The formulation filling process typically involves the preparation of semi-finished products, room-to-room transfer, terminal sterilizing filtration, and aseptic filling. A single-use aseptic filling system is a pre-validated, pre-assembled, and pre-sterilized aseptic transfer production unit, including disposable liquid storage systems, wall-through systems, sterilizing filtration and receiving bags, filling bags, filling tubing, and single-use filling needles.
In addition, the production environment of the single-use aseptic filling system needs to match the application requirements. For instance, the production of the buffer bags in filling machines should be in a Class 100 (ISO 5, Class A) environment. Additionally, it must comply with the general regulatory requirements for single-use systems, such as particulate matter control, E&L evaluation, bacterial endotoxins, and sterility.
The design of single-use filling systems for different backgrounds of biopharmaceutical filling environments, such as laminar flow, O-RABS, C-RABS, isolators, varies significantly. Considerations include:
1.Filling bag’s design form, hanging position, and connect method with the front-end receiving bag.
2.Aseptic transfer method of filling bags.
3.Matching of filling pumps and installation of filling needles.
4.The overall impact of the entire single-use system on the actual filling production process, including filling accuracy, range of filling volumes, and filling time.
5.Selection and integrity testing of filters, as well as environmental impact control by the system.
Furthermore, the Cobetter single-use technology team can assist pharmaceutical companies in verifying and defining the filling accuracy and optimal recommended service life of filling tubes under worst-case conditions for different filling volume ranges and process times. This ensures the reasonable and stable use of single-use filling systems.
Cobetter's single-use aseptic filling system has been successfully adapted to common filling machine brands such as Bosch and Romaco, and is suitable for vials, ampoules, pre-filled syringes, and other forms to meet the filling requirements of 1-12 needles. It can avoid the risk assessment of co-line and cumbersome cleaning validation, thereby enhancing the level of personnel protection for highly toxic and active products.