Technical Data Monograph

Transcription

1 Technical Data Monograph Compatibility of Prolystica 2X Concentrate Presoak and Cleaner and Other Products with Soft Metal Substrates

2 Table of Contents 1. Purpose Methods Results Conclusion

3 1Purpose Prolystica 2X Concentrate Presoak and Cleaner is a concentrated, liquid detergent designed for use in manual cleaning and automatic washers/disinfectors for the processing of surgical instruments. The product has exceptional protein and lipid cleaning capabilities. The purpose of this study is to compare the compatibility of Prolystica 2X Concentrate Presoak and Cleaner and eight additional enzymatic products with two representative soft metal substrates commonly used in the manufacture of surgical instruments, utensils, trays, and medical devices. 2Methods Prolystica 2X Concentrate Presoak and Cleaner (STERIS Corporation), Asepti-Zyme Instrument Presoak and Cleaner (Huntington brand, Ecolab ), Rapid-Zyme Instrument Presoak and Cleaner (Huntington brand, Ecolab) OptiPro Multi- Low Foaming (Ecolab), V. Mueller Dual Enzy-Clean Low Suds Pre-Soak and (Cardinal Health), MetriZyme Dual (Metrex), Tri-Power TM Cleaner (United Biotech TM, Inc.), Ecozyme TM Ultra Concentrate (Pro-Line Solutions, Inc.), ProClean Instrument (Stryker ), PowerCon Triple Enzyme Concentrate (Getinge USA, Inc.), Medline & Pre-Soak (Medline Industries, Inc.), SuperNova.25 Multi- Cleaner (Case Medical, Inc. ), and Enzol (ASP ) were tested for compatibility with four soft metal substrates. Coupons representing aluminum, anodized aluminum, copper, and brass were used in the study. The substrate compatibility was evaluated by determining the corrosion rate of the given metal substrate. This corrosion rate was based on weight loss expressed as millionths of an inch (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 alone 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. Coupons demonstrating a visual effect were acid washed to remove any corrosion deposits in order to calculate an accurate mpy. 3Results Visual inspection of the aluminum and brass coupons immersed in Prolystica 2X Concentrate Presoak and Cleaner revealed no negative effects. The very slight darkening seen on the aluminum coupons was significantly less than the tap water control, and the corrosion rate was only slightly higher than one mpy and similar to water. There was very slight hue change for brass; however, the mpy was less than 1mpy. Visual inspection of the aluminum coupons revealed that exposure to the remaining eight products all caused some level of discolor- 1

4 ation. V. Mueller Dual Enzy-Clean, Medline and Medline Dual demonstrated significant darkening with heavy staining to a much greater degree than tap water (control). SuperNova.25, PowerCon Triple Enzyme, Asepti-Zyme, OptiPro, Enzol and Rapid-Zyme caused discoloration comparable to tap water. Medline and V. Mueller Dual Enzy-Clean both had corrosion rates of greater than two mpy and significantly worse than tap water (control). Ecozyme displayed a small amount of mild blue/purple coloration around both ends of the coupons. Visual inspection of the brass coupons immersed in Asepti-Zyme and Rapid-Zyme, revealed dark, even discoloration. Stryker ProClean had dark and uneven discoloration. V. Mueller Dual Enzy-Clean, Medline and Medline Dual caused extremely heavy, iridescent staining and blackening, and both had corrosion rates of greater than one mpy and the tap water control. Enzol had heavy discoloration with iridescent staining. Substrate Compatibility 48 hrs, 50 C Aluminum 1100 Dry Control Tap Water Control SuperNova.25 Multi- Cleaner Powercon Triple Enzyme Concentrate Asepti-Zyme Rapid-zyme V. Mueller Dual Enzy-Clean Medline and Presoak Prolystica 2X Concentrate Presoak and Cleaner Medline Dual & Presoak Ecolab OptiPro Multi- Low Foaming Enzol EcoZyme Ultra Concentrate 2

5 Brass CDA 443 Dry Control Tap Water Control Asepti-Zyme Rapid-Zyme V. Mueller Dual Enzy-Clean Medline and Presoak Prolystica 2X Concentrate Presoak and Cleaner Stryker ProClean Instrument Medline Dual & Presoak Enzol *All are averages of 3 except Prolystica and tap water are an average of 6. Substrate evaluated in 2X the highest dilution Prolystica 2X Concentrate Presoak and Cleaner (STERIS) 1 oz/gal Tap Water Control Powercon Triple Enzyme Concentrate (Getinge) ½ oz/gal OptiPro Multi- Low Foaming (Ecolab) ProClean Instrument (Stryker) 4 oz/gal mpy mpy mpy mpy mpy AL std dev observations Very slightly Discolored with Discolored Darkening of coupon No Change darkened white spots CDA 443 (brass) std dev Observations Very slight hue change No Change No Change No Change Darkened Substrate evaluated in 2X the highest dilution Medline (Medline) V. Mueller Dual Enzy-Clean (Cardinal Health) Asepti-Zyme Instrument Presoak and Cleaner (Ecolab) Rapid-Zyme Instrument Presoak and Cleaner (Ecolab) Super Nova.25 (Case Medical) 1/ mpy mpy mpy mpy mpy AL std dev observations Darkened with Darkened with Discolored Discolored Discolored heavy staining heavy staining CDA 443 (brass) std dev observations Heavy iridescent staining Heavy iridescent staining Darkened Slightly discolored No Change 3

6 Substrate evaluated in 2X the highest dilution Medline Dual and Pre-Soak (Medline) 4 oz/gal Metrizyme Dual (Metrex) Eco-Zyme Multi- Ultra Concentrate (Pro-Line Solutions, Inc.) Tri-Power Cleaner (United Biotech) Enzol (ASP) 1 oz/gal mpy mpy mpy mpy mpy AL std dev observations Darkening of coupon No Change Mild blue/purple No Change Slight darkening around ends CDA 443 (brass) std dev observations Heavy green/blue coloring; iridescent No Change No Change Slightly discolored Dramatic purple/ gold coloring; iridescent 4Conclusion Under the exaggerated time and temperature conditions of this study, Prolystica 2X Concentrate Presoak and Cleaner appeared to have good substrate compatibility with the two representative soft metal substrates. V. Mueller Dual Enzy-Clean, Stryker ProClean, Enzol, Asepti-Zyme, Medline and Medline Dual appear to be incompatible with brass. Almost all competitive products appeared to have some degree of incompatibility with aluminum, especially V. Mueller Dual Enzy-Clean, Medline, and Ecolab OptiPro Multi-, with the exception of Stryker ProClean, Metrizyme Dual, and Tri-Power. References: Research and Development Notebook numbers: Data on file. 4

7 Document #M3923EN , Rev. A 2013 STERIS Corporation. All rights reserved. STERIS Corporation 5960 Heisley Road Mentor, OH n USA n