Filling Procedure |
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PROCESS AND TECHNIQUE |
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The process of aseptic filling where a sterile product is filled into medical containers without the need for further terminal sterilization is a particularly critical process that Transcoject has operated successfully for years. Accordingly, Transcoject is certified according to ISO 13408 for aseptic filling. Qualified rooms and machinery as well as validated processes guarantee a safe product. We regularly review the quality and safety of the filling process by validating the procedure by means of integrated Media Fills that meet current GMP requirements. At the core of our filling area is a laminar flow enclosure according to cleanroom class A, surrounded by a class B cleanroom. This enclosure is where we fill medical devices up to class III. At present, amongst others, we are filling syringes with urology products, in particular Gepan® Instill for Pohl Boskamp as well as Instillamed® for Farco Pharma (Klosterfrau group) Sterile filtration of media makes sense – and is equally safe – when heat sterilization is not feasible. In general, the filtration is effected using filters of a pore size of 0,2µm which reliably retain animate cells while allowing the dissolved ingredients of the medium to pass the filter without undergoing any transformation. Sterile filtration is a gentle treatment of media, i.e. active ingredients and auxiliary substances are not exposed to radiation or heat. Having in-house laboratories for incoming and outgoing inspection allows us to perform nearly all relevant tests at short notice, whether raw materials or finished products. For example, we perform the following tests: |
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bioburden | |
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osmolalität | |
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viscosity | |
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proportion of decisive integredients | |
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pH value | |
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endotoxins | |
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Those tests that we cannot perform on our premises are assigned to certified external laboratories. |
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ASSURE AN ASEPTIC AREA |
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The filling runs are executed with dedicated equipment. All components that are in direct contact with the prodct are made of pharmaceutical-grade stainless steel and are sterilized regularly prior to any new filling run. Particular elements such as filters or tubes are exchanged before commencing a new production campaign. Cleaning programmes describe the process in detail, designate the cleaning agents as well as disinfectants and define the time frame. All this is strictly controlled and recorded in protocols. For every batch, an individual ambient conditions monitoring is conducted, including air, surfaces and personnel. According to our zoning concept, every single step is regulated, from gowning of the specifically trained personnel and inward transfer of the materials, all via diverse air locks, up to the production area sensu stricto. It goes without saying that the basic microbial load of the primary chemical material is of crucial importance for the aseptic filling. Therefore, our incoming inspection checks incoming base chemicals meet the specified threshold.
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Filling |
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COMPLEX PROCESSES, MADE-TO_ORDER |
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The filling of medical-pharmaceutical products is one of our most important divisions. As a full-service provider who contributes to peoples’ well-being, we naturally set high quality and safety standards in filling, as well as in all other divisions of our company. The aseptic filling, by which a sterile product is filled into vessels without the need for further terminal sterilisation, is a particularly critical process that not only requires qualified systems but also an extremely thorough validation of the aseptic conditions throughout the entire filling process. At Transcoject, we have successfully carried through this process for a number of years. In order to cater to the needs of our customers, we have designed both our concept and our equipment to be as adaptable as possible; this enables us to develop individualised processes. |
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Filling Procedure | ||
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Process Design | ||
Syringe Cartrigdes |
_______________________________ CONTACT R&D : Mr. Marg Tel. +49 4321 885 832 _______________________________ |
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| PLASTIC INSTEAD OF BROKEN GLASS | ||||
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Syringe cartridges (cylindrical syringe ampoules) made from glass are a widely spread primary packaging, in particular used for anaesthetics in the dental field, but also employed in autoinjectors and pen systems. A well-known disadvantage of this packaging material, however, is breakage and bursting happening in the filling lines – and it is even more concerning when it happens in autoinjectors, where momentarily, extremely high pressure is exerted on the cartridge. Syringe cartridges made from plastic eliminate these problems, provided that the plastic material and the design are optimised for the appropriate pressure stability. In this context, Transcoject has developed a transfer device which serves to comfortably transfer the pharmaceutical solution from a bottle or vial into a syringe cartridge. A dedicated bayonet-connector stopper in combination with a corresponding piston allows the user to draw the medicine from a vial just like he would when using a syringe and, once the piston has been removed from the bayonet connector, the syringe cartridge can easily be inserted into the autoinjector or pen. This innovation and further adapted components make the reconstitution of lyophilised pharmaceutical preparation and the transfer of the reconstituted medication into the syringe cartridge easy and safe. We can also provide the single-use cannulas typically used in connection with syringe cartridges. |
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Sringes and Cartriges |
_______________________________ CONTACT R&D: Mr. Marg Tel. +49 4321 885 832 _______________________________ |
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| SYRINGES UP TO 20ML | ||||
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For diverse fields of application, Transcoject has developed small-volume syringes (1ml up to 20ml) made of COP that serve as primary packaging for parenteral drugs and is producing these, having a major output for some variations. All variations are delivered in standard nest and standard tub, EO-sterilized and thus „ready to fill“; this makes them compatible with most established filling lines. According to the customer’s desires and individual needs, the syringe design may be adapted, for example the shape of the grip plate. These syringes are producible both as Luer or as Luer-Lock. Furthermore, customised sterile packaging and single-use feeding systems for filling lines can be implemented.
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| CARDRIGES 50ML - 250ML | ||||
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Suited in particular for the application of contrast media, Transcoject has developed large-volume syringes respectively cartridges (50ml up to 250ml) made of COP and produces these through a dedicated manufacturing technology which guarantees virtually particle-free products. These products are delivered either nested and in tub (50ml) or in a special carrier system, EO‑sterilized and ready to fill. These transport packagings warrant safe transportation and a product with a scratch-free surface. The products were designed specifically for the application of high pressure (up to 300psi) to assure secure use in injection machines.
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| CLOSURE SYSTEMS - TAMPER EVIDENT CLOSURES AND MORE | ||||
| Transcoject disposes of diverse variations of tamper-evident closures which may be selected – and adapted – according to the intended use and specific demands. For example, by creating an individual colour design of the cap (or other non-fluid-path components), it is easy to achieve a simple, yet efficient product differentiation. | ||||
| SILICONE SYSTEMS | ||||
| Static friction and dynamic friction are crucial indicators both for manual use of a syringe and for the use in injection machines. By developing dedicated silicone systems which may be adapted to individual constraints, we have succeeded in realizing extremely low and constant friction values. | ||||
| PLUNGERS | ||||
| In addition to friction forces, sealing integrity, in particular after autoclaving, is the major parameter. Our years of experience with regard to plunger design and close cooperation with our partners and suppliers guarantees a meticulous calibration of materials, silicone system and the design of syringe, plunger and tip cap respectively tamper-evident closure. | ||||
| RAW MATERIALS | ||||
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Besides distinctly improved burst and breaking properties of the syringes and cartridges, the COP type used by Transcoject also features an exceptional gas and vapour barrier, all the while maintaining highest optical brilliance and transparency. The glass-like transparency of the material facilitates visual inspection of syringes and cartridges after filling on the filling lines. The choice of the plunger material depends upon the intended use and will be arranged jointly with the customer. Transcoject‘s COP syringes and cartridges are compatible with current pharmaceutical rubber formulations of leading manufacturers – also with those made for glass pre-filled syringes. |
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