TECHNICAL MONOGRAPH. Vaprox Hydrogen Peroxide Sterilant

Table of Contents 1. Introduction 3 2. Description 3 3. Principles of Use 3 4. Consumables 4 a. Vaprox Hydrogen Peroxide Sterilant 5. Performance Evaluation 4 a. Food Chemical Codex 4 b. Shelf-Life (Un-Opened Containers) 4 c. In-Use (Open Containers - 950mL Cartridges) 5 d. In-Use (Open Containers - 18.9L Cartridges) 6 e. Stability of Un-Opened Containers 7 (18 months @ 4 C, 25 C, 40 C) f. Stability of Un-Opened Containers 8 (2 weeks @ 49 C and 17.5 months @ 4 C, 25 C, 40 C) 6. Other Characteristics 11 a. Aqueous Solution 11 b. Endotoxin 11 c. Residual Solvents 11 d. Organic Materials 11

1. Introduction This Technical Monograph (TM) illustrates the principles of Vaprox Hydrogen Peroxide Sterilant and guidance as to its effective use. Vaprox is intended for use with STERIS VHP Biodecontamination Units in biodecontamination 1 of clean, dry, sealed Enclosures 2. 1 In this document, when referring to the use of VHP Biodecontamination Units with Vaprox Hydrogen Peroxide Sterilant in the United States of America (USA), the term Biodecontamination is defined as sterilization of exposed porous and non-porous surfaces in a pre-cleaned, dry, sealed Enclosure. Any reference to Biodecontamination pertaining to the use of this equipment in the United States does not, and is not intended to convey additional claims of effectiveness beyond those contained in the USA Environmental Protection Agency (EPA) registered labeling of Vaprox Hydrogen Peroxide Sterilant (EPA Reg. No. 58779-4). 2 Contained area to be Biodecontaminated (e.g., rooms, facilities and equipment). 2. Description Vaprox Hydrogen Peroxide Sterilant is a specially formulated, stabilized, high-purity, 35% aqueous hydrogen peroxide solution. Other characteristics are as follows: Demonstrates broad-spectrum efficacy against viruses, bacteria, yeasts and bacterial spores Compatible with a wide range of materials (including metals, plastics and optics) Ensures biodecontamination of environmental surfaces with no toxic residue Label includes directions for use, safety information, lot number, expiration date and reorder number Package insert is shipped with each lot Safety Sheet (SDS) and Certificate of Analysis are available 24/7 at www.sterislifesciences.com Governed by two expiration dates: Shelf Life and In-Use Produced under controlled conditions to assure effectiveness through expiration date stamped on label. 3. Principles of Use STERIS s VHP Process Technology produces hydrogen peroxide vapor from liquid Vaprox Hydrogen Peroxide Sterilant and disperses this vapor throughout the enclosure without condensation of the active ingredient onto surfaces. The Biodecontamination Cycle is conducted per the Fumigation Management Plan (FMP). NOTE: STERIS Biodecontamination Units are only to be operated by Trained and Certified Applicators who have successfully completed both the STERIS Training and Certification Course for Applicators of Vaprox Hydrogen Peroxide Sterilant and the pertinent Biodecontamination Unit Operator Course. Certification must be active and in force for all Applicators of Vaprox Hydrogen Peroxide Sterilant. (www.vaproxtraining.com)

4. Consumables Vaprox Hydrogen Peroxide Sterilant 35% stabilized aqueous solution of hydrogen peroxide designed for use with VHP Biodecontamination Units and Accessories (EPA Reg. No. 58779-4). 5. Performance Evaluation Food Chemical Codex (FCC) Compliance Table 1. Food Chemical Codex Standards Test Name Method Number FCC Vaprox H2O2 Concentration (% by wt) M915393 32.5-37.5 Aproximate ph M915502 2.5-4.5 Physical State N/A Liquid 24-Hour Stability Manufacturer CofA 96 Residue (After Evaporation) (ppm)* Manufacturer CofA 60 60 Acidity (as H2SO4)(%)* M915493 0.03 0.03 Iron (ppm)* Manufacturer CofA 0.5 0.5 Tin (ppm)* Manufacturer CofA 10 10 Phosphate (ppm)* Manufacturer CofA 50 50 Lead (ppm)* Manufacturer CofA 4 4 Vaprox complies with FCC standards for use in FDA applications for aseptic food packaging (21 CFR 178.1005). Shelf-Life (Un-Opened Containers) Procedure 3 Lots of Vaprox 950mL containers were sampled at regular intervals (0, 3, 6, 9, 12, 18, and 24 months) over the course of 24 months. Temperature: 25 C Test Specification: 32.5 37.5% (w/w)

