The principle that Terminal Sterilization provides a higher degree of sterility assurance than aseptic processing is well understood and leads regulatory agencies around the world to require that if a product may be terminally sterilized, it must be.

For the development of the new Getinge GEV TS Series sterilizers we have focused on our customers’ needs and the requirements of the various products to be processed. For the basic GEV TS Series we have focused on life cycle economy, with features for processing most sterile pharmaceutical products, including but not limited to:

• Large volume parenterals in glass or plastic containers
• Vials*, ampoules
• Opthalmic items such as contact lenses in blisters

More delicate items such as:

• Prefilled syringes (in nests or single in bulk)
• Blister packed items may require the additional features of the GEV TS Turbo.

To determine the optimal process conditions for a particular product, Getinge provides testing and process development services in our Customer Application Development Center in Sweden and Sterilization Technology Centers, which are located in Japan, USA and UK. Each center is equipped with a specially designed sterilizer that allows programming of a wide range of process cycles with complete control of all process parameters.

* As previously noted, vials may be processed in a normal vacuum steam sterilizer. However, the load emerges hot and water may be retained under the flip-cap / crimp seal.