Betzy,
Reusable autoinjectors are NOT required to be sterile or sterilized. Disposable autoinjectors, which are provided with the drug (usually a Prefilled syringe) are also not required to be sterile except that the syringe or self-contained primary container closure must maintain the sterility of the injectable solution. The only exception is where the design of the disposable autoinjector is such that the injector contains part of the fluid path that contacts the drug. These designs usually use cartridges instead of Prefilled syringes that are punctured by a needle in the injector, which must of course be sterile..
Lee Leichter
President
P/L Biomedical
10882 Stonington Avenue
Fort Myers, FL 33913 USA
O: +1-239-244-1448
F: +1-815-550-0162
C: +1-239-994-6488
E: leichter@plbiomedical.com