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Veterinary multi dose injectables maintenance of sterility and container integrity



Veterinary multi dose injectables maintenance of sterility and container integrity



Drug Development and Industrial Pharmacy 4(5): 447-462



Antimicrobial preservative effectiveness, resealability and needle mediated rubber particle generation tests were used to determine the ability of a parenteral multidose-formulation-container system to maintain product sterility and container integrity throughout its expected life cycle. Methods and recommendations with regard to preservative concentrations, vial sizes, closures, needle gauges and the number of entries allowable into the container are detailed.

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Accession: 006903480

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