Bioluz offers its customers filling services for small series bags in aseptic filling.
Aseptic filling is the required technique when terminal sterilization is not possible.
This technique is complex. The material used is different, it is PP or EVA (ethyl vinyl acetate) which can be sterilized by irradiation before filling.
The difficulty of this type of process can increase, depending on the type of preparation, there are two situations:
- the preparation can be sterilized by filtration through 0.22µm filters,
- The preparation can’t be sterilized by filtration and must be prepared aseptically
In the first case, we can carry out the filling aseptically by sterilizing filtration. In the second case (suspension, emulsion, high viscosity solution) we can work from sterile solution delivered by the customer. This will be filled aseptically under an isolator. In both cases we can perform the fill and finish. These techniques are necessary for thermolabile solutions (most of culture media used in biotechnology)
The validation of this process will be carried out in accordance with Annex 1 of the GMP in force with 0.22 µm double filtration as well as by simulating all the stages of the manufacturing process with culture medium.
It can be interesting to add techniques to reduce the bioburden such as pasteurization or hyperbaric sterilization. This has a some activity against mycoplasmas. These are an endemic problem in cell culture processes. Hyperbaric technology makes can decrease the initial population.
These sterilization methods are useful for limiting the bioburden before filtration and can be used in certain processes.
The possibility of combining different techniques for reducing the bioburden with sterilizing filtration makes it possible to meet the majority of the increasingly complex requests of our clients.