STUDY REPORT DISINFECTANT EFFICACY EVALUATION OF ISO PROPYL ALCOHOL, MBIR20200011 2 a DISINFECTANT EFFICACY EVALUATION ‘STUDY REPORT FOR CuraTeQ Biologes Pred. |FOR REFERENCE ONLY| Page| ofteR Tad STUDY REPORT DISINFECTANT EFFICACY EVALUATION ISO PROPYL ALCOHOL Report No. [MB/R/2020011 Page 2 oF ‘TABLE OF CONTENTS [ S.No. a a Page No 1 [ Objective 4 2. Study Information 4 3__| Disinfesant Details : 3 4. | Summary Flow Chart 6 5. | PreRemisits 7 3.1, | Material Used for Sey a 7 52.__| Bavipment+ used for Sty 8 53,__| Name ofthe Challenging Organisms 3 | Methodof Study 9 6.1. __| Media Preparation | (62,___| Inoculum Pepa 3 (63.__| Test Soution (isinfetan) Preparation 0 (64, | Neutralizer Eficcy Test 0 65. | Neutralizer Toxicity Test 2 7.__| Disinfotant Eticay Evalaton oF PA 1 7.1. _| Disinfestan Efficacy Evaluation performed by Use Dilution Method 4 7.1 _| Log Reston calevlation formula 1 712.__| Disinfectant eficacyevalaton performed by Surface challenge Method 16 72.1. | Disinfotant efcay evaluation done with $8316 L. grado surice 7 72.2. | Disinfedant eicacy evaluation done with $8308 L surface » 723, | Disinfectant eticay evaluation done with Glass surface 20 72.4. | Disinfecant etficay evaluation done with Curtanssurface a_| 72.5, Disinfocan efficacy evaluation done with Wall paselsurace 2 7.2.6, | Disinfotant ficacy evaluation dane with Acrylic Door panel 2 72.21. | Disinfectant efficacy evaluation done with Epoxy 4 72.8,_| Disinfectant efficacy evaluation done with Gloves 2 729._| Disinfectant efficacy evaluation dove with PVC 6 73,__ | Holdtine study 2 73.1 | Disinfectant efiacy evaluation done with 98916 surface 28 73.2 _| Disinfectant efficacy evaluation done with SS3U4 surface 2 73. | Disinfect eflacy evaluation dove with Gass surfoce 30 734 _| Disinfectant efficacy evaluation done with Curtain surface a_| [FOR REFERENCE ontners) STUDY REPORT DISINFECTANT EFFICACY EVALUATION ISO PROPYL ALCOHOL Report No. | MB/R/2020/011 Page 3 of 41 73:5 | Disinfectant efficacy evaluation done with Wall panel surface 2 7.3.6 _| Disinfectant efficacy evaluation done with Acrylic Door panel surface 3 73.1 _| Disinfectant efficacy evaluation dove with Epoxy surfs a rn 7238 _| Disinfectant ficacy evaluation doe with Gove surface 35 7.39 _| Disinfectant efiacy evaluation done with PVC surfice 36 74, | Bioburden a7 | Deviations & Goncsive Acne Rept 3 9,__[ References 10, | ABbreviations Ey “11, | Summary and Conclusion 2 Se a |FOR REFERENCE ONL}STUDY REPORT DISINFECTANT EFFICACY EVALUATION ISO PROPYL ALCOHOL FPR) Report No. | MB/R/2020/011 Page 4 of 1. onsecrive “The purpose ofthis report is to compile the study resus of disinfectant efficacy of lo propyl alcohol, which shall be ued for clening and disinfection ofthe area and surfaces instep areas a time interval of 1,2 and 5 minutes 2, STUDY INFORMATION ‘Cestomer Det (CeraTeQBiologis Private Limited a ‘Survey No.77 and 78 Paskany/aram, Sangareddy District dit ‘Telangana 802529, DepartmenSuite ‘Microbiology Deparment Contact Person Ms, Niofar Bagban [Name ofthe Study Disinfoctan