Surface Fungicidal Activity of Clinell Universal Wipes ~ Project Report Prepared for Gama Healthcare Ltd.

Transcription

1 Surface Fungicidal Activity of Clinell Universal Wipes ~ Project Report Prepared for Gama Healthcare Ltd. Inspiring tomorrow s professionals

2 Surface Fungicidal Activity of Clinell Universal Wipes Author: S. Rout Signature: Date: Checked: J.Campbell Signature: Date: Authorised: P.Humphreys Signature: Date: Report No: HyDis/GAMA/UNIV/21/8/15 ISSUE: Date: Draft for Comment Version 1 21/08/15 Whilst these analyses have been carried out carefully and have been checked, no liabilities can be accepted for consequential or indirect damages. 1

3 1 Introduction A sample of Clinell Universal Wipes were provided for analysis of surface fungicidal activity employing BS EN13697:2015 against Aspergillus brasiliensis under dirty conditions. 1.1 Product Wipes were squeezed by hand within a Class II safety cabinet to express the product as a foam. The collected foam was then left for ca.20 minutes to return to a liquid form. This liquid was then used for subsequent analysis. 2 Test Procedures 2.1 BS EN13697 The test was carried out as specified by BS EN (Appendix 1). Of the standard test micro-organisms outlined within the standard, Aspergillus brasiliensis ATCC was selected to assess fungicidal activity. Briefly, the candidate fungi was prepared to a test concentration of x10 7 cfu ml -1, where spores were visually inspected to ensure a high concentration of mature spores. 1 ml of fungal test suspension was added to 1 ml of interfering substance (6 gl -1 Bovine Serum Albumin (BSA) Dirty conditions) 2 minutes prior to commencement of the test. Sterile stainless steel test surfaces (2 cm diameter with Grade 2 B 3 ) were then inoculated with 0.05 ml of test suspension and dried until visibly dry in a 37 C incubator. The inoculated surface was then treated with 0.1 ml of product. After a contact time of 15 minutes at 25 C, the surfaces were transferred face down into sterile pots containing 10 ml of neutraliser and 5 g glass beads, shaken at 150 min -1 for 1 minute before a total neutralisation time of 5 minutes was allowed at 25 C. The number of surviving fungi was then determined by plating out neutralisation mixture onto malt extract agar followed by incubation at 30 C for 48 hours. Following incubation the fraction of surviving fungi was noted and a Log reduction factor calculated by comparing with a water control (Appendix 1). In addition to the test procedure outlined above, a range of validations were performed to ensure the validity of the test (Appendix 1 and 2) Requirements of this standard The product, when tested as stipulated under simulated clean or dirty conditions (0.3 gl -1 or 3.0 gl -1 bovine albumin) under the test conditions for fungi (25ºC, 15 minute contact, for the selected reference strain), shall demonstrate at least a 3 log 10 reduction in viable counts. At the customers request the test was carried out using Aspergillus brasiliensis only under dirty conditions. Whilst these analyses have been carried out carefully and have been checked, no liabilities can be accepted for consequential or indirect damages. 2

4 2.2 Neutraliser The neutraliser used for this test contained: dissolve 12g/L Tween 80 (Polysorbate 80), 12g/L Saponin, 0.4g/L L-histidine and 0.4g/L L-cysteine in 1000ml de-ionised water. Mix thoroughly with a magnetic flea. Add the mixture to a Schott bottle and autoclave for 121ºC. 3 Results and Conclusions When tested under the stipulated conditions, the results obtained (Appendix 2) show that the liquid expressed from the Universal wipes when tested in triplicate generated a mean Log reduction in fungal spores of Therefore the expressed liquid was capable of generating the >3 Log reduction required to pass the test under dirty conditions against Aspergillus brasiliensis. 4 References 1. BSI (2015) BSEN 13697:2015. Chemical disinfectants and antiseptics Quantitative non-porous surface test for the evaluation of bactericidal and/or fungicidal activity of chemical disinfectants used in food, industrial, domestic and institutional areas Test methods and requirements without mechanical action (phase 2, step 2).. British Standards Institute, London. Whilst these analyses have been carried out carefully and have been checked, no liabilities can be accepted for consequential or indirect damages. 3

5 Appendix 1. BS EN Flow Sheet. Whilst these analyses have been carried out carefully and have been checked, no liabilities can be accepted for consequential or indirect damages. 5

6 Appendix 2: Results Organism Water Control Nc Control Validation NC Test Validation NT Stock Test Nd A.brasiliensis 10^-2 > ^-2 > ^-2 > ^-5 > N Conditions Dirty 10^ ^ ^ ^ Coupon Nts 9 10^-4 < ^-4 < ^-4 < E E+02 Coupon E+05 Coupon E+05 Coupon E E+07 Nd Nc 6.13 NC 6.11 NT 6.13 N 5.94 Microbiocidal Effect 3.43 Conditions N must be between 5.57 and 6.10 Logs, where N= 5.94 Yes Pass criteria= >3Log reduction Yes Nc must be greater than 5.27 Logs where Nc= NC must be greater than 0.5 x Nc where 0.5Nc= NT > 0,5 Nc is not greater than ± 0,3, NT-0.5Nc= Nts Must not be greater than Yes 3.06 Yes 0.3 Yes 9 Yes Organism Water Control Nc Control Validation NC Test Validation NT Stock Test Nd A.brasiliensis 10^-2 > ^-2 > ^-2 > ^-5 > N Conditions Dirty 10^ ^ ^ ^ Coupon Nts 12 10^-4 < ^-4 < ^-4 < E E+02 Coupon E+05 Coupon E+05 Coupon E E+05 Nd Nc 6.13 NC 6.11 NT 6.13 N 5.94 Microbiocidal Effect 3.55 Conditions N must be between 5.57 and 6.10 Logs, where N= 5.94 Yes Pass criteria= >3Log reduction Yes Nc must be greater than 5.27 Logs where Nc= NC must be greater than 0.5 x Nc where 0.5Nc= NT > 0,5 Nc is not greater than ± 0,3, NT-0.5Nc= Nts Must not be greater than Yes 3.06 Yes 0.3 Yes 12 Yes Organism Water Control Nc Control Validation NC Test Validation NT Stock Test Nd A.brasiliensis 10^-2 > ^-2 > ^-2 > ^-5 > N Conditions Dirty 10^ ^ ^ ^ Coupon Nts 12 10^-4 < ^-4 < ^-4 < E E+02 Coupon E+05 Coupon E+05 Coupon E E+05 Nd Nc 6.13 NC 6.11 NT 6.13 N 5.94 Microbiocidal Effect 3.46 Conditions N must be between 5.57 and 6.10 Logs, where N= 5.94 Yes Pass criteria= >3Log reduction Yes Nc must be greater than 5.27 Logs where Nc= 6.13 Yes Mean LogRDN= 3.48 NC must be greater than 0.5 x Nc where 0.5Nc= NT > 0,5 Nc is not greater than ± 0,3, NT-0.5Nc= Nts Must not be greater than Yes 0.3 Yes 12 Yes Whilst these analyses have been carried out carefully and have been checked, no liabilities can be accepted for consequential or indirect damages. 6