Microbial integrity test for preservative-free multidose eyedroppers or nasal spray pumps

Rubrik: Originale

(Treffer aus pharmind, Nr. 09, Seite 1247 (2019))

Marx D | Bartsch T | Wohnhas R | Zwisler W

Microbial integrity test for preservative-free multidose eyedroppers or nasal spray pumps / Marx et al. • Microbial integrity · Marx D, Bartsch T, Wohnhas R, Zwisler W · ¹Aptar Radolfzell GmbH, Radolfzell und Labor Dr. Merk & Kollegen GmbH, Ochsenhausen und Zwisler Laboratorium GmbH, Konstanz
microbial integrity testing preservative-free multidose systems eyedropper microbial contamination Preservative-free multi dose dispensers are now well established on the market, e.g., for nasal spray or eye drop products. The technology behind such container closures systems ensures that the container content remains sterile during storage within shelf life and the in use period which lasts often at least for 28 days. For historically used standard multidose devices, the sterility of the formulation had to be maintained by the added preservatives, in most cases benzalkonium chloride (BAC). The diverse preservative-free technologies which make the use of preservatives obsolete (e.g., tip seal or ...