Microbiological stability tests with simulated broth preparations and integrity testing for sterile standard cytotoxic preparations

Abstract

The objectives were to assess the microbiological stability and the physical enclosure integrity of the overwrapping for batch production of standard cytotoxic injectable solutions.

Keywords

• batch production
• cytotoxic drugs
• dye penetration test
• microbiological stability
• overwrapping
• physical integrity test
• rapid microbiological methods
• sterility test