Table 2. 24-Month Stability Study @ 25 C Lot 1 0 3 6 9 12 18 24 35.6 35.4 35.2 35.2 35.3 36.0 35.0 %H2O2 35.6 35.5 35.8 35.2 35.4 35.4 34.9 35.5 AVG 35.6 35.5 35.5 35.2 35.4 35.7 35.0 Lot 2 0 3 6 9 12 18 24 35.4 35.2 35.1 35.2 35.2 35.1 34.9 %H2O2 35.4 35.3 35.1 35.2 35.0 35.3 35.0 35.4 AVG 35.4 35.3 35.1 35.2 35.1 35.2 35.0 Lot 3 0 3 6 9 12 18 24 35.5 35.3 35.1 35.2 35.1 35.1 34.9 %H2O2 35.4 35.3 35.2 35.3 35.1 35.3 34.9 35.4 AVG 35.4 35.3 35.2 35.3 35.1 35.2 34.9 No significant changes were noted in color and clarity. Vaprox complies with the required specifications of 32.5 37.5% for the 24- month stability study. Recommended shelf-life for 950mL, 18.9L, and 200,6L un-opened containers is 24- months when stored in accordance with Vaprox Package Label and MSDS storage conditions. In-Use (Open Containers - 950mL Cartridges) Procedure Vaprox 950mL containers were filled to four different fill volumes (100, 200, 400, and 800mL) and sampled at regular intervals (0, 15, 30, and 60 days) over the course of 60 days. Temperature: 25 C

Table 3. 60-Day Stability Study @ 25 C AVG Days ml 0 15 30 60 100 35.0 34.8 34.8 34.7 200 34.9 34.8 34.8 34.7 400 35.0 34.9 34.9 34.8 800 34.9 34.9 34.9 34.8 No significant changes were noted in color and clarity. Vaprox complies with the required specifications of 32.5 37.5% for the 60-day stability study. Recommended shelf-life for opened 950mL containers is 60-days when stored in accordance with Vaprox Package Label and MSDS storage conditions. In-Use (Open Containers - 18.9L Pails) Procedure Vaprox 18.9L containers were sampled at regular intervals (0, 1, 2, 3, and 6 months) over the course of 6-months. Temperature: 25 C Table 4. 6-Month Stability Study @ 25 C 0 1 2 3 6 35.0 35.1 35.9 35.1 34.9 34.9 35.1 35.2 35.1 35.0 35.0 35.0 35.1 AVG 35.0 35.1 35.6 35.1 35.0 No significant changes were noted in color and clarity. Vaprox complies with the required specifications of 32.5 37.5% for the 60-day stability study. Recommended shelf-life for opened 18.9L and 200.6 containers is 6-months when stored in accordance with Vaprox Package Label and MSDS storage conditions.

Stability of Un-Opened Containers (18 months @ 4 C, 25 C, 40 C) Procedure Un-cleaned containers were used to simulate a worst case condition. Vaprox 950mL containers were filled and sampled at regular intervals (0, 3, 6, 9, 12 and 18 months) over the course of 18 months. Temperature: 4 C, 25 C, 40 C Test Specification: 32.5 37.5% (w/w) Table 5. 18-Month Stability Study @ 4 C 0 3 6 9 12 18 34.9 35.1 35.0 35.4 35.0 34.9 35.2 35.1 35.0 35.1 35.1 35.1 35.0 35.1 35.0 35.3 35.1 35.0 35.1 34.9 35.0 35.3 35.4 34.9 35.0 34.9 35.0 35.3 35.2 35.0 35.1 35.0 35.0 35.2 35.1 34.9 35.1 35.0 35.0 35.3 35.2 35.1 35.1 35.0 35.1 35.2 35.1 35.1 35.1 34.9 34.9 35.2 35.1 35.0 35.1 35.1 35.1 35.4 35.2 34.7 AVG 35.1 35.0 35.0 35.3 35.1 35.0 Table 6. 18-Month Stability Study @ 25 C 0 3 6 9 12 18 35.1 34.9 34.9 35.0 34.6 34.7 35.0 34.9 34.8 35.0 35.0 34.7 35.0 35.1 34.9 35.0 34.6 34.5 35.0 35.0 34.9 34.8 35.0 34.7 35.0 35.1 34.9 34.9 35.0 34.5 35.1 35.0 34.9 35.0 35.0 34.7 35.1 35.1 35.0 35.1 35.1 34.7 35.1 34.9 35.0 34.9 35.0 34.6 35.0 35.0 35.0 35.0 35.0 34.6 35.0 34.9 34.9 35.2 34.7 34.6 AVG 35.0 35.0 34.9 35.0 34.9 34.6

