Point of interest
The Gerresheimer Bünde facility is continually growing. As well as boasting a new building complex, a fourth production line is being commissioned. With around 800 employees this is Gerresheimer’s Group’s competence centre for ready-to-fill glass syringes
When you seen the new building complex at this Gerresheimer plant, it’s hard to imagine that the company was founded back in 1947 as Bünder Glas by the Hennings and Zimmermann families. Gerresheimer took over Bünder Glas in 1987 and since then it has gradually developed it into an international specialist for sterile ready-to-fill syringes which are marketed under the Gx RTF (Gerresheimer Ready-to-Fill) brand name.
Glass ready-to-fill syringes are supplied to pharma and biotech customers around the world, where they are filled with pharmaceuticals. Gerresheimer has a comprehensive portfolio of sterile and non-sterile syringe systems. Gx RTF syringe systems are supplied to the customer in a ready-to-fill state - washed, siliconised, pre-assembled with cap and sterilised.
The new production bay
The fourth production line for ready-to-fill syringes is currently being commissioned in the new production bay. Key process improvements include the avoidance of glass-glass and glass-metal contact through the use of pick-and-place robots and segment transport systems, optimized washing and siliconisation processes and more effective, camera-based quality inspections. This gentle handling results in a lower syringe cosmetic defect rate. A new washing process guarantees even better compliance with both present-day and future regulatory requirements. Improved spraying technology and 100% in-line inspections in the siliconisation process ensure consistent syringe function. All these measures improve the syringes’ processability during the filling process and their general function. The syringes from all production lines are packed into PP boxes in clean room environments to ensure maximum product hygiene.
The first RTF production line was installed and commissioned at the Bünde plant in 2001. Before long, the RTF syringes were a major success on the international markets.
Two further production lines were subsequently installed, followed by the fourth RTF line in Bünde ten years later. Today syringes account for the majority of Bünde’s production output, and it will have the capacity to manufacture over 400 million RTF syringes when the RTF4 line is put into operation at the end of 2014.
Bünde has 24/7 production operations because this is the only way to exploit the plant’s capacity to the maximum while maintaining stable processes and quality.
Maximum syringe quality
Syringes are primary packaging products, which means that they come in direct contact with the medication. That’s why utmost care must be taken when manufacturing them. The syringe has to be perfectly clean because even the tiniest amount of contamination could alter the medication. The syringe also has to be absolutely intact. It cannot have cracks and must be firmly sealed so that no germs can come into contact with the medication.
The inside of the syringe is coated with silicone to ensure that the plunger can slide up and down it. The rule of thumb is to use as little silicone as possible and as much as necessary. You have to use enough, because you want to make sure that the plunger will slide just as easily after three years of storage. But if you use too much, it can cause lumps to form in the medication.
When syringes are manufactured, each one of them is inspected several times - by cameras, sensors, computers and the human eye. Employees have special responsibility for ensuring that no patient suffers harm as a result of defective syringes.
Gerresheimer Bünde has been equipped for successful production operations which it looks set to build upon with the fourth production line.