Filling Procedure

________________________________
CONTACT FILLING

Mr. Paaschburg
Tel. +49 4321 885 0
________________________________

PROCESS AND TECHNIQUE

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:

Those tests that we cannot perform on our premises are assigned to certified external laboratories.

ASSURE AN ASEPTIC AREA

Filling

________________________________
CONTACT FILLING:

Mr. Paaschburg
Tel. +49 4321 885 0
________________________________

COMPLEX PROCESSES, MADE-TO_ORDER

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.

Features & Innovations

Luer-Lock respectively a tamper-evident closure with integrated Lock or a customised end piece, any of these affixed by ultrasonic-welding

Clip-on finger plate including backstop

1ml long and 50ml have been developed to a degree that they are just short of readiness for start of production. They are very well suited for individual design adaptations of syringes in order to attain functional and article differentiation.

For example, for cosmetic application, it would be easily feasible to permanently affix sponges or functional elements for the distribution of gels or spray nozzles as Luer extensions.

In a pilot project with further partners, Transcoject has developed a 1ml long staked-needle syringe made of COP that is tungsten-free. In such a staked-needle syringe, the cannula is firmly enclosed by the plastic material, which renders the use of glue unnecessary. Therefore, there cannot be any contact between the agent of the medical drug and glue. In glass syringes, however, such contamination by glue is frequent. The absence of glue in our staked-needle syringe comes as a major advantage, in particular considering the stability of complex molecules, such as proteins.

In a further step, these syringes can be equipped with a needle shield or a tamper-evident closure; they can be delivered in nest and tub and ready to fill.

Syringe Cartrigdes

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.
Transcoject has been offering a 3ml syringe cartridge made from COP which features the needed burst resistance while offering the special properties of COP such as excellent barrier characteristics and optical quality. Where required, syringe cartridges for other volumes can be made short-term and flexibly.

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.