Properties of autoclaves in the genetic laboratory

It is crucial to observe the different requirements for the safety levels and to start the corresponding procedures for notification, registration, or approval in a timely manner, depending on the safety level. Which autoclave is used for which safety level? Relevant here is the autoclave for the inactivation of GMOs – i.e., waste disposal. In an S1 facility, it is sufficient if the autoclave is located within the company premises. However, it is crucial that the transport of GMOs there, if necessary, takes place in shatter-proof, sealable, and disinfectable transport containers. You can find the relevant requirements in GenTSV Appendix III (Safety Measures for Laboratory and Production Areas). You can also read the facility's notification of how this has been applied for and approved in your facility. As of commissioning, the licensing authority must be informed of the location of the autoclave for inactivation and how the transport route for the GMOs is ensured. For S2 and higher facilities, the autoclave must ideally be located in the laboratory or at least be accessible within the building. The exhaust air from the autoclave must be purified by filtration or thermal treatment. In an S3 facility, the autoclave must be located within the laboratory. Transport to another laboratory is strictly prohibited. In an S4 facility, the laboratory must be equipped with a pass-through autoclave, whereby the resulting condensate must be additionally sterilized before being discharged into the wastewater. In existing facilities, it occasionally happens that the autoclave must be replaced with a newer model. Before purchasing, it is important to carefully check whether the autoclave meets the relevant requirements. Then it is purchased, and all colleagues are relieved that this project has been completed. At this point, it is often forgotten to notify the authorities of the new purchase. What does this mean in practical terms? Since the autoclave is a safety-relevant device in the genetic engineering facility, and in this context, this involves the procurement of the genetic engineering facility, Sections 8 et seq. of the GenTG (German Genetic Engineering Act) apply. If it is an S1 facility, the licensing authority must be notified. Within an S2 facility, registration is required. A permit is required for S3 and S4. The current forms for the respective procedures can be found on the website of the Federal/State Working Group on Genetic Engineering (LAG, https://www.lag-gentechnik.de/Fuer-Antragsteller.html ). The relevant deadlines for notification, registration, and approval procedures (Section 10 of the GenTG) also apply here. At this point, it becomes clear that retrospective notification is not sufficient; the corresponding procedure must be initiated in advance.