Validation Name of the Disinfectant so Propyl Alshol atch, No Ia/T06/20200305, Mig Date 2.112020 Expiry Date 24.11.2023 ‘Validated by ‘Umed Pharma Lab Pvt Ltd, Study Location ‘Une Phama Lab Pt. Lid Bashuply, Hyderabad ‘Are Deparinent Miobilogy Lab : Contact Person Me PS. Rest Pratoco tive Date 311-2020 Stay Started On 212-2020 Study Completed On 26-01-2021 Procol No. Moveze20011 Report No vm2020011 IFOR REFERENCE ONLY|STUDY REPORT DISINFECTANT EFFICACY EVALUATION ISO PROPYL ALCOHOL ReportNo. | MB/R/20200011 Page 5 of 41 3, DISINFECTANT DETAILS Tablet ‘Test Concentrations Iso propyl Alcohol-60%, 7% and 80% ah Na arrena20200305 Manfcring Date asaiane0 ig Dae i108 aie apa ei et Capon Nate fe diet All Bed [sresram Baca and geal inc |FOR REFERENCE ONLY|STUDY REPORT DISINFECTANT EFFICACY EVALUATION ISO PROPYL ALCOHOL Peni Ta-) Report No. | MB/RI2020011 Page 6 of 4. SUMMARY FLOW CHART ‘Inoculum Preparation ‘Serial Di Neutralizer Efficacy Neutralize Disinfectant evaluation Use dilution method & surface Challenge study Hold time study and Bioburden ‘Summary and conclusion |FOR REFERENCE ONLY|STUDY REPORT DISINFECTANT EFFICACY EVALUATION ISO PROPYL ALCOHOL, FPR sked Report No. | MI/R/2020/011 Page 7 of 41 5S. PRE-REQUISITES SA, Material sed for study: ‘Tablet e Media deta Media manufacturer Ia Howse emmbe! sndat No Expiry | media LocNos | P*PIY ‘SODATUTIOIO | T7-UEROAI SeDax012011 | 18:062021 sScba2012012 | 18-06-2021 i SCDA2012013 | 22-062021 Soyabean Cascin Digest Agar May2ms | Scba2012014 | 23.06.2021 cemeaaed Scba2012015 | 28062021 Scpazioi003 | 06-07-2021 Scbazioi00s | 07-07-2021 Scba2101005_| 08.07.3021 on scazoi2002 | 07-062021 Sebourat choramphenial ewe | Mires | gugaoas | SCaz012005 | 6:06:02) ScA2012008 | 09-06-2021 DENBIOTAOOT | Oa-06amAI — DeNf2012003 | 08-06-2021 ‘ey Enaley Neutralizing Broth terres | san.ams | DeNI2012004 | 09-062021 DENB-2002 DeNR2012005 | 10-06-2021 _ DeNB2I01001_|06-07.2021 uffred sodium Chloride Mironpress foe Aconpess | ep.2025 | sczoii002 | 26.05.2021 a ——pwaoizai8 | Fraszoar pw2012019 | 27-062021 pu20i2n20 | 28-062021 Microxpess w2012021 | 30-06-2021 eae PW.2003 July2028 | pwya0r2022 | 30-06-2021 pwnioioot | 01-07 ant Pwrioio0z | 02.07.2021 pwaioions__| 2-07-2021 -NACLOI2001 | 315-2021 ‘Nact2012002 | o1-062021 Nact2012003 | 03-072021 ‘ ined [NACL2DI2011 | 25.06.2021 Siam Chloride pier oxe2022 aicora0a1 s.o72mi [NACLALOI00S | 053-2021 NacLat01006 | 06-07.2021 ‘OR REFERENCE ONLx} NACL2O1007_| 07-07-2001es [zeae = _ STUDY REPORT DISINFECTANT EFFICACY EVALUATION ISO PROPYL ALCOHOL, Parcitiibad | Report No. | Mne/2020/011 Page #of 52, Ravipmens wed forstndy: ‘ables Name of te astrument Equipment W.No | CalWal Done. | CalWal Doe Weighing Base ‘wnwwaoor | vraranr | 10a wie ‘MBrPHo01 Daly ‘Autochve Staton) ‘wvauroor | otanana0 | o.0o.n0ai LAF [Laminar Airflow mi} =| MBVLAFOOT 17-10-2020 16042001 TAF (laminar Ai ow ot ‘mowarom | 1710200 | —_r6aea0a1 TAF (Laine iro eit) MaiLarons | Tev02m9 | teox2oni Mier Pipe vuonanoor | iwinaea0 | ise6aai Micro Pipette ‘Mpnap/002 16122020 15.06-2021 [ior