WIncM IN War S/o, INE NeXt MEP Is wo CHUTE Ina Ine nasar ron red to the patient is free of microbial contamination, Therefore, it is critical that the evice used for delivering the nasal formulation provides a sterile environment: ve nasal preparation. For unit- and bi-dose formulations, a preservative-free pump #not needed because the formulations are designed fora single use. In some cases, ve conventional pump used for multi-dose Teucaeall hee formulations can be ubjected to gamma radiation to ensure that the pump is free from microbial con- amination, This could be performed before or after the filling process. aon aL 42.1 Ideal Design Characteristics of Preservative-Free Pump devices can : the orifice, the venting ufficient container/dispenser fit wroduce microbial contamination b ir which replaces the dispensed liquid, or due to Brouet and Grosjean 2003). In order to ensure that nasal delivery devices are free of microbial contamination, jis vital that the device can be sterilized before or after the filling process. Therefore, pecific polymeric materials such as high density polyethylene are a good choice for vanufacturing of devices as they resist gamma irradiation and maintain their physi- al properties, For unit-dose and bi-dose devices, creating a preservative-ftee environment for te device is not a major concern since the disposable devices are capable of deliver- 1g one oF two shots can However, for multi-dose devices, the following additional onsiderations apply to ensure that the formulation remains protected inside the ontainer: Pump asa closed system: Metering spray pump should work as a closed system. (full seal system). Unlike conventional metering nasal spray pumps, the closed system does not allow air to enter into the container and come into contact with the nasal drug product, thus preventing contamination from airborne germs. Using a filter: When metering spray pumps are equipped with a filter, the venting air is sucked through a filter assembled inside the , which eliminates the airborne eens and keens them out of the cont: