07 November 2023; Nottingham, UK: The latest generation of Vertus® automated shake and fire platforms from Copley Scientific make it easy and intuitive to integrate automation into a wide range of drug product testing workflows to boost productivity, drive down test variability, and simplify training. The Vertus® III+ is the company’s new flagship, fully automated benchtop system for pressurised metered dose inhaler (MDI), nasal spray and nasal aerosol testing. Comprehensively updated to meet testing requirements for an even wider range of device types, it incorporates a greater array of interchangeable test plates and, integrated shot weight measurement. The DecaVertus® III is a complementary, high throughput solution for firing-to-waste, with the capacity to simultaneously discharge 10 devices under identical conditions to those applied by the Vertus III+. Both feature a new exhaust system that eases the handling of highly flammable propellants. Together they present a compelling, highly effective solution for product testing.
The current regulatory and clinical landscape has resulted in a surge of activity in MDI reformulation and nasal drug product development; the Vertus platform can help significantly reduce the associated burden of routine analysis. Automated shake and fire systems eliminate any requirement for manual device actuation, simulating device handling by the patient via parameters such as shaking action, time between doses, and actuation force profile. Through life testing for MDIs, which requires the firing of hundreds of doses to waste, and regulatory guidance that recommends a ‘mechanical means of actuating the pump assembly be employed’ for spraysi are notable drivers for adoption.
The new Vertus systems are compliant with both pharmacopoeial specifications and 21 CFR Part 11. Vertus and DecaVertus share an arc-like shaking motion consistent with typical analyst technique, enabling device actuation methods developed on the Vertus to be transferred directly to, and rigorously replicated on, the DecaVertus for firing-to-waste. Both shaking angle and firing force ranges have been increased relative to previous models for greater flexibility with respect to test configuration.
Other key features of the new Vertus III+ include:
- Integrated shot weight measurement for rapid and efficient Uniformity of Delivered Mass testing for nasal solution products, in line with compendial specifications.
- A re-engineered exhaust port for simple connection to airflow extraction, making it easier to handle highly potent drugs and more flammable propellants such as HFA152a, a low global warming candidate for MDI reformulation.
- A large, adjustable screen and intuitive user interface allowing easy interaction with minimal training.
- A new integrated priming and waste module for streamlined, automated testing, notably across the entire contents, with minimal manual input.
- An extensive range of interchangeable interface plates for test apparatus such as a Spray Force Tester, Thin Layer Chromatography plates (for spray pattern), Alberta Idealised Throat and Alberta Idealised Nasal Inlet, for the comprehensive testing of both innovator and generic products.
Find out more about the next generation of the Vertus family and how they could transform your testing practice.
i US Pharmacopoeia Chapter <601> ‘Aerosols, Nasal Sprays, Metered Dose Inhalers and Dry Powder Inhalers’
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
