Ceepackaging

Products

Recirculation: Downtime without Consequences

During the filling and packaging process, suspensions with their solids being finely spread in the liquid should always be in motion so that the suspended solids cannot deposit and the mixing ratio maintained.  However, during the restart of equipment after a machine stop, it was usual and inevitable to reject the first syringe tubs, since the composition of solid and liquid components could not be guaranteed in the first fillings.  During the machine stop, the product also “stopped” and the suspended solids deposited. The solution now provides time saving, apart from the savings of product and packaging. When restarting the machine, a direct change to the “production mode” is possible and no further interventions into the filling and packaging process are required.

Better use of product

The filling and packaging machine is equipped with a reaction section, where the processing on the Inova machine starts. The tubs where the prefilled syringes are nested, are protected by a foil bag.  First, the outer protection layer is sanitized via the reaction section by means of alcohol. The closed bags then enter the laminar flow zone. Here, the Inova debagger automatically cuts the foil bags and the tub is pulled out of the film by means of vacuum grippers. There is still a second protection layer on the tub: The Tyvek foil is removed by the Inova TTR robot from corner to corner and disposed of, followed by the second work step to remove and deposit a third protection film.

The path to the combined filling and closing machine Inova SV125 is clear. The entire syringe nest is lifted out of the tub, swiveled, and placed in filling position.  The syringes can now be filled row by row by means of rotary five-position piston pumps. Here, the recirculation system waits for its operation: The high-precision recirculation valve is located directly before the filling needles. If an interruption of the filling and packaging process occurs, even the smallest quantities of the suspension can be redistributed.  Immediately after, the prefilled syringes are secured with plugs fed from an automatic sorting bowl.  The sterile plugs are refilled into the sorting bowl of the RABS system via an RTP transfer.

After the nest containing the filled and closed syringes has been placed back into its initial tub, the same passes a random sampling station.  An ink jet printer then prints a code onto the tubs.  All information is received from the central machine control system. 

The whole filling and closing line currently handles sizes from 1 to 3 ml, achieving a filling accuracy of 0.1 srel. The output amounts to 9,500 syringes per hour. Size changes can easily accomplished, mainly through the machine control system. Approx. 20 minutes is needed to change the machine to a new format.

Adapted: A lot of function for a small sterile area

The Optima Group Pharma project managers have developed and installed the machine in cooperation with the customer. A particular challenge was the predetermined confined sterile area in which the machine would be placed.  An elevator installed before the discharge of the products, as well as a swiveling conveyor belt are space-saving solutions to prove that a small area can house a lot of machinery without functional restrictions.  A smooth product flow, clear arrangement of the machine and altogether compact dimensions complement each other in an excellent way.

Due to the fact that the extent of the project during implementation was substantially increased, is a proven sign of great cooperation.  Initially, Inova was only to supply the robot and the filling and closing machine. Then, the debagger unit with the reaction section and the laminar flow unit were added, which enhanced the project volume by approx. 50 %. The entire project materialized within twelve months including the four weeks installation time.  During that period, the commissioning, including installation, start-up and SAT, was implemented.