Cleaning Efficiency of The MicroOne Wipe and Mop Cleaning System

Transcription

1 PDA Laboratories, Inc. A Contract ing Laboratory Visit us at 17A Kiel Avenue Kinnelon, NJ (Tel) (Fax) pdainfo@pdalabsinc.com Cleaning Efficiency of The MicroOne Wipe and Mop Cleaning System Sponsor: Study Director: Vileda Professional Leo Gubenko, Global Technical Manager Product Description: MicroOne Wipe and Mop Cleaning System. PDA GLP ing Protocol: PDAP , R1 (PDA Labs. Quote) PDA Receiving # R20537 Date Received: 09/12/2016 Date On: 09/13/2016 Date Off: 10/07/2016 ing Facility: PDA Laboratories, Inc. Study Director: Artur Lewandowski, MS` Quality Assurance: Silmarie Guzman. Product Information: 1. New bulk of 50 wrapped, MicroOne, single use microfiber wipe, size 34 x27cm, BCU , TSU: New bulk of 25 wrapped, MicroOne Pocket 40cm Mop Pads, size 42 x12cm, BCU150387, R of 7

2 PURPOSE: To determine the cleaning effectiveness of the MicroOne Microfiber Wipe and MicroOne Mop EQUIPMENT AND MEDIA Incubator (30 to 35C) PDA # A004 Laminar Flow Hood PDA # A030 Bio-Safety Cabinet PDA # A028 Sterile Trypticase Soy broth Broth (TSB) Lot # M Exp. 07/22/2017 Sterile Trypticase Soy Agar (TSA) Lot # M Exp. 12/07/2016 Saline 0.85% 9 Normal lot # M Exp. 05/25/2017 RODAC Plates TSA w/lec. + P80 M Exp. 10/26/2016 Timer PDA # S/N BD Culture Swabs Lot # 01 OF 38 L. C5S715 Exp. 09/2017 Reagent Water Vortex, Sterile Petri Dishes, Sterile Glass Containers, Sterile Spray Bottles. Armstrong Commercial Vinyl Floor Tiles Everbilt less Steel 304 Metal Sheet. PROCEDURE 1. Preparation of Organisms and ing Surfaces Preparation of testing surface. Two types of surfaces will be prepared for the test: less Steel for MicroOne Microfiber Wipe and PVC floor for MicroOne Mop. The surface will be sterilized using Spor-Klenz disinfectant. The surface was sterilized using 3 applications of Spor-Klenz prepared as per manufacturer label recommendation for sterilization purposes (1 part of Spor-Klenz into 99 parts of Reagent Water). After disinfectant application, surface was left for 10 minutes and the following two additional applications were performed. The final cleaning was performed using sterile reagent water. 1.2 Preparation of ing Organism. (received from Microbiologics) forty (40) TSA s were inoculated with and incubated anaerobically at 30-35C for up to 7 days. Spore suspension. After incubation, using twenty (20) inoculated TSA s the suspension was prepared and heat shock was performed to eliminate the vegetative cultures. The suspension was tested using standard operation procedure for population verification. The final concentration 10E8/1ml was achieved. (See table #10)_ R of 7

3 Bacterial suspension. After incubation, using twenty (20) inoculated TSA s the suspension was prepared. The suspension was tested using standard operation procedure for population verification. The final concentration 10E8/1ml was achieved. (See table #1). 1.3 The Inoculum Preparation of Microorganisms. spore form 10 ml of 10E8 suspension was diluted 10 times using sterile Saline to achieve final concentration of 10E6-10E7/1 ml. (see Table #2) vegetative form 10 ml of 10E8 suspension was diluted 10 times using sterile Saline to achieve final concentration of 10E6-10E7/1 ml. (see Table #2) TABLE #1 Individual Suspensions, Initial Concentration Final Concentration Organism ID # Plate 1 (10E-7) Plate 2(10E-7) ATCC x 10 8 (spore form) (vegetative form) ATCC x 10 8 Analyst/Date 09/19/2016 AL TABLE #2 Individual Organisms Suspensions, Final Concentration used to inoculate surfaces. Organism ID # (spore form) (vegetative form) Analyst/Date ATCC 9689 ATCC 9689 Final Concentration Plate 1 (10E-6) Plate 2(10E-6) x x /19/2016 AL 2. Contamination of the ing Surfaces using freshly prepared microorganisms suspensions. 2.1 Floor PVC floor. The contamination of the floor was accomplished by spraying the surface individually and separately with prepared microorganisms suspensions respectively until the floor surface was visually wet. After inoculation step, the surface was left for drying. The right, top area of the surface was used for positive control. The left, top area was not inoculated and was used as a negative control. 2.2 less steel. Contamination of stainless steel surface was accomplished by spraying the surface individually and separately with prepared microorganisms suspensions respectively until stainless surface was visually wet. After inoculation step, the stainless steel surface R of 7

