New generation of isolators for sterility testing

French company Erea has recently introduced the Flux Bulle isolator.

This is in response to the risks of contamination that can lead to correctly manufactured batches being rejected, and to the dangers involved in the manipulation and disposal of sterilisation materials. This new generation of isolators allows the performance of all these tasks to be optimised.

The objectives are to reduce risks and costs while becoming an integral part of production process control flows with a simple, small isolator that is completely empty and ventilated by a vertical laminar airflow. The isolator has smooth inside walls and rounded corners that are easy to clean, and is decontaminated between two tests by simple laminar airflow cleansing (ISO class 5).

The operating principle is simple and uses three 110 mm Bioasafe containers, labelled A, B and C.

Container A, which has two male ports, is supplied empty and sterile. It is connected to the production unit in order to receive the sample flasks or vials to be tested. Using the second port, it is then connected to the isolator (the workstation), to which samples are transferred. When tests are complete, it contains the samples that are to be transferred to an incubator. The container can then be disconnected and sent to the incubator or cut into several small heat-sealed sachets that will protect the samples from any cross contamination.

Container B has a single male port, and is crossed by a flexible tube the end of which is either clamped or taken to an empty recovery pouch. The flexible tube passes through a peristaltic pump, located outside the isolator.

Container C contains all the equipment, materials, and media needed to perform the test. The container and contents are pre-sterilised by irradiation. With standard container, sterilisation is guaranteed for life.

Once tests are complete, equipment and materials simply have to be returned to the container, which is disconnected (and sent to an incinerator if necessary) and the empty work surface is then cleaned. When operations are finished, the completely empty isolator is again ready for use.

This simple unit is easy to transport, and needs no special infrastructure. It can be moved close to production machines to reduce the time taken in transferring samples. With its low costs, practically zero risks and significant time savings (of more than four hours for some operations), the Flux Bulle meets all sterility-testing needs.