The newest era of Vertus® automated shake and fireplace platforms from Copley Scientific make it simple and intuitive to combine automation into a variety of drug product testing workflows to spice up productiveness, drive down take a look at variability, and simplify coaching. The Vertus® III+ is the corporate’s new flagship, absolutely automated benchtop system for pressurised metered dose inhaler (MDI), nasal spray and nasal aerosol testing. Comprehensively up to date to satisfy testing necessities for a good wider vary of gadget varieties, it incorporates a larger array of interchangeable take a look at plates and, built-in shot weight measurement. The DecaVertus® III is a complementary, excessive throughput answer for firing-to-waste, with the capability to concurrently discharge 10 gadgets below similar circumstances to these utilized by the Vertus III+. Each function a brand new exhaust system that eases the dealing with of extremely flammable propellants. Collectively they current a compelling, extremely efficient answer for product testing.
The present regulatory and scientific panorama has resulted in a surge of exercise in MDI reformulation and nasal drug product growth; the Vertus platform can assist considerably scale back the related burden of routine evaluation. Automated shake and fireplace programs remove any requirement for guide gadget actuation, simulating gadget dealing with by the affected person through parameters akin to shaking motion, time between doses, and actuation pressure profile. By means of life testing for MDIs, which requires the firing of a whole bunch of doses to waste, and regulatory steerage that recommends a ‘mechanical technique of actuating the pump meeting be employed’ for spraysi are notable drivers for adoption.
The brand new Vertus programs are compliant with each pharmacopoeial specs and 21 CFR Half 11. Vertus and DecaVertus share an arc-like shaking movement in step with typical analyst method, enabling gadget actuation strategies developed on the Vertus to be transferred on to, and rigorously replicated on, the DecaVertus for firing-to-waste. Each shaking angle and firing pressure ranges have been elevated relative to earlier fashions for larger flexibility with respect to check configuration.
Different key options of the brand new Vertus III+ embody:
- Built-in shot weight measurement for speedy and environment friendly Uniformity of Delivered Mass testing for nasal answer merchandise, in step with compendial specs.
- A re-engineered exhaust port for easy connection to airflow extraction, making it simpler to deal with extremely potent medication and extra flammable propellants akin to HFA152a, a low world warming candidate for MDI reformulation.
- A big, adjustable display screen and intuitive person interface permitting simple interplay with minimal coaching.
- A brand new built-in priming and waste module for streamlined, automated testing, notably throughout the complete contents, with minimal guide enter.
- An in depth vary of interchangeable interface plates for take a look at equipment akin to a Spray Power Tester, Skinny Layer Chromatography plates (for spray sample), Alberta Idealised Throat and Alberta Idealised Nasal Inlet, for the great testing of each innovator and generic merchandise.
Discover out extra in regards to the subsequent era of the Vertus household and the way they may remodel your testing follow.
Picture Credit score: Copley Scientific
About Copley Scientific
Copley Scientific is broadly recognised because the world’s main producer and provider of inhaled product testing gear and is a serious supplier of testing programs for different pharmaceutical dosage kinds. The corporate additionally provides gear for detergent testing.
Copley’s pharmaceutical product vary consists of testing gear for every type of orally inhaled and nasal drug merchandise – metered-dose inhalers, dry powder inhalers, nebulisers and nasal merchandise – with a specific concentrate on options for delivered dose uniformity and aerodynamic particle measurement distribution measurement. It additionally consists of testers for tablets (dissolution, disintegration, friability and hardness) capsules, powders, suppositories, semisolids and transdermals.
Used from R&D by to QC, this in depth vary of kit is supported by a full validation and aftersales service. Copley works in partnership with specialist distributors, extending localised help the world over. This community offers skilled assist and coaching to each buyer, straight enhancing the applying of all Copley merchandise. www.copleyscientific.co
