First clinical batch made in a disposable isolator

Published: 27-Sep-2017

Solo Containment have supplied an aseptic filling enclosure, enabling the Amatsigroup's Disposable Lab facility in France to produce the worlds’ first clinical batch in a low cost single use flexible film isolator

Conventional aseptic filling line technology is heavily dependent on complex stainless steel isolator technology, requiring a high capital investment and complex infrastructure.

Typically, such systems can take a lengthy period to set up and validate, often rendering small scale vial filling runs, that are for development or cell therapy very costly. Hence, the vision of Disposable Lab to offer a realistically priced fast track alternative technology.

The successful manufacture of a clinical batch in a single use (disposable) isolator is the culmination of a 30 months development between Amatsigroup’s Disposable Lab facility in Bordeaux and Solo Containment in Cheshire.

Disposable Lab already manufacture Pyrofree vials for small scale clinical manufacture and its facility in Bordeaux is the world’s first pharma facility dedicated to the development of single use manufacturing technology.

To advance the single use aseptic filling system vision, the team at Disposable Lab proposed a goal to create a complete “Plug and Play” vial filling system that can be shipped to any global location for rapid manufacture of small scale clinical batches.

Central to this vision was the challenge to develop an isolator to attain a Grade A environment that would be both low in cost and easy to ship and could be set up/validated in hours.

Working with the clinical team in Bordeaux, Solo Containment developed several operational prototypes, which were trialled to prove particle count reduction, ergonomics and functionality to create a single use aseptic fill system.

Differing airflow systems were evaluated before the Solo team developed an innovative method to incorporate large area HEPA filters into a collapsible flexible film work enclosure.

This breakthrough permitted the flexible enclosure and clean air delivery system, fill needles and media fill kits to be condensed down into a very compact volume for terminal sterilisation. The sterilised pack is now ready to be operated and can be shipped to the clinical fill/finish cleanroom in any global location.

The system developed by Solo Containment comprises two principle components; firstly, the pre-filled and sterilised single use flexible enclosure, and secondly an enclosure mounting system and control panel. This matrix contains the special ventilation fan array needed to generate the high volume unidirectional airflow.

Following the success of the early clinical batches created in Bordeaux the Solo Containment team are now advancing the single use isolator design by developing light weight injection moulded air distribution modules, which simply clip into in to the fan array system in minutes permitting the complete aseptic fill/finish chamber to be changed over for a new batch in around 30 minutes.

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