4 was left for drying. The right, top area of the stainless steel surface was used for positive control. The left, top area was not inoculated and was used as a negative control. 3. Manual cleaning For each surface, manual cleaning by applying hand force was performed. By gentle pressing the wipe on the stainless steel surface and mop on PVC floor separately and individually, the cleaning process was performed for contaminated areas. 4. Organism Recovery from the test samples (Quantitated and Qualitated). 4.1 Floor Type PVC Floor (cleaning with MicroOne Mop). After initial inoculation of the floor surface with microorganism, individually and separately, manual cleaning using the MicroOne Mop saturated with purified water was performed per operating procedure.. The cleaning efficacy of the MicroOne Mop saturated in purified water was determined by using quantitated and qualitated test methods, and the extraction of the microorganisms from the mop using sterile reagent water and plating method. The test results from Mop and Wipe show that the removed organisms were present in the testing product and testing results are presented in the tables below. See table #3 and #4. Quantitated Method by using swabs, testing area approximately 25 sq.cm/swab (each swab will be taken from the area of 5cm x 5cm using vertical and horizontal swabbing directions) Qualitated Method by using Rodac s, testing area approximately 25 sq.cm/. Date: 09/30/2016 Technician: AL TABLE #3 Microorganism: (spore form) and PVC floor. Sample Quantitated ing Method Qualitated ing Method Mop Cfu/ Purity +C A 188, x C A 179, x N/A R of 7

5 TABLE #4 Microorganism: (vegetative form) and PVC floor. Sample Quantitated ing Method Qualitated ing Method Mop Cfu/ Purity +C A 198, x C A 189, x N/A Table Terminology CFU = Colonies Forming Unit +C = Positive Control -C = Negative Control NC = Neutralization Challenge, performed on all negative count s to exclude any inhibitory activities of the microbial growth. Each was challenge with <100 cfu of tested group of microorganisms. + = Positive results for NC N/A = Not Applicable GPB = Positive Bacillus 4.2 Surface Type less Steel (cleaning with MicroOne Wipe). After initial inoculation of the stainless steel surface with microorganism, individually and separately, manual cleaning, using the MicroOne Wipe saturated with purified water was performed per operating procedure. The cleaning efficacy of the MicroOne Wipe saturated in purified water was determined by using quantitated and qualitated test methods and the extraction of the microorganisms from the wipe using sterile water for injections and plating method. The testing results are presented in the tables below. Quantitated Method by using swabs, testing area approximately 25 sq.cm/swab (each swab will be taken from the area of 5cm x 5cm using vertical and horizontal swabbing directions) Qualitated Method by using Rodac s, testing area approximately 25 sq.cm/. R of 7

6 Date: 09/30/2016 Technician: AL TABLE #5 Microorganism: (spore form) and less Steel surface. Sample Quantitated ing Method Qualitated ing Method Wipe Cfu/ Purity +C A 159, x C A 185, x N/A TABLE #6 Microorganism: (vegetative form) and less Steel surface. Sample Quantitated ing Method Qualitated ing Method Wipe Cfu/ Purity +C A 198, x C A 186, x N/A Table Terminology CFU = Colonies Forming Unit +C = Positive Control -C = Negative Control NC = Neutralization Challenge, performed on all negative count s to exclude any inhibitory activities of the microbial growth. Each was challenge with <100 cfu of tested group of microorganisms. + = Positive results for NC N/A = Not Applicable GPB = Positive Bacillus R of 7

7 STUDY SUMMARY TABLE #7 Summary Table MicroOne Mop On PVC Floor Microorganism MicroOne Mop MicroOne Mop Group Inoculum Results Spore form Vegetative form = 7.28 = 7.26 = 7.32 = 7.28 Survivors Reduction (% Reduction) from Mop TABLE #8 Summary Table MicroOne Wipe On less Steel surface. Microorganism MicroOne Wipe MicroOne Wipe Group Inoculum Results Spore form Vegetative form = 7.23 = 7.26 = 7.30 = 7.28 Survivors Reduction (% Reduction) from Wipe As per Summary Table # 7, the microbiological cleaning performance of the MicroOne Mop of the PVC floor surface and microbial contaminant is clearly demonstrated. As per Summary Table # 8, the microbiological cleaning performance of the MicroOne Wipe of the less Steel surface and microbial contaminant is clearly demonstrated. FINAL CONCLUSION The MicroOne Mop and MicroOne Wipe saturated in purified water removes the microbial contaminant (both in vegetative and spore form) with effectiveness of >99.999% (>5 log) reduction when compared to initial contamination levels. Therefore, the MicroOne Mop and MicroOne Wipe are validated to effectively clean and remove from stainless steel and vinyl surfaces. R of 7