New B Innovation Limited (New ß Innovation) uses a partially automated aseptic filling and sealing line for pre-sterilized infusion bags.
Frequently, after being filled with liquid, infusion bags are terminally sterilized to ensure the vitally important sterility. However, this method is not suitable for active ingredients that are sensitive to heat or gamma radiation, as is the case with the products of the Hong Kong biotechnology company New β Innovation. The company is specialized on veterinary products and operates in the world market for medical biotechnology.
However, this method is not suitable for active ingredients that are sensitive to heat or gamma radiation, as is the case with the products of New β Innovation. That’s why Harro Höfliger went in a different direction with its first aseptic filling and sealing machine for IV bags. Our experts focused on completely sterile processes and an active open restricted access barrier system (RABS).
“One-time docking”: a global first
The machine is loaded manually. Operators use glove ports to open the pre-sterilized, bagged components, as well as to separate them. A camera records the position of the bag on the transfer belt so that the Stäubli Stericlean robotic arms can precisely place the IV bags on the rotary platform and connect the filling tube to the aseptic triple filling head.
The special feature is that the connection to the filling nozzle remains in place through all of the following gas purging, evacuation and filling processes until the transfer from the machine. Harro Höfliger uses this one-time docking principle to minimize the risk of particle entry and keep the residual oxygen content in the bag low.
The amount of nitrogen flushing and the subsequent evacuation of the bag using vacuum can be flexibly adjusted. An integrated, laser-based Wilco HSA (head space analysis) module provides an in-line measurement of the oxygen content, making the quality control results available immediately.
If the residual oxygen level is over one percent, the bag is removed and not filled. A high-precision measurement of mass flow using the Coriolis effect is performed by a sensor, which ensures that each infusion bag has been filled to exactly the right amount. An aseptic rotary distribution is used to supply all fill media in a sterile manner.
The opening is tightly sealed by radio frequency welding to minimize the heat transfer to the active substance. Then, the filling tube is cut off and removed. An important component of quality-oriented production is perfect cleaning after each batch using an integrated CIP/SIP (cleaning in place/sterilization in place) system.
Benjamin Wai, Director of New B Innovation Limited, is impressed by the final product: “The filling system is one of a kind, only the team at Harro Höfliger can make it happen.”