Nitrogen Dioxide Biodecontamination

The prefilled syringe marketcontinues to grow. In the past, products that are not candidates for oral administration(likelarge molecule compounds)would be delivered in a multi-dose vialcontainer. Today, many of these productsare administered inprefilled syringes to reduce the risk of injury to health care workers administering the drug, to reduce thecontainer overfilling, and to improve dosing accuracy(Daedal Research, 2013).

Tomeet the growing demand,companies install small, medium and high-speed filling lines, depending on production needs. The majority of filling lines installed each year are small to medium speed lines, filling100to 200 syringes per minute, orabout 1 to 2 syringe tubs per minute (Lysfjord, et al., 2010).These filling lines are used for commercial product, clinical trial or pre-clinicalproducts. High-speed filling lines aretypically reservedfor large volume products, where the filling lines can fill syringes at a rate of six tubs per minute.

These filling lines rely on sterile, clean and ready-to-fill syringes that are packaged in tubs. Glass or polymer syringes are manufactured and placed inthese(polystyrene) tubs for shipping. Typically, there are 100 syringes in a tub. These tubs are sealed with a Tyvek lid, forming a sterile barrier. Once the lid isapplied, the tub is placed in an outer bag for additional protection,then placed in a carton. The syringes packaged in cartons are sterilized via ethylene oxide or gamma radiation and shipped to the site for filling.