Ppete | mnamoes | 16-12-2020 1506-2001 Vorecmeter vnwwioor | 24062000 | 23-06a0ai ‘Stop Watch MBySw/00s 23062020 | 22-06-2021 Incubator [30 35°C] Mamopieo2 | 01-09-2020 ‘3-08-2021 Incr (20-25°C) ‘omooioo; | o1oae | a10Ra02i Digit Colony Comte mccin | 060x201 | _os-0620ai Reiertor Mommroon | tnava0%0 Deep-freezer MB/DF/001 03-12-2020 - Maint no) NA NA np ‘M01 NA NA ‘Horizontal Rectangular Autoclave MB/HRAUTIOO! rar200 | Destustion Autoclave MBvauo02 | 22.09.2020 21-09-2001 Water ba waarwaio | 20002000 | wos-20nt | Walk-in incubation Room Marwinvoor | 3009-2020 129.09-2021 ‘Walk-in incubation Room | sarwinoor | 3009-2020 39-09-2001 Mire ——|-eaacemi—| vg NA FOR REFERENCE ONLY|STUDY REPORT DISINFECTANT EFFICACY EVALUATION 180 PROPYL ALCOHOL Re = Teportne | iN/B0001 [ose rar 53, Rane of ie Cheng Orga os ‘abe S Nanette Onin Sean. Lose arocen 1 spit eee sxsa0sa nroear. 2 | __ Behehact areca) sas alos erga Aiea 3 Poona ag ‘Atco or nica a ac is Aree “aes812 Arce 5 ol a ATEC03 “40804 an ‘ce ete ri “ape ato acest ‘soar 1. ee IS/EMISP18/0048 ‘NA . — IER NA 2» |___Sepio pemis Issmienrs NA . panera IS ISae NA 0 oii IESE NA 2 Fcc sar IEwsmieno%9 NA 13 | tacoma meni p Gemors | _ INEMINIBOH NA va] Peadonna onan Sven Na 18] S8gomoas ono ISIEMSPni8Ors NA 16 | _Senarphonoa atop ISEMISIN0017 NA ‘Ae IsiEMsPi8ons NA a] Beihai cactomer ISEMISP ison NA ws. tcl ISEMISFINOn56 NA cn] Allon cies IST NA Meron oF srepy 64, Media Preparnt Propriety mada an ten te ma per SOP MBO. 62. noes Peart Prep te ied ga 1702 nd perme he FOR. ton rom 100 10% CFULS tke Base NYSTUDY REPORT DISINFECTANT EFFICACY EVALUATION ISO PROPYL ALCOHOL, Report No. | MB/R/2020(011 Page 10 of 63. Test Solution Disinfectant) Preparation Required disinfectant concentationswere prepared as per the below tble-V and stored in a steriecontinr at 20.25°C and used for disinfectant efficacy evalaton. Disinfectant concentrations Vs, Contact time - “Tablev ei ‘Preparation Procedure : Contact time Disinfectant | Concentrations |—pisinfectantin | Purified mace, al. water in mL om 600m! amt | 1 | 2 | s Isopeopy Alcohol 0% 700m som | 1] 2 fs 80% 00m! rom | | 2 fs 64. Neutralizer Eicacytest: + Taken one text be contining S ml. of DENB and 2 test tube contining 10 nl of BSCP. 1 tet tube served a et sample and 2“test abe served as text postive cont IPA. 80% concentration used for the neutralizer efficacy study. This i the highest concentration wed in the std, + To 5 ml. of disinfectant solution added in $ mL of DENB and gently shake ts tbe and kept infor S minutes. + Added NMT 100 CFU ofthe eltre suspension to each of test sample (test tbe) and test postve contol (2 test tbe). “After addon of inoculum geatly mixed the tes tubes. + Filed the sample trough trl 0.4S ym membrane file, afte ilvation, membrane rinsed ‘with 100 sterilized 0.1% peptone water + Aseptically ansfoned the membrane fier on media plates (90 mm). Usse SCDA for ‘bacteria elures and SCA fo fangs cultures + Incubate the SCDA plates at 3010 35°C for <3 ays for bacterial cultures and SCA plates at 20 025°C for 4 FOR REFERENCE ONL