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H1N1, Swine Influenza Lab Analysis

Laboratory Results: Swine Flu Analysis

General Study Information

Study Title: Virucidal Efficacy of a Disinfectant for Use on Inanimate Environmental Surfaces
Project Number: A07712
Protocol Number: GRS01042909.SFLU
Testing Facility: ATS Labs
1285 Corporate Center Drive,Suite 110
Eagan,MN 55121

TEST SUBSTANCE IDENTITY

Test Substance EPA No.: 71700-2
Lot/Batch(s): Batch #1: 106-114-1
Batch #2: 106-114-2

Test Substance Characterization

Test substance characterization as to content, stability, solubility, storage, etc., is the responsibility of the sponsor.

STUDY DATES

Date Sample Received: May 1, 2009
Study Initiation Date: May 4, 2009
Experimental Start Date: May 14, 2009
Experimental End Date: May 21, 2009
Study Completion Date: May 26, 2009

OBJECTIVE

The objective of this study was to evaluate the virucidal efficacy of a test substance against Swine Influenza A (H1N1) virus according to test criteria and methods approved by the United States Environmental Protection Agency ( U.S. EPA) for registration of a product as a virucide.

SUMMARY OF RESULTS

Test Substance: EPA Registration # 71700-2 Batch #1: 106114-1 Batch #2: 106-114-2
Dilution: Ready to Use (RTU)
Virus: Swine Influenza A (H1N1) virus, ATCC VR-333,Strain A/Swine/Iowa/15/30
Exposure Time: Ten Minutes
Exposure Temperature: Room Temperature (20°C)
Organic Soil Load: 1% fetal Bovine serum
Efficacy Result: Two batches of 71700-2 (Batch # 1: 106-114-1 and Batch #2: 106-114-2) met the test criteria specified in the study protocol. The results indicate complete inactivation of Swine Influenza A (H1N1) virus under these test conditions as required by the EPA for claims of virucidal activity.

Test System

Virus

The A/Swine/Iowa/15/30/ strain of Swine Influenza A (H1N1) virus used for this study was obtained From the American Type Culture Collection, Manassas, Va (ATCC VR-333). The stock virus was prepared by collecting the supernatant culture fluid from infected culture cells. The cells were disrupted and cell debris removed by centrifugation at approximately 2000 RPM for five minutes at approximately 4° C. The supernatant was removed, aliquoted and the high titer stock virus was stored at -70 degrees until the day of use. On the day of use, an aliquot of stock virus (ATS Labs Lot SF-14) was removed, thawed and maintained at a refrigerated temperature until used in the assay. The stock virus tested demonstrated cytopathic effects (CPE) typical of Influenza virus on Rhesus monkey kidney cells.

Test Cell Cultures

Rhesus monkey kidney (RMK) cells were obtained from ViroMed Laboratories, Inc., Cell Culture Division. Cultures were maintained and used at the appropriate density in tissue culture labware at 36-38° C in a humidified atmosphere of 5-7% CO2. On the day of testing cells were observed as having proper cell integrity and therefore, were acceptable for use in this study.

All cell culture documentation is retained for the cell cultures used in this assay with respect to source, passage number, growth characteristics, seeding densities and the general condition of the cells.

Test Medium

The test medium used in this study was Minimum Essential Meduum (MEM) supplemented with 1 % heat-inactivated fetal bovine serum (FBS), 10 hg/ml gentamicin, 100 units/ml penicillin, and 2.5 hg/ml amphotericin B.

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