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Ompi EZ-fill is the ready to use solution that provides clean, sterile, depyrogenated glass containers: syringes, vials, cartridges. At CPhI Madrid Ompi will present its brand new in house steam sterilization process for vials and cartridges. Andrea Zambon, Product Manager EZ-fill Vials & Cartridges, will go in the details of this new solution during the presentation “EZ-fill Nest&Tub glass containers: EtO or Steam sterilized options" at the Exhibitor Showcases - Speaker’s Corner (InnoPack 4F70), 3.30pm on October 14th.
“The sterilization is one of the most critical part in the production of ready to fill glass containers and it is nowadays applied by ready to fill glass containers manufacturers mainly through Etylene Oxide (EtO). This method has served the market well for many years, but as drugs and delivery devices have advanced, some limitations have become apparent” said Andrea Zambon, Product Manager EZ-fill Vials & Cartridges, “the rapid rise in biological drug development is expanding the market for new sterilization technologies that can overcome the limitations of current method and facilitate innovation and progress in the pharmaceutical and biotechnology industries.”
A highly regulated topic
Even though EtO sterilization is largely validated and used in the market, according to US/EU Pharmacopeia guidelines and Good Manufacturing Practices (GMP) guidelines it should only be used when no other method is practicable. This is in order to ensure that any residue of gas or its degradation products in the sterilized product is below the concentration that could give rise to toxic effects during the use of the product. EtO sterilization is frequently made when the material to be sterilized cannot withstand the high temperatures obtained in the steam sterilization.
The best solution for sensitive biotech drugs
The need of having an alternative sterilization method in addition to EtO is even more and more necessary if we look at the rapid rise in biological drug development, where a lot of instable molecules and biotech drugs that can react with the primary containers are under development. Due to its structure, EtO is counted among the very reactive compounds: having a new way of approaching drug/container interaction especially for biotech drugs is now a must to have and not a nice to have.
Steam sterilization in Ompi
Steam sterilization in Ompi is actually performed in an autoclave by a specific and well-designed cycle that is today the earned result of a long study on all its critical parameters and their interconnections.
Ompi is going to introduce starting from October 2015 the first validated formats of Ompi EZ-fill Vials with steam sterilization (from 2R to 8R) that are going to be added to the pre-capped cartridges already offered on the market with this kind of sterilization. Its aim is to widen its steam-sterilized portfolio in the following months.