Automated Filling and Capping Systems Take Centre Stage

A notable bio-therapeutic products manufacturer is using two high specification automatic aseptic filling and plugging systems supplied by Watson-Marlow Flexicon, at its brand new clinical trials facility in the UK. The FPC50 systems, one of which is subjected to virus-based products, are housed in isolator units built by Huddersfield-based Extract Technology Ltd, a specialist manufacturer of aseptic isolators.

The company’s FPC50 automated vial filler and capping unit is a compact system that offers a number of advantages including: no cleaning validation; easy product changeover; no cross contamination; and high accuracy peristaltic filling better than ±1% for filling volumes ranging from 0.1ml to 100ml, ensuring substantial annual savings. The unit can fill up to 25 vials per minute and is designed purposely to integrate into an LAF cabinet or an isolator.

The peristaltic filling system on the FPC50 not only avoids the problems of cross contamination, it also eliminates the costs and difficulties of having product and volumededicated volumetric filling pumps in stock. With the entire fluid path designed for single use, all historical documentation related to volumetric pumps is unnecessary, making cleaning validation extremely simple.

Both systems deploy rapid transfer port (RTP) entry. Following completion of the transfer process, the equipment is placed upon storage racks and hanging rails prior to the commencement of the automatic sanitisation phase.

The two isolators vary only at the exit stage. Exit from the virus fill system differs in that capped vials are accumulated within product transfer trays before being transferred from the isolator through a Bioquell Clarus PORT (rapid gassing) and transferred to an adjacent process area. Each tray is placed on a rack within the Clarus PORT before being subjected to a rapid decontamination cycle.