Biological Safety Assessment of Steri-7 Worldwide Biocide

Purpose

This document is intended to identify biological testing requirements and to evaluate the risks (if any) of the testing program for Steri-7 Worldwide biocide solution currently sold under the trade name Steri-7.

This document examines the probability that this biocide would cause a biological reaction during use and not be biocompatible with the body. This includes biological reactions such as acute toxicity and localized tissue reactions as irritation.

This document also examines the probability of a biological reaction in humans from food processed or packaged in areas primarily cleaned or disinfected width Steri-7.

This risk management document is based on ISO 14971:2000(E), Medical devices – Application of risk management to medical devices.

Risk Analysis

The risk analysis is conducted with the assumption that this material is to be used as a broad spectrum cleaner and surface sterilizer for clinics, hospitals, restaurants, and dental, doctor and veterinary offices.

Its intended use is currently designated for cleaning and disinfection of surfaces.

Physiochemical Properties – Steri-7TM is an advanced biocidal cleaner that remains active even when dry. A single application is reported to kill micro-organisms in seconds and prevents further contamination or recolonization for 7 days. The following table lists the various ingredients (Sentinel MSDS) in Steri-7.

Efficacy Testing - Steri-7

A number of BS EN Clinical tests performed by MGS Laboratories have shown that Steri-7™ remains 100% active for at least 7 days and is a broad spectrum biocide providing protection against many dangerous micro-organism, including Methicillin-resistant Staphylococcus aureus (MRSA), E. coli, Legionella pneumophila, and Salmonella enteritidis. These studies were able to demonstrate that Steri-7TM was just as effective at killing bacteria when applied wet and for up to 7 days when dry.