REPORT OF ANALYSIS No. 8342/13/GDY
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1 Client: Subject: (according to declaration of the Client) ZAKŁAD PRODUKCJI SPRZĘTU MEDYCZNEGO "RAVIMED" SP. Z O.O. UL. POLNA ŁAJSKI K/LEGIONOWA CHA-HA NON- IRRITATING ANTIBACTERIAL FLUID Marking of the sample: CHA-HA NON- IRRITATING ANTIBACTERIAL FLUID PET bottle with 75ml capacity Sample received Analysis completed TEST METHOD Unit Result Hygienic handwash PN-EN 1499:2000/Ap1:2001-1) 1) According to PN-EN 1499:2000/Ap1:2001 Chemical disinfectants and antiseptics. Hygienic handwash. Test method and requirements (phase 2/step 2) CHA-HA Non- irritating antibacterial fluid exhibits bactericidal activity against transitional microorganism used in hygienic handwash procedure - rubbing off the hands 5 ml of product for 30s Results in Annexes: TABLE 1 TABLE 2 TABLE 3 TABLE 4
2 TABLE 1 A) IDENTYFICATION OF THE SAMPLE: Name of the product CHA-HA NON- IRRITATING ANTIBACTERIAL FLUID Manufacturer/Supplier Zakład Produkcji Sprzętu Medycznego "RAVIMED" Sp. z o.o. ul. Polna Łajski k/legionowa Active substance Chlorhexidine Digluconate 0,2g B) TEST METHOD AND ITS VALIDATION: Method Neutralizer PN-EN 1499:2000/Ap1:2001 Chemical disinfectants and antiseptics. Hygienic handwash. Test method and requirements (phase 2/step 2) Polisorbat 80, 30 ml/l, soponina 30g/l, histidine 1g/l cysteine, 1g/l C) EXPERIMENTAL CONDITIONS: Analysis period Appearance product dilutions Clear solution Product test concentrations (%V/V) 100%, rubbing off the hands 5 ml of product for 30s Test temperature 20 C Contact time rubbing method- 30s Temperature of incubation 37 C Identyfication of the bacterial strains used E. coli K12 NCTC 10538
3 E) Conclusions According to PN-EN 1499:2000/Ap1:2001 Chemical disinfectants and antiseptics. Hygienic handwash. Test method and requirements (phase 2/step 2) CHA-HA Non- irritating antibacterial fluid exhibits bactericidal activity against transitional microorganism used in hygienic handwash procedure - rubbing off the hands 5 ml of product for 30s
4 TABLE 2 HYGIENIC WASH TEST PROCEDURE NAME OF PRODUCT: SOFT SOAP ANALYSIS PERIOD : STRAIN OF BACTERIA: E. COLI K12 NCTC PREVALUE: 2,4X 10 9 JTK/G NEUTRALIZER: POLISORBAT 80, 30 ml/l, SOPONINA 30G/L, HISTIDINE 1G/L CYSTEINE, 1G/L No PREVALUE MEAN VALUE POSTVALUE MEAN VALUE REDUCTION FACTOR difference , ,49 2, , ,61 2, , ,68 2, , ,84 2, , ,71 2, , ,34 2, , ,82 2, , ,61 2, , ,64 2, , ,85 2, , ,77 2, , ,96 2,33
5 TABLE 3 HYGIENIC WASH TEST PROCEDURE NAME OF PRODUCT: CHA-HA NON- IRRITATING ANTIBACTERIAL FLUID ANALYSIS PERIOD: STRAIN OF BACTERIA: E. COLI K12 NCTC PREVALUE: 2,4 X 10 9 JTK/G NEUTRALIZER: POLISORBAT 80, 30 ml/l, SOPONINA 30G/L, HISTIDINE 1G/L CYSTEINE, 1G/L No PREVALUE MEAN VALUE POSTVALUE MEAN VALUE REDUCTION FACTOR difference , ,04 3, , ,18 3, , ,23 3, , ,69 3, , ,43 3, , ,53 3, , ,23 3, , ,47 3, , ,33 3, , ,32 3, , ,33 3, , ,04 3,96
6 Table 4 COMPARISON OF REDUCTION FACTORS 1.Reduction factor standard handwash - SOFT SOAP 2.Reduction factor standard handwash - CHA-HA NON- IRRITATING ANTIBACTERIAL FLUID NO 1 2 difference 1-2 2,71 3,98-1,27 1 2,64 3,85-1,21 2 2,59 3,73-1,14 3 2,35 3,33-0,98 4 2,68 3,68-1,00 5 2,85 3,61-0,76 6 2,30 3,72-1,42 7 2,70 3,54-0,84 8 2,63 3,83-1,20 9 2,36 3,84-1, ,50 3,77-1, ,33 3,96-1, ,55 3,74-1,18 mean value Test validation: 1) the mean value of the logarithms of the prevalue > 5 2) the mean reduction factor for the preparation CHA-HA NON- IRRITATING ANTIBACTERIAL FLUID is significantly larger than that with soft soap
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