G_Great
P_Performance

E_Engineering

G_Great
RTU disposable special syringe for customised filling and primary packaging of a pharmaceutical product for the treatment of bladder dysfunction. Without the need to affix labels with adhesive. For long-term storage.
P_Performance
Development, engineering and production of the three-part disposable syringe including siliconisation (stick-slip effect), scale and customised laser marking.
E_Engineering
One-of-a-kind expertise in processing the high-performance plastic COC Topas.

Disposable special syringe for pharmaceuticals to treat bladder dysfunction or rather 3-part disposable syringe with Luer lock made of the high-performance plastic COC Topas

The task

Development and production of a three-part disposable syringe (barrel, plunger, plug) with Luer lock connection made of a high-performance plastic (COC Topas) for the Grachtenhaus pharmacy. The RTU (ready-to-use) syringe was intended to serve as the primary packaging material for a pharmaceutical product manufactured by the customer to treat bladder dysfunction. GPE was brought on board as a development and production partner because the required quantity (up to 1 million units) is of little interest to the established syringe manufacturers, and therefore the customer’s supply was not guaranteed.

The challenges

The customer’s specifications with respect to the material properties – above all, excellent barrier properties to enable long-term storage of the drug, which normally only glass syringes can achieve – were the decisive aspect. Furthermore, the syringe was also subject to standard specifications regarding sliding and breakaway torque. In addition, the customer wanted to avoid the need to manually label the syringes in future, for example to apply the scale. The entire manufacturing process also needed to be carried out under class 7 clean room conditions according to DIN EN ISO 14644.

The solution

GPE possesses one-of-a-kind expertise in processing the high-performance plastic COC Topas, which has excellent barrier properties. In addition, no heavy metals and/or ions are released, and the particle level is lower than with glass syringes. The powerful moisture barrier of the cyclic olefin copolymer (COC) makes it possible to store pharmaceuticals for long periods of time, even in smaller syringes.

GPE designed the syringe components according to the applicable standard specifications and engineered the corresponding injection moulds and the associated automation. This encompasses, among other processes, the handling technology, siliconisation of the syringe barrel, laser marking and packaging.

GPE achieved the necessary sliding forces and breakaway torque pursuant to the standard specifications through the systematic use of a siliconised barrel interior and harmonising the tight fit between the syringe barrel and plunger stopper (the ‘stick-slip phenomenon’).

To spare the customer the effort of affixing a band with adhesive, a change in colour is realised by means of laser marking. The laser batch printing machine used for this purpose was adapted to GPE’s processes and equipment. Adding the scale by laser allows the syringe bodies to be marked with a logo selected by the customer and a QR code containing all of the relevant product information including the batch number.

The entire manufacturing process is carried out under class 7 clean room conditions according to DIN EN ISO 14644-1, from the injection moulding process in an enclosure with a laminar flow cabinet to automation, lasering and siliconisation (each with ventilation) as well as packaging.

The application and the added value

A heightened presence and greater flexibility in the market – thanks to the solution developed by GPE, customers can add a customised label to their own product and sell it on the market. Changes in needs can be realised quickly. Due to its independence from well-known syringe manufacturers, it is also possible to resell the syringe as a medical device (without a pharmaceutical) to third parties. By far the greatest benefit to the customer as a result of the development partnership is the unique disposable special syringe from GPE, a primary packaging material for a promising new pharmaceutical product used in the treatment of bladder dysfunction.