics control within the lab.”
‘Establishing a robust environment for inhaler testing’, the recently released white paper, addresses questions such as:
- Why is OIP testing prone to variability?
- What is the economic impact?
- How do changes in temperature, RH and electrostatic charge affect the performance of different classes of OIP – nebuliser, metered dose inhaler and dry powder inhaler?
- How can environmental conditions influence cascade impactor measurements?
- What strategies and solutions are available to improve environmental control?
‘Reducing variability in the inhaler testing environment’ is a complementary application note detailing an experimental study of the performance of an EnviroMate. The resulting data show how the unit delivers constant temperature and RH in the face of variability in an air-conditioned lab typical of those used for inhaler testing.
“During training, customers routinely ask how to tackle sources of variability and improve data integrity, so we’re delighted to add these valuable pieces to our literature library,” concludes Brooks.
New literature from Copley explains the multiple impacts of temperature, RH and electrostatics on inhaler test data and discusses strategies for mitigation.
About Copley Scientific
Copley Scientific is widely recognised as the world’s leading manufacturer and supplier of inhaled product testing equipment and is a major provider of testing systems for other pharmaceutical dosage forms. The company also supplies equipment for detergent testing.
Copley’s pharmaceutical product range includes testing equipment for all types of orally inhaled and nasal drug products – metered-dose inhalers, dry powder inhalers, nebulisers and nasal products – with a particular focus on solutions for delivered dose uniformity and aerodynamic particle size distribution measurement. It also includes testers for tablets (dissolution, disintegration, friability and hardness) capsules, powders, suppositories, semisolids and transdermals.
Used from R&D through to QC, this extensive range of equipment is supported by a full validation and aftersales service. Copley works in partnership with specialist distributors, extending localised support across the world. This network provides expert help and training to every customer, directly enhancing the application of all Copley products. www.copleyscientific.com