Technical Data Monograph. Cleaning Efficacy of Prolystica HP Enzymatic Manual Cleaner Comparison to Other Manual Cleaning Products (International)

Transcription

1 Technical Data Monograph Cleaning Efficacy of Prolystica HP Enzymatic Manual Cleaner Comparison to Other Manual Cleaning Products (International)

2 Table of Contents 1. Background Purpose Methods Results Conclusion

3 1Background There are a multitude of soils that present difficulties in the cleaning of surgical instruments. The most common and some of the most difficult to clean of these soils are protein and fat. Real world conditions dictate that these soils are present on instruments together. Therefore, the ability to clean all of these soils with one product is clearly an advantage in productivity, turnaround time, and cost. There are a variety of ways to clean surgical soils, one of these mechanisms of cleaning being the use of enzymes. At neutral ph, enzymes are very effective cleaners. Protease enzymes are effective against protein and lipase enzymes are used for fatty soils. However, enzymes are not the only component of a product that determines the ability to clean. Surfactants play a major role in cleaning soils from a surface, especially fats. An optimized surfactant system has the ability to clean fatty soils better than lipase enzymes, as will be demonstrated with the following testing. 2Purpose Prolystica HP Enzymatic Manual Cleaner 1 is a concentrated liquid detergent designed for use in manual and ultrasonic cleaning applications for the processing of surgical instruments. The purpose of this study was to compare the cleaning efficacy of Prolystica HP Enzymatic Manual Cleaner and six additional manual products against a combination of surgical soils. This testing is applicable to the following products: Prolystica HP Enzymatic Manual Cleaner Dye & Fragrance 1C23 Prolystica HP Enzymatic Manual Cleaner 1C24 3Methods Method 1: Evaluation of Protein Cleaning Using a Protein Film Strip Test (Gelatin) The protein film strip test uses exposed and developed black and white 35-mm photographic film. The photographic film is coated with an emulsion layer composed of gelatin, which is a protein. The film strip is initially black. As a cleaner breaks down and removes the protein, the film becomes clear. Comparisons between enzymatic products were achieved by measuring the time required to breakdown and remove the protein from the test film and thus turn it from black to clear. The products were prepared at recommended use dilution in tap water at 40 C (104 F) and/or 50 C (122 F). The film strips were then suspended in the product dilutions with agitation. The time to completely clean was recorded. Method 2: Evaluation of Fatty Soil Cleaning Using Crisco All-Vegetable Shortening Fatty soil (Crisco All-Vegetable Shortening 2 ) was applied to stainless steel coupons and allowed to dry overnight. The coupons were weighed and then placed in a product solution (Table 2) in 50 C tap water. The solutions were agitated during cleaning using a stir bar for 3 minutes. After the allotted time of exposure, the coupons were then removed from the product solution, rinsed with deionized water, and allowed to dry. The percent removal of soil was determined by weight and photographs were taken. 3

4 Method 3: Evaluation of Synthetic Surgical Soil Cleaning Using Blood/Bone/Fat/Tissue Simulated surgical soil consisting of blood, bone chips, fat, and tissue was applied to hemostats and dried in a 50 C oven for approximately one hour. The hemostats were weighed and then placed in a solution of the products (Table 3) in 50 C tap water with agitation for 10 minutes. At 10 minutes, the hemostats were removed from the enzyme solution, rinsed with deionized water, and allowed to dry. The percent removal of soil was determined by weight and photographs were taken. Table 1. Enzymatic detergent products evaluated for cleaning efficacy Prolystica HP Enzymatic Manual Cleaner* Chemistry Use Dilution Tested 4 ml/l Aniosyme Synergy 5 Enzyme Detergent 3 4 ml/l Endozime AW Plus Multi-Tiered Enzymatic Detergent 4 Endozime AW Triple Plus with A.P.A. Multi-Tiered Enzymatic Detergent with Advanced Proteolytic Action and Rust Inhibitors 4 Endozime Xtreme Power Multi-Tiered Enzymatic Detergent with Advanced Proteolytic Action and Rust Inhibitors 4 PowerCon Triple Enzyme Detergent Concentrate 5 4 ml/l 4 ml/l 2 ml/l 4 ml/l Getinge Clean Enzymatic Detergent 6 10mL/L (Note: *Prolystica HP Enzymatic Manual Cleaner tested as the representative product.) 4

5 4Results Method 1: Evaluation of Protein Cleaning Using a Protein Film Strip Test (Gelatin) Prolystica HP Enzymatic Manual Cleaner completely cleaned the film strip in less than 5 minutes at 50 C and slightly over 7.5 minutes at 40 C. The next closest competitors were Endozime AW Plus Multi-Tiered Enzymatic Detergent, Aniosyme Synergy 5 Enzyme Detergent, and Endozime AW Triple Plus with A.P.A. Multi-Tiered Enzymatic Detergent which cleaned the film strip completely between 5.5 and 6 minutes at 50 C and 7.5 to 10 minutes at 40 C. Endozime Xtreme Power Multi-Tiered Enzymatic Detergent cleaned the film strip in approximately 8 minutes at 50 C and approximately 13 minutes at 40 C. The poorest protein cleaning performance was exhibited by PowerCon Triple Enzyme Detergent Concentrate and Getinge Clean Enzymatic Detergent. Each product took between 9 and 11 minutes to clean the film strip completely at 50 C and 13 to 15 minutes at 40 C. Speed of Cleaning: Enzyma c Detergent Products* on Protein-Based Soil Film Strip (Gela n) Test in Tap Water (only brand names shown) Prolys ca HP Enzyma c Manual Cleaner Endozime AW Plus C (122 F) 40 C (104 F) Aniosyme Synergy Endozime AW Triple Plus Endozime Xtreme Power PowerCon Triple Enzyme Ge nge Clean Time to Clean (minutes) 5

