The most recent technology of Vertus® automated shake and fireplace platforms from Copley Scientific make it straightforward 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, totally automated benchtop system for pressurised metered dose inhaler (MDI), nasal spray and nasal aerosol testing. Comprehensively up to date to satisfy testing necessities for an excellent wider vary of machine varieties, it incorporates a better 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 units underneath an identical situations to these utilized by the Vertus III+. Each characteristic 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 medical panorama has resulted in a surge of exercise in MDI reformulation and nasal drug product growth; the Vertus platform may also help considerably scale back the related burden of routine evaluation. Automated shake and fireplace techniques get rid of any requirement for handbook machine actuation, simulating machine dealing with by the affected person through parameters corresponding to shaking motion, time between doses, and actuation power profile. Via life testing for MDIs, which requires the firing of a whole lot of doses to waste, and regulatory steering that recommends a ‘mechanical technique of actuating the pump meeting be employed’ for spraysi are notable drivers for adoption.
The brand new Vertus techniques are compliant with each pharmacopoeial specs and 21 CFR Half 11. Vertus and DecaVertus share an arc-like shaking movement per typical analyst approach, enabling machine 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 power ranges have been elevated relative to earlier fashions for better flexibility with respect to check configuration.
Different key options of the brand new Vertus III+ embody:
- Built-in shot weight measurement for fast and environment friendly Uniformity of Delivered Mass testing for nasal answer merchandise, in keeping with compendial specs.
- A re-engineered exhaust port for easy connection to airflow extraction, making it simpler to deal with extremely potent medicine and extra flammable propellants corresponding to HFA152a, a low international warming candidate for MDI reformulation.
- A big, adjustable display and intuitive person interface permitting straightforward interplay with minimal coaching.
- A brand new built-in priming and waste module for streamlined, automated testing, notably throughout your complete contents, with minimal handbook enter.
- An in depth vary of interchangeable interface plates for take a look at equipment corresponding to a Spray Drive 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 concerning the subsequent technology of the Vertus household and the way they might rework your testing observe.
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 tools and is a serious supplier of testing techniques for different pharmaceutical dosage kinds. The corporate additionally provides tools for detergent testing.
Copley’s pharmaceutical product vary contains testing tools for every type of orally inhaled and nasal drug merchandise – metered-dose inhalers, dry powder inhalers, nebulisers and nasal merchandise – with a selected give attention to options for delivered dose uniformity and aerodynamic particle dimension distribution measurement. It additionally contains testers for tablets (dissolution, disintegration, friability and hardness) capsules, powders, suppositories, semisolids and transdermals.
Used from R&D by to QC, this intensive vary of apparatus is supported by a full validation and aftersales service. Copley works in partnership with specialist distributors, extending localised assist internationally. This community offers professional assist and coaching to each buyer, straight enhancing the applying of all Copley merchandise. www.copleyscientific.co