Physical data of the DPTE® system with assurance of microbial quality
5 October 2012D. Meyer GETINGE
The residuals of injectable anti-cancer drugs represent both an economical and an ecological challenge. Economical, as often expensive, a maximum quantity must be used from each vial. Ecological, as often toxic, they must not pollute the environment.
Within the use of an air tight and sterile isolator they can be transferred, stored and wasted in conditions which must on a long term basis keep the air tightness to protect environment and operators and to preserve the sterility. This is the reason of the use of DPTE® containers.
This short slide set will show:
- Principe of DPTE® system
- Air tightness values according to ISO 10648-2
- Air tightness control with pressure differential
- Air tightness test with non viable particulates
- Microbial air tightness test with Bacillus subtilis thermophilus
- Long term sterile testing of DPTE® Beta container and its containing with TSB
As a conclusion, we can say that the reproducible physical figures of the DPTE® transfer system allow the use of its dedicated containers for validated air tight sterile transfer and storage of residuals of injectable toxic drugs.