Automated filling and capping systems for clinical trial facility

1st April 2013

AUK-based bio-therapeutic products manufacturer is using two high specification automatic aseptic filling and plugging systems at its brand new clinical trials facility. Supplied by Watson-Marlow Flexicon, the FPC50 systems, one of which is subjected to virus-based products, are housed in isolator units built by based Extract Technology, a specialist manufacturer of aseptic isolators. Extract Technology was introduced to the project by Bioquell UK of Andover, a provider of hydrogen peroxide vapour (HPV) bio-decontamination solutions, which interfaced its own Clarus L HPV generator with both isolators. The Clarus L completes an automated high level disinfection process to achieve six-log sporicidal reduction on all surfaces within the isolator. This is achieved by depositing a fine layer of hydrogen peroxide condensation during the decontamination phase which is then evaporated in the aeration phase providing a residue-free process with excellent material compatibility - including sensitive electronics.

Watson-Marlow Flexicon has specialised in aseptic peristaltic filling and capping systems for pharmaceutical, biotech and diagnostic applications for nearly 25 years. The company's FPC50 automated vial filler and capping unit is a compact system that offers a number of advantages that include: no cleaning validation; easy product changeover; no cross contamination; and high accuracy peristaltic filling better than +/-1 per cent for filling volumes ranging from 0.1ml to 100ml, ensuring substantial annual savings (Fig.1). The unit can fill up to 25 vials per minute and is designed purposely to integrate into an LAF cabinet or an isolator.

Neil Cocker, technical manager at Extract Technology, says: "In the past couple of years we've diversified into the manufacture of aseptic-type isolators that protect the product from the operators and surrounding environment. Whilst these were our first filling line isolators we utilised our experience of integrating process machines into isolators and developed a close working relationship with Watson-Marlow Flexicon to enable the project to be very well executed.'

The main operating functions of the systems specified by the customer for its new clinical trials facility included:

- The provision of a controlled, aseptic environment in which a vial filling machine, weigh scale, capper and associated ancillary devices could be installed.

- The protection of the product and sterile processes while loading the isolator enclosure with equipment and product/components to be processed; the protection of the product and sterile processes while manually preparing the product batch - and when filling, stoppering, check-weighing and capping the vials.

- The provision of a controlled means of removing processed product and waste materials from the isolator enclosure.

- The protection of the operator and local environment while decontaminating the isolator enclosure.

The aseptic filling isolator has a purpose-designed layout to suit the vial trays, product transfer interface and means of aseptically transferring product/equipment into or out of the chamber via a rapid transfer port - with continuous liner bag-out of filled vials in trays. In addition the filling machine is free-standing with a false floor created in the isolator at bed plate level (Fig.2). Generally speaking the two isolators are identical with variation only at filled vial exit. As one of the systems is exposed to virus-based products, this isolator has a Bioquell Clarus PORT (rapid gassing) for decontamination of the outside of filled vials in open trays.

Such clinical/sterile environments are a common application for the peristaltic technology offered by Watson-Marlow Flexicon. The peristaltic filling system on the FPC50 not only avoids the problems of cross-contamination, it eliminates the costs and difficulties of having product and volume-dedicated 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.

The FPC50 units used for this particular application feature a total of six 240 x 240 x 30mm trays accommodating 10ml glass vials filled with bio-therapeutic liquids. The actual process consists of three stages defined as entry, processing and exit.

Both systems deploy rapid transfer port (RTP) entry, whereby all of the necessary equipment is transferred into the isolator via a 350mm rapid transfer port mounted to the left hand sidewall of the chamber. 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.

"Once this is complete, the vials and rubber stoppers are loaded on to the Watson-Marlow Flexicon FPC50 filling machine where processing begins," says Cocker. "Accumulated filled vials are removed manually from the filling machine with the vials being check-weighed before being manually capped and removed from the isolator."

The two isolators vary only at the exit stage. For the aseptic fill system, capped vials are accumulated within product transfer trays which are sealed before being transferred from the isolator via the continuous liner bag-out system. Each tray is placed in the continuous liner prior to the liner being heat sealed and cut, with the process repeated until all of the filled vials have departed the isolator.

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.




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