In February, the Pharmapack Europe Exhibition brought together the pharmaceutical packaging and drug delivery system industries over two days in Paris, at Porte de Versailles. This year, ARaymondlife* had decided to create a buzz around its innovative capping solution for aseptic filling, RayDyLyo, under isolator in partnership with Disposable Lab.
The Pharmapack Europe Exhibition took place on 10 and 11 February in Paris, at Porte de Versailles. Dedicated to packaging innovations and drug delivery technologies, Pharmapack is an essential event in the health industry.
It was a chance to promote RayDyLyo, one of ARaymondlife's flagship products. RayDyLyo is an innovative, ready-to-use, fully plastic capping solution. RayDyLyo can be used for injectables for both liquid and lyophilised forms, and is available in 13 mm and 20 mm diameters. The pre-assembly of the stopper in RayDyLyo allows a tight seal of the vial in a single operation. RayDyLyo can be used in closed systems, isolators or RABS, for manual or automatic closure of ISO vials. It is also suitable for automated closure of vials in nests.
This year, ARaymondlife decided to welcome Disposable Lab (an independent French company specialising in single-use production equipment), to its stand, in order to offer a global solution for aseptic filling under isolator. "At Pharmapack Europe in previous years, we presented the RayDyLyo product, and today we are presenting a solution in real conditions of use." explained Stéphanie Pellet, head of marketing at ARaymondlife.
At the stand, the demonstration attracted many visitors: an operator filled the vials with a pipette in a single-use isolator. Once filled, the vials were closed manually with RayDyLyo integrating a stopper, all presented on a strip containing 10 RayDyLyos: the demonstrator does not need to crimp the vials and they can be closed with simple downward pressure. RayDyLyo's strip packaging process means that 1 to 10 vials can be closed simultaneously after filling. "This demonstration illustrates the combined solution that we are offering with ARaymondlife," explained Jacques Decœur, president of Disposable Lab. "Thanks to the single-use isolator, to our Pyrofree technology and to the RayDyLyo capping solution, the vials are closed in a perfectly sterile environment."
The Pyrofree® technology can be summarised as follows: the washed and dried vials are placed in a double PEEK bag. They then go into a vacuum, then a furnace, in order to sterilise and depyrogenate them. Finally, the bag is removed from the furnace before being packaged in an overpack. "Pyrofree® bags can hold almost 250 x 2 ml vials or 63 x 20 ml vials" states Jacques Decœur. Before entering the distribution chamber, the overpack will be taken off, the external layer of the double bag decontaminated and the internal layer removed. The vials which arrive in the isolator are therefore sterile, depyrogenated and ready to use in aseptic filling. After capping with RayDyLyo, the vials pass through an evacuation shaft.
The single-use isolator, an example which was demonstrated on the stand, allows 1,000 to 1,500 vials to be filled per day, in a certified sterile environment which can be reproduced at industrial level. With RayDyLyo, this environmental integrity is maintained because the RayDyLyo ready-to-use solution eliminates the critical crimping step and the potential risks of particulate contaminations.
"We chose to partner with Disposable Lab, because the synergy between our two respective solutions seemed obvious," explained Philippe Daurenjou, commercial director for ARaymondlife. "They had a solution for sterilizing and depyrogenating the vials, and they needed a simple capping solution for those vials, which we provide with RayDyLyo," Jacques Decœur added: "To obtain a good level of sterility, heavy investment is usually required by companies who don't necessarily have the means, not to mention the costs of cleaning. With our solution, everything is disposable. Thanks to this marriage of expertise, we are offering a complete, rapid, simple and economical service, to optimise the production of technical batches, clinical batches or feasibility batches. This in itself might interest the Research and Development departments of pharmaceutical laboratories, for the production of their clinical batches."
This combination of ready-to-use solutions revolutionizes the traditional process for filling and closing vials. "Joint seminars are planned all around France, to present our combined offer of RayDyLyo, Pyrofree® and Disposable Lab's single-use isolator to biotechnology companies," said Philippe Daurenjou. "And Pharmapack 2017 is already on the schedule!"