New, automated shake and hearth platforms from Copley reduce the burden of MDI and nasal drug product testing.

The most recent era of Vertus^® automated shake and hearth 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 system sorts, 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 beneath similar 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 scientific panorama has resulted in a surge of exercise in MDI reformulation and nasal drug product growth; the Vertus platform can assist considerably cut back the related burden of routine evaluation. Automated shake and hearth programs eradicate any requirement for guide system actuation, simulating system dealing with by the affected person through parameters reminiscent of shaking motion, time between doses, and actuation drive profile. By way of life testing for MDIs, which requires the firing of lots of 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 programs are compliant with each pharmacopoeial specs and 21 CFR Half 11.  Vertus and DecaVertus share an arc-like shaking movement in line with typical analyst approach, enabling system 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 drive 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+ embrace:

• Built-in shot weight measurement for fast 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 reminiscent of HFA152a, a low world warming candidate for MDI reformulation.
• A big, adjustable display screen and intuitive consumer interface permitting simple interplay with minimal coaching.
• A brand new built-in priming and waste module for streamlined, automated testing, notably throughout your complete contents, with minimal guide enter.
• An in depth vary of interchangeable interface plates for take a look at equipment reminiscent of a Spray Power Tester, Skinny Layer Chromatography plates (for spray sample), Alberta Idealised Throat and Alberta Idealised Nasal Inlet, for the excellent testing of each innovator and generic merchandise.

Discover out extra concerning the subsequent era of the Vertus household and the way they may remodel your testing apply.

About Copley Scientific

Copley Scientific is extensively 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 types. The corporate additionally provides gear for detergent testing.

Copley’s pharmaceutical product vary contains testing gear for all sorts of orally inhaled and nasal drug merchandise – metered-dose inhalers, dry powder inhalers, nebulisers and nasal merchandise – with a selected deal with options for delivered dose uniformity and aerodynamic particle measurement distribution measurement. It additionally contains testers for tablets (dissolution, disintegration, friability and hardness) capsules, powders, suppositories, semisolids and transdermals.

Used from R&D by way of 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 internationally. This community offers knowledgeable assist and coaching to each buyer, immediately enhancing the applying of all Copley merchandise. www.copleyscientific.co