A New Concept in Aseptic Filling: Closed-vial Technology
Pharmaceutical Technology Europe in the January 2006 issue published this interesting article by Benoit Verjans, Jacques Thilly and Christian Vandecasserie.
Integral to this “new concept” is using irradiation to sterilize the closed plastic vial prior to filling. In the filling process, a needle penetrates the closed vial through the stopper, injects the liquid into the container, and then, a laser beam reseals the needle hole.
Closed-vial aseptic filling process has these major advantages.
1. Better sterility assurance.
2. Lower level of particle contamination.
3. Major cost and investment savings due to the elimination of several steps, like washing and depyrogenation of the vials, and reduced clean room space.
4. Reduced complexity, with simplified validation and monitoring of this process.
5. The new plastic vial design minimizes breakage and spillage when compared to traditional glass vials.
6. Operator safety is improved, because reduced risk of exposure to potent or cytotoxic drugs.
The authors are forecasting, “Closed-vial technology is likely to become a standard for pharmaceutical aseptic filling processes”.
It is very encouraging to read how radiation- processing technology is being adopted to reduce complexity and costs, as well as improve patient safety. This article can be found at the Pharma Tech Europe website.