Table 7. 18-Month Stability Study @ 40 C 0 3 6 9 12 18 35.2 34.9 34.6 34.6 34.5 33.8 35.1 34.8 34.6 34.6 34.6 33.9 35.1 34.7 34.7 34.7 34.4 34.0 35.0 34.9 34.6 34.6 34.3 33.9 35.1 34.9 34.6 34.5 34.4 34.1 35.1 34.7 34.6 34.6 34.4 34.0 35.1 34.8 34.6 34.7 34.3 33.9 35.2 34.8 34.5 34.7 34.4 33.8 35.1 35.0 34.5 34.7 34.5 34.0 35.1 34.9 34.5 34.6 34.6 33.9 AVG 35.1 34.8 34.6 34.6 34.4 33.9 Stability study intended to simulate worst case conditions. No significant changes were noted in color and clarity. Vaprox complies with the required specifications of 32.5 37.5% for the 18- month stability study. Stability of Un-Opened Containers (2 weeks @ 49 C and 17.5 months @ 4 C, 25 C, 40 C) Procedure Un-cleaned containers were used to simulate a worst case condition. Vaprox 950mL containers were filled and sampled at regular intervals (0, 2 weeks, 3, 6, 9, 12 and 18 months) over the course of 18 months. Temperature: 49 C for 2 weeks then 17.5 months @ 4 C, 25 C, 40 C Test Specification: 32.5 37.5% (w/w)

Table 8. 18-Month Stability Study @ 4 C 0 0.5 3 6 9 12 18 35.1 35.0 35.0 34.9 35.2 35.2 35.0 35.0 35.0 35.0 34.9 35.2 35.2 34.9 35.0 34.9 35.0 35.1 35.2 35.3 34.8 35.1 35.0 35.0 34.9 35.2 35.3 35.1 35.0 34.9 35.0 34.8 35.2 35.3 34.9 35.1 34.9 35.1 34.8 35.0 35.3 35.0 35.1 35.2 34.9 35.1 35.0 35.3 34.9 35.0 35.0 35.0 34.9 35.1 35.3 35.0 35.1 35.0 35.0 34.9 35.0 35.0 35.0 35.1 35.0 35.0 34.9 34.9 35.0 34.9 AVG 35.0 35.0 35.0 34.9 35.1 35.2 34.9 Table 9. 18-Month Stability Study @ 25 C 0 0.5 3 6 9 12 18 35.1 35.1 34.9 34.9 35.1 34.8 34.7 35.1 35.0 34.8 34.8 34.9 34.9 64.6 35.2 35.0 34.8 34.9 35.1 35.1 34.6 35.2 35.0 34.9 34.8 35.0 35.0 34.7 34.9 35.0 34.8 34.9 34.9 34.8 34.3 34.9 35.1 35.0 34.8 35.1 34.8 34.8 35.0 35.0 34.9 34.9 35.2 35.1 34.6 35.2 35.1 34.9 34.8 34.9 35.0 34.7 35.0 35.0 34.9 34.9 35.0 34.8 34.6 35.1 34.9 34.9 34.9 35.2 35.0 34.5 AVG 35.1 35.0 34.9 34.8 35.0 34.9 37.6 Table 10. 18-Month Stability Study @ 40 C 0 0.5 3 6 9 12 18 35.1 35.1 34.9 34.7 34.8 34.3 34.3 35.0 35.2 34.9 34.6 34.6 34.4 34.0 35.1 35.0 34.8 34.7 34.6 34.3 33.8 35.1 35.0 34.8 34.9 34.5 34.5 34.1 35.1 34.8 34.8 34.7 34.6 34.4 33.8 35.2 35.1 34.7 34.8 34.6 34.4 34.0 35.2 35.0 34.7 34.5 34.5 34.5 34.1 35.1 35.2 34.8 34.6 34.5 34.4 34.0 35.1 35.0 34.9 34.5 34.6 34.3 33.8 35.0 35.0 34.8 34.5 34.5 34.5 33.9 AVG 35.1 35.0 34.8 34.6 34.6 34.4 34.0

Stability study intended to simulate worst case conditions for shipping. No significant changes were noted in color and clarity. Vaprox complies with the required specifications of 32.5 37.5% for the 18- month stability study.

6. Other Characteristics Aqueous Solution Vaprox is an aqueous solution comprised of 35% inorganic hydrogen peroxide and 65% de-mineralized water. Endotoxin Table 11. Endotoxin Sample PPC Dilution Result 14071421 62% 1:20 < 0.20 EU/mL 14071422 67% 1:20 < 0.20 EU/mL 14071423 70% 1:20 < 0.20 EU/mL "<" denotes below detection limit Report was generated by BioTest Laboratories. Residual Solvents The manufacturing process for Vaprox may contain the following residual solvents: Methanol Class 2 < 5ppm Tetralin Class 2 < 1ppm Acetic Acid Class 3 < 5ppm Acetone Class 3 < 5ppm Organic Materials Vaprox contains only inorganic materials. Vaprox does not contain: Latex Genetically Modified Organisms (GMO) Catalysts Any ingredients derived from Animal Origin.