My Terragene’ November Tith, 2021 To whom it may concern We, TERRAGENE S.A, located in Alvear, Santa Fe, Argentina, hereby declare that the following specifications apply for IG/OG/PQ Process validation schemes for Terragene Bionova” IC10/20FR Auto-readers. Installation qualification (IQ) specifications 1Q Spe Terragene does no specify any special requirements for the installation of Bionova* IC10/20FR Auto-readers. The installation and start-up of the Auto-reader is carried out by the user by following the steps detailed on the user manual. ations applicable for the device: NO. Operational qualification (OQ) specifications 04 Specifications applicable for the device: NO Bionova® IC10/20FR Auto-reader performs automated internal tests to verify that the device is working according specifications. If the tests reveal that the device cannot perform its intended use correctly, the device will not allow the user to proceed with an incubation, either by canceling a single incubation position or by canceling the possibility to perform incubations on the device altogether. Such findings are informed to the user by an audible & visual alarm and a printed ticket. Performance qualification (PQ) specifications PQ Specifications applicable for the device: NO Bionova* ICIO/20FR Auto-reader performs automated internal tests to verify that the intended use of the device can be correctly carried cut at any moment. The automated tests verify that both the readout system and the incubation temperature are according to specifications. Also, the use of positive control indicators is recommended on the Auto-reader’s User manual. A positive control is anon- sterilized SCBI used as a reference during the incubation process. The use of a positive control is a recommended practice as it helps to ensure: + The correct incubation temperature is reached. + Viability of spores has not been altered due to improper storage temperature, humidity, or proximity to chemicals. + The aptitude of the media to promote rapid growth and fiuorescence generation. + Proper functioning of the incubator. Please refer to the Auto-reader User manual and to the Biological Indicator instructions for use for more information, Ruta Nac. N? 9, Km 280, CP 2130, Parque Industrial Micropi, Alvear, Santa Fe, Argentina Tel +54 341 5587007 - info@terragene.com - www.terragene.com