Technical Data Monograph. Compatibility of Prolystica Ultra Concentrate Enzymatic Cleaner and Other Enzymatic Products with Soft Metal Substrates

Transcription

1 Technical Data Monograph Compatibility of Prolystica Ultra Concentrate Enzymatic Cleaner and Other Enzymatic Products with Soft Metal Substrates

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3 Table of Contents Purpose Method Results Substrate Compatibility Conclusion

4 Purpose Prolystica Ultra Concentrate Enzymatic Cleaner is a concentrated, liquid, dual proteolytic detergent designed for use in automatic washers/disinfectors for the processing of surgical instruments. The purpose of this study was to compare the compatibility of Prolystica Ultra Concentrate Enzymatic Cleaner and nine additional enzymatic products with four soft metal substrates commonly used in the manufacture of surgical instruments, utensils, trays, and medical devices. Methods Prolystica Ultra Concentrate Enzymatic Cleaner (STERIS Corporation), Asepti-Solid Enzyme (Huntington brand, Ecolab ), Asepti-Zyme Instrument Presoak and Cleaner (Huntington brand, Ecolab ), V. Mueller Dual Enzy-Clean Low Suds Enzymatic Pre-Soak and Detergent (Cardinal Health), PowerCon Triple Enzyme Detergent Concentrate (Getinge USA, Inc.), Endozime AW PLUS (The Ruhof Corporation), Medline Enzymatic Detergent & Pre-Soak (Medline Industries, Inc.), dual enzymatic detergent (Metrex Research Corporation), SuperNova.25 Multi-Enzymatic Cleaner (Case Medical, Inc. ), and AVENACLEAN 888 ph-neutral detergent (Belimed, Inc.) were tested for compatibility with four soft metal substrates. Coupons representing aluminum, anodized aluminum, brass, and copper were used in the study. The substrate compatibility was evaluated by determining the corrosion rate of a given metal substrate. This corrosion rate was based on weight loss expressed as mils per year (mpy) after 48 hours at 50 C in static immersion in a product dilution of 2x the highest concentration recommended on the label, up to a maximum of two ounces/gallon. The higher the corrosion rate, the more corrosive the product dilution is to the metal. A low corrosion rate (less than one mpy), therefore, is desirable. To simulate worst-case conditions and effects that might only be apparent over extended time periods, the exposure time and temperature were exaggerated to maximize effects. The coupons were cleaned, air dried, and desiccated. The coupons were weighed before and after exposure, and the corrosion rate was calculated based on weight loss data. The coupons were also visually examined for any signs of corrosion or pitting. Coupons were also exposed to a tap water control under the same test conditions. The control was used to distinguish between the corrosive effects of water versus the effects of the detergent product, and to evaluate the detergent s ability to provide protection from that corrosive water effect. Results Visual inspection of the anodized aluminum, brass, and copper metallic coupons immersed in Prolystica Ultra Concentrate Enzymatic Cleaner revealed no negative effects. The corrosion rates were less than one mpy. The slight discoloration seen on the aluminum coupons was significantly less than the tap water control, and the corrosion rate remained less than one mpy. Visual inspection of the aluminum coupons revealed that exposure to the remaining nine products all caused some level of discoloration. Asepti-Zyme, AVENACLEAN, Medline Enzymatic, and demonstrated significant discoloration but to a lesser degree than tap water (control). SuperNova.25, Endozime, PowerCon Triple Enzyme, and V. Mueller Dual Enzy-Clean caused discoloration comparable to tap water. Asepti-Solid Enzyme caused discoloration to a greater degree than tap water. Medline Enzymatic,, and AVENACLEAN all had corrosion rates of greater than two mpy, significantly worse versus tap water (control). Visual inspection of the anodized aluminum coupons revealed that Medline Enzymatic,, and AVENACLEAN caused a dull finish, and had corrosion rates of greater than seven mpy. Both visual results and corrosion rates were much worse than tap water (control). Visual inspection of the brass coupons immersed in Asepti-Zyme and AVENACLEAN revealed dark, even discoloration. and Medline Enzymatic caused extremely heavy staining and blackening, and Medline Enzymatic had a corrosion rate of greater than one mpy. Results for all four products were worse than tap water (control). Visual inspection of the copper coupons revealed that V. Mueller Dual Enzy-Clean and Asepti-Zyme caused light discoloration as compared to the tap water control. and Medline Enzymatic caused dark discoloration, and PowerCon Triple Enzyme caused heavy staining, leading all three products to be classified as worse than tap water (control). 1

