Use of isolators as part of the future technology in the hospital pharmacies in Denmark ?
8 September 2021T. Schnor (Herlev, Denmark)
We expect that the isolator technology will become more and more widespread in the Danish hospital pharmacies over the next years
Isolator technology can be used in various types of production at hospital pharmacies in Denmark.
Large scale aseptic production
In order to meet the new requirements in the coming “New Annex 1”, it can be advantageous to invest in isolator technology, especially for large scale aseptic production. This technology will reduce costs for upgrading of the existing facility as well as reduce the ongoing costs for hygiene monitoring, clean room clothing, etc. For this type of production, the production line will consist of several modules of isolators.
Small scale aseptic production
This can be both batch production from API and reconstitution. For reconstitution where a longer shelf life than 24 hours is wanted, it is advantageous to use isolator technology. At the same time it will increase the quality and reduce the costs.
Can be used for reconstitution of GMO products. The isolator tent must be discarded after use for protection of the environment as well as a safer work environment. This type of isolator has been used in Denmark for the preparation of Luxturna and Zolgensma. For these products the isolator was approved by the Danish Working Environment Authority
The single-use insulator can also be used for the preparation of non-sterile drugs containing toxic API. A disadvantage of using the single-use isolator is the cost of the tent of 2,700 euro per tent