1. Field of the Invention
The present invention inter alia relates to a method for producing of a single-use cell culture container.
2. Description of the Related Art
Such cell culture containers are well known in the art and are at least partially made from polymer material. The known cell culture containers may be constructed from multiple layers, wherein the inner layer, i.e. the layer which gets into contact with the cell cultures, is made of a polymer material. Usually at least this layer consists of polyethylene (PE) or ethyl-vinyl acetate (EVA).
A single-use cell culture container is a container which may be used for the biopharmaceutical or other production of peptides, proteins, antibodies or other bacterial, microbiological or cellular products in large amounts. Said process is also named fermentation and so-called bioreactors are used for this fermentation process. In the context of the described invention a single-use cell culture container, which is usually formed of a polymer material in the form of a bag for producing large amounts of biological materials, may also be called a disposable bioreactor. In the following text the term cell culture container means any shape of a single-use cell culture container or disposable cell culture container or bag or bioreactor for the production of biomaterials.
Before filling the known cell culture containers, which are in particular present in the form of cell culture bags, these containers are treated with gamma radiation for sterilization. This treatment is required in order to kill all microorganisms, which may disturb or affect an optimal cell growth. The sterilization is usually done such that a plurality of cell culture containers is introduced into a radiation device. Subsequently, the cell culture containers are treated with gamma radiation.