GiroNEX has announced a move into the pharmaceutical manufacturing equipment market with the launch of its Cube Plus automated precision powder dispensing system for use in manufacturing powder-filled capsules and vials for early phase clinical trials and related drug development studies.
The new Cube Plus system has been specifically developed to target a significant gap in the market between powder dispensing systems to help automate routine R&D laboratory ‘fill and weigh’ tasks, and high volume pharmaceutical capsule-filling machines. The Cube Plus is a flexible and cost-effective batch manufacturing system with a compact footprint and full FDA CFR21 Part 11 compliance to ensure complete data integrity and security.
The Cube Plus uses a 24-well dial plate and can quickly dispense from one milligram to one gram of single or formulated pharmaceutical powders into each capsule with an accuracy better than +/- two percent. It can be easily used by companies such as contract development and manufacturing organisations (CDMOs) to prepare batches of a few hundred or thousand capsules as required, and can also be used to fill vials or syringes.
“GiroNEX has worked closely with a number of CDMOs to help guide the design and development of the Cube Plus system and to ensure it meets the pharmaceutical industry’s need for a flexible and reliable capsule-filling system for use in early clinical studies. The Cube Plus builds on the same core powder dispensing principles as the company’s existing Cube system for laboratory R&D applications but has been specifically designed with dedicated software and a graphical user interface for use in regulated production environments,” said James Veale, product manager at GiroNEX.
The Cube Plus features controlled user access levels and records all user details, capsule weights to the nearest microgram, and other information into secure electronic records to comply with FDA 21 CFR Part 11 regulations for pharmaceutical manufacturing. GiroNEX can also supply a complete package of validation documents for GMP compliance at the customer’s premises as required.
The GiroNEX Cube and Cube Plus systems both fully exploit the significant cost and performance benefits of the company’s unique precision powder dispensing technology, launched last year. The systems are designed to work with re-usable stainless steel powder dispensing heads and are supplied with a series of interchangeable heads covering a broad range of powder types and behaviours. In addition, the AI-driven dispensing technology continuously characterises the powder’s behaviour during every dispense to virtually eliminate the need for time-consuming methods development and to fully optimise dispense times and cycles autonomously.
The Cube Plus system will be shown to the wider market for the first time on the GiroNEX stand (N13) at this year’s Lab Innovations event (NEC, Birmingham; 30/31 October).