5 Substrate Compatibility 48 hrs, 50 C Aluminum 1100 Prolystica Enzymatic SuperNova.25 (Case Medical) Endozime AW PLUS (Ruhof) PowerCon Triple Enzyme (Getinge) V. Mueller Dual Enzy-Clean (Cardinal Health) Asepti-Solid Enzyme (Huntington/Ecolab) Tap Water (Control) Asepti-Zyme (Huntington/Ecolab) AVENACLEAN 888 (Belimed) (Metrex) Medline Enzymatic (Medline) Brass CDA 443 Copper CDA 110 Prolystica Enzymatic Asepti-Zyme (Huntington/Ecolab) AVENACLEAN 888 (Belimed) (Metrex) Medline Enzymatic (Medline) Prolystica Enzymatic V. Mueller Dual Enzy-Clean (Cardinal Health) Asepti-Zyme (Huntington/Ecolab) (Metrex) Medline Enzymatic (Medline) PowerCon Triple Enzyme (Getinge) Anodized Aluminum 1100 Prolystica Enzymatic AVENACLEAN 888 (Belimed) Medline Enzymatic (Medline) (Metrex) 2

6 Conclusion Under the exaggerated time and temperature conditions of this study, Prolystica Ultra Concentrate Enzymatic Cleaner appeared to have good substrate compatibility with all of the soft metal substrates. V. Mueller Dual Enzy-Clean and PowerCon Triple Enzyme appeared to be incompatible copper, while AVENACLEAN appeared to be incompatible with brass. Asepti-Zyme,, and Medline Enzymatic appeared to be incompatible with both copper and brass. All competitive products appeared to have some degree of incompatibility with aluminum (worse than tap water), especially SuperNova.25 Multi-Enzymatic, Endozime AW PLUS, PowerCon Triple Enzyme, V. Mueller Dual Enzy-Clean, and Asepti-Solid Enzyme. References: Research and Development Notebook numbers: 6285: 35-38, 40-41, 57-66, 68, Substrate Prolystica Enzyme 2/10 oz/ gal Asepti-Solid Enzyme (Huntington/ Ecolab) 2 oz/gal Asepti-Zyme (Huntington/ Ecolab) 2 oz/gal V. Mueller Dual Enzy- Clean (Cardinal Health) 2/8 oz/gal PowerCon Triple Enzyme (Getinge) 2/4 oz/gal Endozime AW PLUS (Ruhof) 2/2 oz/gal mpy mpy mpy mpy mpy mpy AI std dev Observations AI 1100 Anodized Light discoloration overall Darkened with heavy staining Dark discoloration overall Darkened with heavy staining Darkened with heavy staining Darkened with heavy staining std dev Observations Unchanged Unchanged Unchanged Unchanged Unchanged Unchanged CDA 443 (Brass) std dev Observations Unchanged Unchanged Discolored overall Unchanged Unchanged Unchanged CDA 110 (Copper) std dev Observations Unchanged Unchanged Discolored overall Slight discoloration Extremely heavy dark staining Unchanged 3

7 Substrate Medline Enzymatic (Medline) 2 oz/gal (Metrex) 2 oz/gal SuperNova.25 Multi-Enzymatic (Case Medical) 2/4 oz/gal AVENACLEAN (Belimed) 5 ml/l Tap Water mpy mpy mpy mpy mpy AI std dev Observations AI 1100 Anodized Dark discoloration overall Dark discoloration and dull overall Heavily stained Dark discoloration overall Heavy staining with white spots std dev Observations Dull finish Dull finish Unchanged Dull finish Unchanged CDA 443 (Brass) std dev Observations CDA 110 (Copper) Extremely heavy staining Darkened with heavy staining Unchanged Dark discoloration Unchanged std dev Observations Dark discoloration Dark discoloration Unchanged Unchanged Unchanged 4

8 STERIS OFFICES WORLDWIDE Benelux Canada China France Germany India Italy Japan Korea Latin America Malaysia Singapore Spain Sweden Switzerland United Kingdom STERIS Corporation 5960 Heisley Road Mentor, OH n USA n Document # M3099EN , Rev. A GPSI Printed 03/2007, STERIS Corporation. All rights reserved. Printed in USA. Technologies to Prevent Infection and Contamination