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Incomina time: (April to October rat required) <br />Preeonditio0 req <br />Dwell: <br />MPI MEDICOPLAST <br />Sterilization certified in <br />fine with <br />EN ISO 13485:2016! EN ISO 11135:2014 <br />35.46-C 6040%rel.humidity <br />Confirmation of Sterilization <br />Method: VA -S_1 <br />Sterilization date: <br />2021-06-20 — <br />Sterilization lot <br />19001 <br />Customer. <br />MT.DERM GmbH <br />Your requisition no.: <br />16062021 <br />130 mbar abs <br />G813=21-EB1677 GB4=21-EB1678 G81=21-EB1679 <br />50.80%rel.humidity <br />GB27=21-EB1680G823=21-EB1681 GB2D=21-EB1682 <br />EO mass <br />GB7=21-E81683 GB19=21-EB1684 GB6=21-EB1665 <br />3 h <br />25 kg <br />GB16=21-EB1686 <br />Our delivery note: <br />255977 from 2021-06.24 <br />Item: <br />9900031 <br />Stenftation Pal. MP01 td NK <br />min 1 Days <br />Pr70 <br />OcarW. <br />10 Pal. <br />3545 °C <br />Nominal values Actual values <br />Incomina time: (April to October rat required) <br />Preeonditio0 req <br />Dwell: <br />min 16 h <br />24,5 h <br />Cond'Nors: <br />3545`C 50-t30%relhuanidity <br />35.46-C 6040%rel.humidity <br />Sterilization <br />Cycle. <br />M.1 <br />Temperature: <br />40 33 °C <br />41,6 °c <br />Pre`racum: <br />120f10mbarabs <br />130 mbar abs <br />Humidity. <br />Dwell line: <br />50.80%rel.humidity <br />73,5% rel.humidity <br />EO mass <br />3 h <br />16-32 kg <br />3 h <br />25 kg <br />Air washes: <br />min 3 <br />3 <br />ration <br />Dwelt <br />min 1 Days <br />3,5 Days <br />Conditiort <br />3545'C <br />3545 °C <br />Remarks: <br />The evaluation from the BI's is in process. <br />The physical parameters were in accordance to the specifications. <br />No growth was observed for the microbiological inprocess control with biological <br />indicators (Bacillus atrophaeus, 3M Attest). <br />The sterilization was conducted in line with the customer validation parameter. <br />Approval <br />Signature OS: Date: 0 <br />20.06.21 CHARGEN-NR.: 19001 <br />11:41:57 GERA.TE-NR. 1895 <br />BEDZENER 2 <br />PROGRAMM-NR: 70 <br />ANF.-DRUCK 600 <br />END-DRUCK 500 <br />TEMPERATUR 40 <br />0 0' is, 30' . 45' <br />P <br />i r;--- <br />rl <br />r:/rte <br />r3/4fi <br />r4J4B <br />45/112 <br />HIM <br />105' <br />FREIGABE <br />2 9. JUNI 2021 <br />�YoOaLu� <br />FREIGASE <br />2 9. JUNI pipp <br />