Security first
Ready-to-use syringes offer pharmaceuticals manufacturers a significantly shorter process chain in their filling and making-up operations nowadays. Laser-coded packaging now also increases security.
Pre-filled syringes are the modern form of application for parenterally administered, highly effective medicines. World demand for this type of pharmaceutical packaging is therefore growing rapidly, especially in the ready-to-use version. Gerresheimer AG, Düsseldorf, is one of a small number of companies worldwide that can supply complete ready-to-fill injection systems to the pharmaceuticals industry, enabling the latter to outsource elaborate processes, from washing and drying the syringes to siliconizing and sterilisation and assembly.
Gerresheimer now offers laser encoding, a new form of identity labelling for pre-fillable glass syringes and other types of tubular glass drugs packaging. In the case of syringes, the code appears on the finger rest; on bottles, on the top edge: hardly visible to the naked eye, and even when optically enlarged it reveals no information. Special scanners are needed to decode the exact glass product concerned and to find out when and in which batch it was manufactured and for which type of drugs it has been specifically equipped, if applicable. This system allows different kinds of primary packaging which may look the same but can in fact have very different properties to be clearly identified at any time. Drugs manufacturers can of course also specify individual details they wish to have preserved through encoding on the glass.
Laser-inscribed in glass
Laser encoding is primarily Gerresheimer's custom track-and-trace solution to the documented traceability of medicines discussed by the EMEA (European Medicines Evaluation Agency) and the FDA (Food and Drug Administration), with the intention of combating the steadily growing global market in inferior product imitations. A deciding factor with this solution is the special laser technology, which as far as possible prevents any subsequent tampering with the tiny matrix data field. With the Gerresheimer process the code is imprinted not on the surface but actually into the glass, in other words, it is permanently burned into the glass. Inadvertent damage or any attempts to remove the product ID that has been so precisely engraved will be detected in the originality test under the reader, if not before. Another advantage of the burning-in laser technique is that no particles are released.
Modular filling and closing lines
The entire processing chain from compliant filling through to labelling of the ready-to-use syringes demands not only high-performance equipment but also, and increasingly, entry-level versions for the mid performance range. The modular machine combination from Bausch+Ströbel GmbH & Co. KG, Ilshofen, enables disposable syringes to be processed entirely automatically and in accordance with pharmaceutical standards, with a throughput of up to 5,100 units in the filling and closing area and 4,000 units per hour in the labelling area. The machine concept can be upgraded by adding further modules later on if necessary.
The first module is the SFM 5110 syringe filling and closing machine. The compact PLC-controlled monoblock machine is used to process disposable syringes according to the patented Hypac SCF method or similar systems. The design, structure and arrangement of all the units guarantee effective LF flooding for operation to pharmaceutical standards in the sterile area. The steps of dosing and inserting the plunger stoppers are carried out entirely automatically. The dosing range per pump is between 0.15 and 50 ml. The downstream transport operations take place automatically. The nested sterile syringe bodies are transferred to the transport system and moved precisely into position below the work stations. Filling and inserting the plunger stoppers take place via a two-position system. Centring of the objects and the freely programmable filling needle movement ensure optimum dosing results. Immediately after that, the plunger stoppers are positioned at the desired insertion height above the filling level without exerting pressure.
Electronic and visual control
The second module, the SET 8090 syringe removing machine, first removes the nest from the tub. The filled and closed syringe bodies are then lifted from the nest in rows. This allows the subsequent steps in the operation to be carried out in individual transport mode, suspended by the finger rest. The empty nests are automatically ejected into bins.
The third module is the TVK 7070 transporter, for visual control of the filled, sealed syringe bodies. The objects rotate as they travel, singly and continuously, past an illuminating device as the operator examines them visually with the aid of a magnifying glass. Any defective objects can be removed manually before they enter the area of the downstream labelling machine.
The ESS 1001 PLC-controlled labelling machine, the fourth module, works in cycles at up to 4,000 units/h and is a compact complete solution for labelling and inserting plunger rods into the syringe bodies immediately following inspection. The label dispenser is controlled by a stepping motor and automatically ensures gentle, secure belt transport according to the particular label length, thus guaranteeing that every single object is precision-labelled. All the machine functions are controlled and monitored by a series of electronic control devices.
The plunger rods are inserted or screwed into the plunger stoppers immediately before labelling. These plastic parts are fed in bulk via a transport combination consisting of a vibratory sorter in conjunction with a linear conveyor. The plunger rods are thus conveyed singly to the inserting tools, ready for processing. The pressure created inside the syringe when the rod is inserted is relieved by pulling back the plunger rod.
