Innovation in the sterilisation of pharmaceutical vials
A Belgian company has developed a process for filling bottles without opening them. This is a key benefit for the biopharmaceutical sector to avoid the possible bacteriological contamination of its medicines.
In the biopharmaceutical environment, a single small bacterium during the filling of a vial can subsequently multiply and create serious risks of causing septic shock in the patient who receives the product. Similarly, the accidental introduction of non-living particles such as dust or small aggregates can also lead to the destruction of entire clinical batches. The importance of a completely sterile environment is therefore a determining issue, especially for new biological drugs such as monoclonal antibodies.
Aseptic Technologies has identified this crucial issue for new and rapidly expanding gene and cell therapies and has developed revolutionary equipment for the manufacturing and bottling of these new biotechnology drugs. However, the concept is simple and involves a special needle with a very particular shape that has been patented by the Namur-based company. This needle pierces the stopper of the vial that has already been closed and completely sterilised. When the needle comes out, its specific shape leaves only a tiny hole in the stopper, which is then re-welded with a laser and covered with a capsule.
Aseptic Technologies supplies these types of filling machines with closed vials to a growing number of customers such as research centres, biotechnology companies and pharmaceutical laboratories.