Research report Updated GMO Containment Risk Evaluation Of Single-Use Bioreactors

On a regular base, the COGEM advises on the large-scale manufacturing of genetically modified organisms (GMOs) in Single-Use Bioreactor (SUB) systems. These SUBs consist of a plastic disposable bag provided with all the necessary ports and mounted in a re-usable stainless steel vessel. The major advantage of these systems is their disposable nature, not requiring any cleaning sterilisation and validation after use.  At the other hand there are several points of attention for manufacturing SUBs, like the chance of leakage of these bags resulting in the release of GMOs into the environment.
Over the past years, the use of SUBs has increased considerably and this has resulted in an increase in knowledge and experience by manufacturers as well as end-users. Therefore, the COGEM commissioned a follow-up investigation on the current state of practical experiences with respect to the containment of GMOs.
The resulting report shows that producers and end-users have developed special training courses for personnel using SUBs. Besides, in practice the ‘medium hold test’ is used for testing the integrity of the SUB because the ‘pressure hold test’ has several disadvantages. This in line with the advices on SUBs COGEM has issued until now.
The investigators point out that this ‘medium hold test’ is not able to detect pin hole defects above the fluid surface. COGEM notes that in The Netherlands activities with SUBs are performed at containment level ‘MI-III’, which provides additional containment conditions and minimalizes the chance on spread of GMOs. COGEM points out that personnel handling SUBs has to be aware of the possible presence of pin holes.

The accompanying letter explaining the opinion of COGEM is only available in Dutch.