Functional control of the inactivation process in autoclaves

In principle, the operator of a genetic engineering facility must ensure that genetically modified material in waste and wastewater is pretreated before leaving the genetic engineering facility in such a way that it poses no danger (Section 23 (1) GenTSV 2019). Appropriate evidence of inactivation kinetics must be provided. In most cases, an autoclave is used for inactivation in genetic engineering facilities. If this uses the fractional pre-vacuum process, it can be assumed that the inactivation requirements are met with the corresponding programs. Nevertheless, there is an obligation to provide evidence, which is usually specified in more detail in the notices relating to the genetic engineering facilities. The respective requirements for the genetic engineering facility can be found in the ancillary provisions under "Inactivation as part of wastewater and waste treatment." This stipulates the intervals at which an effectiveness check must be carried out. Reference is made to the state of the art. Bioindicators are specified for this check (DIN/EN ISO 11138-3). The test organism Geobacillus stearothermophilus is normally used, which is inactivated during a successful autoclaving process, as evidenced by subsequent incubation. Appropriate bioindicators can be purchased commercially. The implementation and results of the test, as specified in the genetic engineering facility's approval, are subject to mandatory documentation. If the functional test does not demonstrate the required success, the autoclave must not be used for further inactivation processes until the error that led to the failure must be rectified. Only after the error has been rectified and another successful autoclaving test has been performed can the autoclave be used again to inactivate waste and wastewater. In this way, the operator of a genetic engineering facility fulfills its obligation to ensure the successful inactivation of genetically contaminated wastewater and waste.