Addendum: Functional control of the inactivation process in autoclaves

In the last newsletter, AGCT-Gentechnik-Report 1/2021, we reported on the functional check of autoclaves. The question remains whether and, if so, what a functional check of the inactivation process in the autoclave should be based on if there are no provisions in the official notice. The GenTSV does not contain any detailed specifications on this in its annexes. For the individual safety levels, it only specifies under structural and technical safety measures that an autoclave must be present, where it must be located, and what its design must be. The organizational safety measures also do not contain any further specifications in this regard. There is also no statement from the ZKBS on the functional check of the inactivation process. The LAG-Gentechnik.de website does not contain any further specifications on this. Further specifications for recurring inspections for regular technical inspections of autoclaves as safety-relevant equipment can be found in the Industrial Safety Ordinance (BetrSichV) and, depending on the size, also in the Pressure Vessel Ordinance (DruckbehV). This primarily regulates inspection intervals for technical inspections, responsibilities, and the qualifications of qualified personnel. A functional check to determine whether a technically flawless autoclave actually functions is also not provided for. For safety level 1, the technical inspections are generally considered sufficient (see "Genetic Engineering Facilities - Technical Requirements - Environmental Technology Coordination Office of the State of Lower Saxony," p. 71). From S2 onwards, faith in the functionality of the technology is lost. The same document then recommends verifying the success of the autoclaving process twice a year using biological indicators. There is no legal requirement for this. Furthermore, it is not possible to directly refer to DIN EN ISO 11138-3:2017-07 for the state of the art, as this standard only applies to the sterilization of healthcare products - biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2017) and is therefore not designed for an autoclave in a genetic laboratory. Accordingly, if the approvals for the facility/work do not provide for a functional check of the autoclave (which would then have been subject to legal recourse), no further check of the functionality of the autoclave is legally required beyond the technical check of the autoclave. From March 1, 2021, according to Section 17 (6) of the GenTSV (2019), in general, i.e. also in S1 facilities, in addition to the functionality, the effectiveness of safety-relevant devices or facilities, such as autoclaves and safety cabinets in particular, must be regularly checked according to the state of the art in science and technology, and the result and date of the effectiveness test must be documented.