Aseptic filling of sterile drugs remains one of the most challenging processes in biopharmaceutical manufacturing. The increased potency of sterile products requires evaluating the manufacturing process from two different angles: the high containment requirements for the operator and environment safety and the aseptic process regulations for the protection of the integrity for the finished sterile product.
Powder Systems Ltd (PSL) has developed an alternative technology, the dual isolator, to the heavy and complex existing solutions (consisting mainly of integrating an aseptic isolator inside a containment isolator). A dual isolator is a polyvalent containment solution enabling the manufacture of sterile products under aseptic conditions and potent products under high containment operations.
The typical operations that can be carried out within the dual isolator are sterile powder handling, sterile liquid handling, manual filling, microsphere handling and vials crimping.
Design features of the dual isolator include lift-up windows with an inflatable seal for easy access and maintenance, glove-port design for aseptic production, no dead legs, automatic leak rate and temperature monitoring. The dual isolator is mobile and has flexible RTP connections, reduced footprint and remote I/O (integrated into isolator main fabrication). The use of airlock systems to sterilise materials prior to entering the isolator is also available.
All these features make the dual isolator a truly versatile and polyvalent technology, ideal for multi-product manufacturers or CMOs.
Booth 2232, INTERPHEX 2014, 18–20 March 2014, Javits Center in New York City, US.
Powder Systems Ltd, +44 151 448 7700, info@powdersystems.com, www.powdersystems.com.