The field of prefillable syringes is constantly turning up new developments, driven by new active ingredients and a desire for patient safety at an affordable cost. Gerresheimer explains how it responds to these trends with a series of innovations in accordance with the demands of the pharmaceutical industry, healthcare workers and patients.
Pharmaceutical customers want syringe systems that fulfil extremely strict requirements in terms of quality and can be filled with minimal problem, minimising additional costs.
Current approaches include ways of adapting syringe systems to new requirements of, for example, sensitive biotech-derived APIs. Some of these special drug formulations need dedicated syringe systems..
Development focuses upon facilitating higher dosage volumes for injections, dealing with higher viscosities and overcoming the sensitivity that the liquid formulation has to some of the syringe's individual components.
Patient safety when using syringes is always at the forefront of all research: technical properties - such as break loose and gliding forces - are crucial, especially when it comes to integration into autoinjectors.
FDA classifies prefilled syringes as a 'combination product'. Prefillable syringes are filled with a variety of medications: most of them are relatively expensive and produced using complex biotechnological processes. The end-user benefit of using a prefilled syringe instead of a vial is closely linked to ensuring that the injectable and syringe system work together smoothly.
As such, the requirements placed on the syringe as an interface between the medication and the patient are becoming increasingly demanding. The effective dosage needs to be injected accurately and safely. All the more important, then, to ensure that the syringe itself is of consistently high quality.
After all, it needs to be able to store the medication safely (primary packaging) and make the injection itself safe, patient-friendly and as painless as possible (injection device).
With this in mind, Gerresheimer has extensively investigated the function (break loose and gliding forces) with a number of plunger stoppers in order to help pharmaceutical customers choose the appropriate
The function of the syringe is also essential to its integration in autoinjectors, a factor that is becoming increasingly important.
In addition to the traditional (1ml long) syringe, a second important format (2.25ml) is becoming more common for certain applications. Subcutaneous injections using prefilled syringes for self administration used to be limited to the 1 ml long format in the past. Recently, some new developments in drug formulations are in need of larger syringes. By means of a 2.25ml staked needle syringe higher volumes of some new (less viscous but high volume) drug formulations now can be administered very easily within an acceptable time frame. In all these cases, high-volume syringes represent a significant expansion to the range of therapies a doctor can offer.
Among other products, Gerresheimer offers a 2.25ml syringe with staked-in needle that enables subcutaneous injection for such applications. Together with the matching stopper, this syringe is the perfect packaging and device for volumes of up to 2.25ml. A variety of caps and stoppers are available from many different manufacturers.
When the syringe is emptied into the tissue through the cannula, this leads to high backflow forces, making injection more difficult. The aim of making injections quick and painless can be achieved using needles with a larger inner diameter: thin-walled cannulas enable a higher flow rate, at a lower pressure. They also reduce shear forces, which can impair sensitive liquid formulations.
Gerresheimer caters to the requirements of modern injectables with its range of thin-walled cannulas. In addition to the traditional 27G cannulas, it also has 29G, 26G and 25G versions, as well as a 23G device for extremely viscous medications.
Two components of the syringe are of particular significance when it comes to interaction with sensitive medication: silicone oil, which is used as a lubricant, and tungsten/tungsten oxides, traces of which can remain from the manufacturing process for the glass body.
The former can be kept to a minimum using baked-on siliconisation, a process that Gerresheimer has offered for many years with its baked-on ready-to-fill (RTF) syringes. This ensures that far fewer particles remain in the syringe.
Traces of tungsten, meanwhile, can be significantly reduced by a special washing process, or avoided completely by using a special ceramic as an alternative pin material. These production techniques enable Gerresheimer to meet the strict requirements of its pharmaceutical customers and ensure that the ceramic pin is non-cytotoxic and abrasion-free.
Gerresheimer has carried out extensive studies on the break resistance of glass syringes. In addition to the break resistance of the finger flange, it is also possible to significantly improve the stability of the shoulder area and the cone. High break tolerance and compact dimensions are important parameters for a prefilled syringe, especially when using automatic injection systems.
The modern production technology used at Gerresheimer for glass forming, needle mounting and the RTF process ensures extremely high product quality.
Sophisticated G3 camera technology and transporting syringes individually during the RTF process to avoid glass-to-glass contact are just two examples of the measures the firm takes in order to improve quality for its customers and drastically minimise rejection rates.
Gerresheimer is constantly closely collaborating with its pharmaceutical customers and suppliers to develop and improve injection systems. Highly viscous and high-volume injections are just two examples of the developments in the administration of modern medication that a packaging manufacturer can address.
Gerresheimer's labs are fitted with the latest equipment and its production teams are staffed with experienced, highly trained workers. In addition to its own ideas, the company can also implement customer concepts within a predefined schedule and cost framework.