Medistri..SA ‘Title er Repo: ‘Validation Report of Sterility Testing of Amustininedcl Chan m Report of Sti Di Seen 2020 ‘con F2L-b Vesa 7 soret 7st iy Mal SA Informs Te Tine 6 TRI ReaD il CH 1564 Domdidier Fax : 0041 26 676 9085. Come car Cason as Easiaie Casona’s ee (Osan awe oer) | Ofer 20003 Dat stn afte rds 25° Seen 2020 Post ieieon Gane antewe) | HIO/ MeN Howe Mtg ah a tts Paling oe Dink son canes ED Slang 1 ie 1: — Cn BS Goma : Sting cnitins Fitters Se sachs ne itn site EoD at comer Cy fp ‘samp uy fea ‘vation aon Fiom25* Sener 2020107 September 2.0 Method “The present document reports on the validation ofthe method wed fo lest Ie selity of medical devices, according to EN ISO 11737-2 and Mest intemal procedure W133. 3.0 Results, “Growthin | Waren at | Conse em sain | fuinocobes* | prnnce ot ‘wowe | “onfem | protege) | (gases | ‘Saurens | NoTC ToT [31 Yes Passed Yes Paeruginasa | NCTC 1934 [36 Yes Passed Yes C-sporogenes | NCTE 12935_[ 21 Yes Passo Yes Bcsubtiis | NCTC 10100 [18 Yes Passed Yes albicans [ROPER [30 Yer Pier Yer “A brasilensis_| NCPF 2275 — [18 Yes Passed Yes + cuntaive yetifaton by string ofthe nau suspension on TSA. Taleace links age betwee 10 tnd 10 quale verifetion of growth by sbcuing ofthe medium in pesence af the pode “The sterility testing i validated for BIO / MeMo Flowcel in 200m of medium, (austin 09 Farmer me peasy PAGE: ‘ivr on ae ee geath Tilers eparn: 276 Medittr’. SA aan Repro Ser Testing FaLbveson 07 sore 7515 Copy Mesn SA Introduction Ts evaluate the inhibitve properties ofthe product potaally Teadng to false negative resulis using the method of direct immersion ofthe produ inthe culture medium. Inhibiive properties are evnluatet hy innculating small amount of microorganism to the culture medium in presence ofthe product. A growth signifies that te product isnot inhbiive to microbial growth and can be tested for stelity test of medical devies after sterilization. Growth must be detetable and countable within the time indicated in chap 6.3, ‘otherwise the validation is considered as non-eonform and further investigation may be requied Routine. The sterility testis peeformed under aseptic conditions, in a clean room under a ricrobiologial safety cabinet. The working precautions taken do rot affect the ‘microorganism searched for. The operaiory conditions when performing the tests are ‘monitored by microbiological contol of at and working surfaces, 5.0 Materiel 5-1 Product tested: BIO / MeMo Floweell, Par of the product used forthe test: Entire product Dotter: aa Volume of medium used: 200 mi 2 Microorganisms used for validation ‘© Staphylococcus aureus ‘+ Clostridium sporogenes © Bacillus subsilis ‘+ Pseudomonas aeruginosa © Candida albicans + Aspergillus brasiliensis 5-3 Culture media + Liquid thyoglycolate medium (THO): forthe detetion of aerobic and anaerobic ems ‘+ Liu uypwane soja meutum (TSB): for dhe detection of serobie germs, yeast and moulds 5-4 Material and equipment ‘+ Clean room and microbiological safety cabinet + Sterile containers ‘Sterile instruments for handling aur 0 tert PAGE:2MMedistr SA) saan ita seme Validation Report of Sterility Testing of ‘Armuatnmedical Chain ie pehlnetrelt Dav Sepenber 2020, cl F2Lb Versi: 7 soPE75.15 Copy: Medi SA 6.0 Method ‘=I Preparation ofthe ocuTim Tor validation The microbial suspensions ae prepared and adjusted o 10 100 ef, 6-2 Validation For each type of microorganism specified under 5.2, transfer the device to tet into the culture ‘medium. inoculate with an inoculum contsining 10 - 100 efu from each stain. Incubate according to section 63 In parallel, perform a count by transfering the same inoculum of suspension onto a TSA plate, and incubate S days at 33°C (min 30°C; max 35°C). The C. sporogenss strain needs to be incubated under anacrobie conditions ‘After growth inthe broth culture media and in presence ofthe product, perform a subculturing to confi that growth corresponds to the germ inoculated. 6-3 Overview co Sa Tene Sawer (NCTC Tae 335 Poorinsa [NCTC S24 3c (Csporagenes [NCTC 1935 50-35] 3 baie NCTC TON 20-25 3 -albicant ——[ NCPFSIT9 30-25 | Sdn | Besos NOPE IIS 20-28 _| Says | roth st Be dita within in ned tore he waitin considered es noncoir 6-4 Routine ‘+ Aseptcally remove the samples fom their package and transfer one of them into TSB fad the second one into THIO in 200m of medium. Hermeticlly close the containes Prepare the respective negative controls. Incubate 14 days at 30-35°C for THIO and 20-25°C for TSB. Examine the media to check for macroscopic development of microbial growth, there is no grow at the end of incubation, te batch of de proxi asi tity vesting. ear 0 ‘een berate PAGE: 34 vient) ea ed agnr ‘ile tne: Reportno: 27468 Medical Devies for: Dae: Senet 20 car F2L-DVenion 87 Co esa 2.0 Validation acceptance criteria If after incubation s mierobial growth is clearly visible, visually comparable tothe postive ‘contro, the product doesnot have any antimicrobial activity in the conditions of testing o it antimicrobial activity has been removed ina satisfying way. The sterility testng ean then be performed without futher aoiictions, 8.0 Conclusions ‘The testing method used to perform the medical devices’ sterility testing onthe product is validated and the results are evaluated as conform according to EN ISO 11737-2 9.0 Approvals Date: 30 September 2020 pate; 30! Sephenser 202 Laboratory Bepactment: i) Quay Deparment, 10.0 Attachments Picture of entire a Picture ofthe product in medium uate TASES ee ne mara