When purchasing machines specifically designed to process eye drops, Jubilant Pharma had two requirements: Flexibility and compact design. As a CDMO, Jubilant impresses customers with high efficiency and precise weighing results because ultimately, this leads to higher yields per batch.
For this project, a four-headed OPTIMA VFVM 10000 was used to implement the specific customer requirements. Jubilant, a CDMO in the ophthalmology industry pays great attention to high performance, high dosing accuracy, and flexibility in terms of varying viscosities and container types. The VFVM10000 offers Jubilant the opportunity to process eye drop bottles in combination with a variety of closure types including preservative free technology.
Jubilant has opted for two filling systems that are permanently installed in the machine. A disposable product path with peristaltic pumps is used as standard. The vertical arrangement of the four peristaltic pumps saves a considerable amount of space.
Since ophthalmic drugs are sometimes viscous, rotary pumps can also be used for dosing viscous products with high precision. Both pump types operate in four-digit versions. The OPTIMA VFVM achieves an output of up to 12,000 containers per hour.
Jubilant uses containers that are consistent in weight. The format-related weights are stored in the checkweigher control system; the gross tare weighing provides efficient 100% fill weight control with no loss of performance. Containers with gross weights outside the defined tolerances are rejected. The metering parameters are continuously adjusted based on the fill weights registered and analyzed by the control system. This ensures consistently high precision filling performance, giving CDMOs like Jubilant “weighty” arguments in its favor.
The production process with the OPTIMA VFVM10000 starts with the sorting of the containers and feeding them into the machine with a centrifuge. The correctly oriented bottles are transferred to the filling and closing station via a star wheel and segment wheel configuration to the linear walking beam transport system.
After the filling process is completed the containers are transferred to the closing station with its specifically designed closing technology, depending on container type. Conventional plastic bottles are fitted with a dropper for dispensing the eye drops. The droppers are transported in a four-lane configuration and inserted into the container with pick & place technology. Optional available: Nitrogen gassing to minimize oxygen in the container.
Twist closure caps are placed via a pre-capping station followed by a final cap torque station.This ensures that always the correct torque force is used and therefore containers are always easy to open. The final torque station also measures removal torque as requested or on a sampling basis.
Once the closing inspection is completed, the finished containers are transferred to a double tray loading configuration at the discharge of the machine. Containers that do not meet the inspection criteria are rejected. The trays, containing only “good” vials, are removed at the end of the line.
During the implementation phase, Jubilant chose also to process specific types of preservative free OSD technology. The technology consists of flexible bottles and pre-assembled, multi-part closures with integrated droppers and caps. For easy use, OSD caps are opened by tearing off a plastic tab on the cap.
Additional processing of the preservative free OSD technology was made possible and optimized by making design changes to the OPTIMA VFVM. Now, Jubilant Pharma has the flexibility to easily switch between preservative free OSD or conventional screw closures with dedicated change parts – like a typical format change. For instance, the format parts are located in the bottle feeding centrifuge and the conveyor for the screw caps, erecting the bottles. Sorting, feeding, and pushing the specific OSD closures into the flexible bottles are also carried out by simply using format parts, without time-consuming conversions. A special holder has been developed for pressing in the caps. This ensures stability when pressing the closures into the vials.
In addition to being compact and flexible, high filling accuracy was very important for Jubilant. This was demonstrated in the FAT/SAT with an OEE (Overall Equipment Efficiency) exceeding 90% efficiency. Direct service from a North American subsidiary was another key deciding factor for Jubilant Pharma when awarding the contract. Optima Machinery Corporation has now two locations in the U.S. and the Jubilant account will be handled by Optima Machinery Corporation, Green Bay (WI).
One additional challenge was the limited space available at Jubilant’s facility. The VFVM’s compact design with stacked peristaltic pump dosing system resolves this issue. The system also had to be dismantled and reassembled on site in order to bring it into the production room. At Jubilant, the OPTIMA VFVM is operated in a Grade B cleanroom environment, therefore the system features Active Open RABS with integrated laminar flow unit above the filling area and additional laminar flow units outside the machine guarding, extending from the door opening zone to the room walls. In total, nine laminar flow modules are operating in the room.
Over the course of the project, the Jubilant Pharma project team had the opportunity to be on site at Optima in Schwäbisch Hall, Germany, for the key milestones such as the mock-up study, the design review, and the machine factory acceptance test (FAT), despite the restrictions during the Covid-19 pandemic. By October 2021, the system passed the customer's site acceptance test (SAT) at Jubilant in Canada. After qualification, it was commissioned for commercial manufacturing projects for pharmaceutical companies in the ophthalmology sector.