6 Method 2: Evaluation of Fatty Soil Cleaning Using Crisco All-Vegetable Shortening Prolystica HP Enzymatic Manual Cleaner achieved greater than 99% removal of Crisco All-Vegetable Shortening with visually clean coupons at 3 minutes. The next closest competitors, Endozime AW Plus Multi-Tiered Enzymatic Detergent and PowerCon Triple Enzyme Detergent Concentrate, only removed 91 to 92% of the fatty soil and left a significant amount of residue remaining on the coupons. Endozime Xtreme Power Multi-Tiered Enzymatic Detergent, Aniosyme Synergy 5 Enzyme Detergent, Getinge Clean Enzymatic Detergent, and Endozime AW Triple Plus with A.P.A. Multi-Tiered Enzymatic Detergent ranged in soil removal from 79 to 83% and had visible soil remaining with redepositing of the soil being apparent Agitated Immersion Test: % Removal of Fa y Soil from a Stainless Steel Surface in 3 minutes at 50 C (122 F) by Enzyma c Detergent Products (only brand names shown) % Removal Tap Water Control Prolys ca HP Enzyma c Manual Cleaner Endozime AW Plus PowerCon Triple Ge nge Clean Aniosyme Synergy 5 Endozime Xtreme Power Endozime AW Triple Plus 6

7 Agitated Immersion Test: % Removal of Fatty Soil from a Stainless Steel Surface in 3 minutes at 50 C (122 F) by Enzymatic Detergent Products (only brand names shown) Untreated Tap Water Control Prolystica HP Enzymatic Manual Cleaner Endozime AW Triple Plus 7

8 8 PowerCon Triple Getinge Clean Enymatic Aniosyme Synergy 5 Endozime Xtreme Power

9 Endozime AW Triple Plus 9

10 Method 3: Evaluation of Synthetic Surgical Soil Cleaning Using Blood/Bone/Fat/Tissue Prolystica HP Enzymatic Manual Cleaner had greater than 98% removal of soil after 10 minutes with no visible soil residue. The next closest competitor was Aniosyme Synergy 5 Enzyme Detergent which achieved 91.5% soil removal, yet left large pieces of soil adhering to the hemostats. Endozime AW Plus Enzymatic Detergent, PowerCon Triple Enzyme Detergent Concentrate, and Getinge Clean Enzymatic Detergent had percent soil removals of approximately 90%. Endozime AW Triple Plus with A.P.A. Multi-Tiered Enzymatic Detergent and Endozime Xtreme Power Multi-Tiered Enzymatic Detergent had percent soil removals of only 85% and 83% respectively with all the hemostats remaining heavily soiled in appearance Agitated Immersion Test: % Removal of Blood/Bone/Tissue/Fat Soil in 10 minutes at 50 C (122 F) by Enzyma c Detergent Products (only brand names shown) % Removal Tap Water Control Prolys ca HP Enzyma c Manual Cleaner Aniosyme Synergy 5 Endozime AW Plus PowerCon Triple Enzyme Ge nge Clean Endozime AW Triple Plus Endozime Xtreme 10

11 Agitated Immersion Test: % Removal of Blood/Bone/Tissue/Fat Soil in 10 minutes at 50 C (122 F)by Enzymatic Detergent Products (only brand names shown) Untreated Tap Water Control 11

12 Prolystica HP Enzymatic Manual Cleaner Aniosyme Synergy 5 12

13 Endozime AW Plus PowerCon Triple Enzyme 13

14 Getinge Clean Enymatic Endozime AW Triple Plus 14

15 Endozime Xtreme 15

16 5Conclusion Prolystica HP Enzymatic Manual Cleaner is effective against a variety of soils, including protein, fat, bone chip, and tissue soils. This neutral ph enzymatic cleaner removes all soils quickly and completely. No competitor s product was able to attain either the effectiveness of cleaning or the speed of cleaning demonstrated by Prolystica HP Enzymatic Manual Cleaner on all soils, even when used at up to 4 times the concentration. REFERENCES: 1. Prolystica is a registered trademark of STERIS Corporation 2. Crisco is a registered trademark of The J.M. Smucker Company 3. Aniosyme Synergy 5 Enzyme Detergent is a product of Laboratories Anios 4. Endozime and AW Triple Plus are registered trademarks of The Ruhof Corporation 5. PowerCon is a trademark of Getinge USA Inc. 6. Getinge Clean Enzymatic Detergent is distributed by Getinge Group Document # Rev. B 2018 STERIS Corporation All Rights Reserved 16 STERIS Corporation 5960 Heisley Road Mentor, OH USA