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I <br />Sterilizationcertified inline with MPI MEDICOPLAST <br />EN ISO 13485:20161 EN ISO 11135:2014 <br />Confirmation of Sterilization <br />Method: VA 5 1 <br />Sterilization date: <br />2020-09A4 <br />Sterilization lot: <br />18473 <br />Customer. <br />MT.DERM GmbH <br />Your requisition no.: <br />09092020 <br />GB1=20EB2545 GB3=20EB2583 <br />Our delivery note: <br />252154 from 2020-0947 <br />Item: <br />9900031 <br />Sterilisation Pal. MP01 1d NK <br />Pr.70 <br />Quantity: <br />2 Pal. <br />Nominal values <br />Actual values <br />Incoming time: <br />(April to October not required) <br />Preconditioning <br />Dwell: <br />min. 16 h <br />77 h <br />Conditions: <br />35-05°C 5080% rel. humidity <br />35.45°C 5080% rel.humidity <br />Sterilization <br />Cycle: <br />MP1 <br />Temperature: <br />40:t3 °C <br />400C <br />Prevacuum: <br />120 t10 mbar abs <br />124 mbar abs <br />Humidity: <br />50-80%rel.humidity <br />65%rel.humidity <br />Dwell time: <br />3 h <br />3 h <br />EO mass: <br />1632 kg <br />26 kg <br />Air washes: <br />min. 3 <br />3 <br />enation <br />Dwell: <br />min. 1 Days <br />2 Days <br />Condition. <br />35-45 °C <br />36460C <br />Remarks: The <br />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 />ndicators (Bacillus atrophaeus, 3M Attest). <br />The sterilization was conducted in line with the customer validation parameter. <br />Signature QS: Date: �7'i�rJO <br />