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:
- proportion of decisive ingredients
- pH value
Those tests that we cannot perform on our premises are assigned to certified external laboratories.