Compatibility of Prolystica® Enzymatic Presoak and Cleaner and other Enzymatic Products with Soft Metal Substrates

Technical Data Monograph

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Table of ContentsPurpose.......................................................................................................................................................2Methods.........................................................................................................................................................2Results...........................................................................................................................................................2Conclusion....................................................................................................................................................4

Purpose

Prolystica® Enzymatic 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 was to compare the compatibility of Prolystica Enzymatic 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.

Methods

Prolystica Enzymatic Presoak and Cleaner (STERIS® Corporation), Asepti-zyme™ Instrument Presoak and Cleaner (Huntington® brand, Ecolab®), Rapid-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 Triple PLUS (The Ruhof Corporation), Endozime® SLR (The Ruhof Corporation), Medline Enzymatic Detergent and PreSoak (Medline Industries, Inc.) and SuperNova .25 Multi-Enzymatic Cleaner (Case Medical, Inc.®) were tested for compatibility with two soft metal substrates. Coupons representing aluminum and brass were used in the study.

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 were acid washed to remove any corrosion deposits.

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 mils per year (mpy) after 48 hours at 50˚C in static immersion in a product dilution of two times the highest concentration recommended on the label, up to a maximum of two ounces/gallon (except for Endozime SLR that has a label use of 1:10). The higher the corrosion rate, the more corrosive the product dilution is to the metal. Therefore, a low corrosion rate (less than one mpy), is desirable.

Results

Visual inspection of the aluminum and brass coupons immersed in Prolystica Enzymatic Presoak and Cleaner revealed no negative effects. The 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 tap water. There was very slight hue change for brass; however, the mpy was less than one mpy.

Visual inspection of the aluminum coupons revealed that exposure to the remaining eight products all caused some level of discoloration. V. Mueller Dual Enzy-Clean and Medline Enzymatic demonstrated significant darkening with heavy staining to a much greater degree than tap water (control). SuperNova.25, Endozime AW Triple Plus, Endozime SLR, PowerCon Triple Enzyme, Asepti-zyme and Rapid-zyme caused discoloration comparable to tap water. Medline Enzymatic and V. Mueller Dual Enzy-Clean both had corrosion rates of greater than two mpy and significantly worse than tap water (control).

Visual inspection of the brass coupons immersed in Asepti-zyme, Rapid-zyme and Endozime SLR revealed dark, even discoloration. V. Mueller Dual Enzy-Clean and Medline Enzymatic caused extremely heavy, iridescent staining and blackening and both had corrosion rates of greater than one mpy and the tap water (control).

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3

Substrate Compatibility 48 hrs 50°C

Aluminum 1100

Brass CDA 443

Dry Control

Tap Water Control

Endozime® SLR

SuperNova .25 Multi-Enzymatic Cleaner

Powercon® Triple Enzyme Detergent Concentrate

Endozime® AW Triple Plus

Asepti-zyme™

Rapid-zyme™

V. Mueller® Dual Enzy-Clean®

Medline Enzymatic Detergent and Presoak

Prolystica® Enzymatic Presoak and Cleaner

Dry Control

Tap Water Control

Asepti-zyme™

Rapid-zyme™

Endozime® SLR

V. Mueller® Dual Enzy-Clean® Medline Enzymatic Detergent and Presoak

Prolystica Enzymatic Presoak and Cleaner

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Conclusion

Under the exaggerated time and temperature conditions of this study, Prolystica Enzymatic Presoak and Cleaner appeared to have good substrate compatibility with both of the two representative soft metal substrates. V. Mueller Dual Enzy-Clean and Medline Enzymatic appear to be incompatible with brass. All competitive products appeared to have some degree of incompatibility with aluminum, especially V. Mueller Dual Enzy-Clean and Medline Enzymatic.

References: Research and Development Notebook numbers:6484: 56-64

Substrate 2X the highest dilution up to a maximum of 2 oz/gal

Prolystica Enzymatic Presoak and Cleaner (Steris) 1 oz/gal

Tap Water Control

PowerCon Triple Enzyme Concentrate (Gentinge) 1/2 oz/gal

Endozime SLR (Ruhof) 1:10

Endozime AW Triple Plus (Ruhof)1 oz/gal

mpy mpy mpy mpy mpy

AL1100 1.40 0.70 0.08 0.16 -0.33

Standard deviation 0.14 0.47 0.31 0.26 0.26

Observations Very slightly darkened

Discolored with white spots

Discolored Staining with pitting

Discolored

CDA 443 (brass) 0.13 0.10 0.24 0.51 0.12

Standard deviation 0.13 0.27 0.25 0.11 0.14

observations Very slight hue change

No Change No Change Darkened No Change

Substrate 2X the highest dilution up to a maximum of 2 oz/gal

V. Mueller Dual Enzy-Clean (Cardinal Health) 2 oz/gal

Medline Enzymatic (Medline) 2 oz/gal

Asepti-zyme Instrument Presoak and Cleaner (Ecolab) 2 oz/gal

Rapid-zyme Instrument Presoak and Cleaner (Ecolab) 2 oz/gal

Super Nova .25Multi-Enzymatic Cleaner (Case Medical) 1/2 oz/gal

mpy mpy mpy mpy mpy

AL1100 2.84 2.84 0.04 0.29 0.08

Standard deviation 0.33 0.54 0.07 0.28 0.26

Observations Darkened with heavy staining

Darkened with heavy staining

Discolored Discolored Discolored

CDA 443 (brass) 1.29 1.05 0.12 0.04 0.25

Standard deviation 0.22 0.28 0.09 0.16 0.28

observations Heavy iridescent staining

Heavy iridescent staining

Darkened Slightly discolored

No Change

STERIS Corporation5960 Heisley RoadMentor, OH 44060-1834 n USA440-354-2600 n 800-548-4873www.steris.com

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Document # M3243EN.2009-04, Rev. APrinted 04/2009, 1000

©2009 STERIS Corporation. All rights reserved. Printed in USA.

Technologies to Prevent Infection and Contamination™

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