Current and future developments in pharmaceuticals increasingly rely on aseptic production methods, particularly involving cutting edge gene and cell therapies or in the production of potent or cytotoxic products. Traditional aseptic practices are notoriously slow and unsuited to modern manufacturing. A cutting edge aseptic vial filling solution combines complete containment with maximum throughput, dramatically increasing line efficiency.
The Steriline RVFM Robotic Vial Filling Machine is a highly advanced aseptic filling solution for today’s modern pharmaceuticals. It has been specifically designed for campaign production of high-value products using complete containment technology.
At the heart of the RVFM is an anthropomorphic VHP compatible robot from world-leaders in automation STÄUBLI. The robot handles all vial transport operations within the enclosure.
The RVFM can be specified with a wide range of option to match your requirements exactly. Examples include peristaltic or volumetric piston pump dosing systems, and option to handle single-use disposables. It offers nitrogen flushing before and during stoppering as standard. An additional capping module can be specified to be located on the same monobloc, powered by an additional STÄUBLI robot. This option provides a complete aseptic filling and closing system in one unit.
Quality is assured by means of a 100% IPC or statistical check weighing system placed directly under the filling nozzles, with feedback to the dosing pumps. This allows for an instant refill to target weight for any underfilled vials at point of filling. There is no waste during product path priming. This “zero reject” philosophy is extended to the capper – the RVFM will repeat operations when detecting any missing stoppers or caps, further saving product waste.
With a capacity of up to 6,000 pcs/h, the RVFM can handle vials from 2R to 100H with the highest levels of accuracy and in completely aseptic conditions. RVFM has been engineered not only to meet or exceed all the requirements of cGMP, GAMP and 21CFR Part11, but also to operate with minimal downtime, boosting production efficiency.