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:

• bioburden
• osmolality
• viscosity
• proportion of decisive ingredients
• pH value
• endotoxins

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

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.