Following our vocation for innovation and quality, Dara Pharma is proud to present a new all in one multiformat line for vaccine production in RTU & Bulk. Dara Pharma has developed this Combi line for washing, sterilizing, filling, freeze-drying, and closing vials in bulk; and for denesting, filling, and closing RTU syringes and cartridges, with quick and easy format changeovers, to make the vaccine packaging process more cost-effective for the customer.
Dara Pharma has integrated into this “all-in-one” solution its state-of-the-art filling machines that have revolutionized the aseptic packaging machinery sector thanks to their versatility and flexibility to process liquid, semi-solid, and powder products in the same equipment.
The line has a washing machine and a sterilization and depyrogenation tunnel for bulk supply. Our washing machine offers maximum efficiency and high flexibility to process any format, while the sterilization & depyrogenation tunnel provides the highest flexibility and adaptability, lowest consumptions, and easy maintenance thanks to our modular design.
For the RTU processing (Ready-to-use), the line counts on automatic debagging, delidding, and denesting modules for supply the nests and trays.
This solution offers different production speeds thanks to Dara Pharma’s VSC multiformat filling and closing machine, with a maximum output of up to 24,000 uph, a dosage range of 0.1 to 100 ml, and 100% IPC. The line’s closing machines control and measure the parameters required in this process, such as torque, crimp pressure, closing height, and any visual control – guaranteeing that the products are closed satisfactorily.
In addition, Dara Pharma integrates into this line Coolvacuum’s LyoCool GMP freeze dryer and the automatic loading system to connect the freeze dryer with the rest of the line’s equipment. The freeze-drying process allows for extending the shelf life of the product while maintaining its qualitative properties. For this, Dara and Coolvacuum integrate into this solution the LyoCool GMP freeze dryer, which offers from 7 to 15 m² of shelf area, and a condenser capacity of up to 250 kg.
For automatizing the loading and unloading of the products from the freeze dryer, Dara offers the VLS (Vial Loading System), a row-by-row system with a push-in cylinder / push-out cylinder. This system offers an output of up to 12,000 uph.
Another advantage worth highlighting about this solution is that Dara can integrate all the processes for them to be performed under an isolator, offering the highest level of protection for the products. Other protection equipment such as LAF, oRABS, or cRABScan be as well integrated into the line at the customer’s choice.
By designing, manufacturing, and adjusting the transfer system for the correct integration of all the machines, Dara Pharma acts as a unique supplier of the line. Furthermore, our company configures a control system for all the line’s equipment to operate under the same software and data acquisition system. SCADA software has been designed in accordance with FDA 21CFR Part 11.
That simplifies the process of installation and commissioning of the solution at the customer’s plant, while our complete maintenance plan ensures that all machines will operate optimally and efficiently in the long term.
Learn more about this line: https://www.dara-pharma.com/en/34-aseptic-vaccine-production-multiformat-complete-line.
