GLP VIRUCIDAL TESTING OF ZEROMOLD PLUS FOR HIV-1

Transcription

1 Southwest Research Institute Page 1 of 8 Microencapsulation and Nanomaterials Department Amended Final Report: GLP Virucidal Testing of ZeroMold Plus for HIV-1 Protocol No.: GLP-SP-239 FINAL REPORT STUDY TITLE GLP VIRUCIDAL TESTING OF ZEROMOLD PLUS FOR HIV-1 SwRI STUDY NUMBER GLP-SP-239, Project TEST GUIDELINE OCSPP TESTING FACILITY ATS Labs, Inc. (ATS) 1285 Corporate Center Drive, Suite 110 Eagan, MN Phone: Fax: Southwest Research Institute (SwRI ) Microencapsulation and Nanomaterials Department 6220 Culebra Road San Antonio, Texas , USA Tel: , Fax: SPONSOR BIOSENTA Inc Finch Avenue West, Suite 503 Toronto, Ontario, M3J 3H7 CANADA, Tel: TEST ORGANISM Human Immunodeficiency virus type 1 (HIV-1) TEST PRODUCT IDENTITY ZeroMold Plus (48530, BI#0017-6, Lot #1) ZeroMold Plus (48533, BI# , Lot #2) STUDY DATES Date Sample Received at SwRI: 02/17/2014 Date Sample at LCL Shipped to ATS: 9/26/2014 Study Initiation Date (SwRI): 09/26/2014 Experimental Start Date (ATS): 10/14/2014 Final Experimental End Date (ATS): 10/28/2014 Study End Date (SwRI): 12/19/2014

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5 Southwest Research Institute Page 5 of 8 Microencapsulation and Nanomaterials Department Amended Final Report: GLP Virucidal Testing of ZeroMold Plus for HIV-1 Protocol No.: GLP-SP-239 Table of Contents Page STUDY TITLE... 1 STATEMENT OF NO DATA CONFIDENTIALITY CLAIMS... 2 GLP COMPLIANCE STATEMENT... 3 QUALITY ASSURANCE UNIT STATEMENT OF COMPLIANCE... 4 I. INTRODUCTION... 6 II. TEST SUBSTANCE... 6 III. STUDY PERSONNEL... 6 IV. EXPERIMENTAL METHODS AND RESULTS... 7 HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1, HTLV-III B STRAIN)...7 V. PROCEDURAL MODIFICATIONS/PROTOCOL AMENDMENTS... 7 VI. STUDY CONCLUSIONS... 8 VII. RECORD & SAMPLE RETENTION... 8 VIII. REFERENCES... 8 IX. APPENDIX... 8

6 Southwest Research Institute Page 6 of 8 Microencapsulation and Nanomaterials Department Amended Final Report: GLP Virucidal Testing of ZeroMold Plus for HIV-1 Protocol No.: GLP-SP-239 I. INTRODUCTION BIOSENTA Inc. is interested in assessing its ZeroMold Plus Product as an intermediate and/or low-level disinfectant that kills pathogenic and potentially pathogenic microorganisms on hard non-porous inanimate surfaces or inanimate objects, when used according to labeling. This project provided testing to perform Virucidal Efficacy of a Disinfectant for Use on Inanimate Environmental Surfaces. Testing was performed at ATS Labs at the facility addresses provided in the cover. This lab was previously audited for the Approved Supplier List and has completed the annual qualification review. The project performance is in compliance with EPA's current FIFRA Good Laboratory Practices Standard (40 CFR 160). Amendment #1: The final report was amended to correct several typographical errors. II. TEST SUBSTANCE Test substance information is shown below and active ingredient concentrations provided in Table 1. All ZeroMold Plus product tested was previously titrated and diluted according to the manufacturer s instructions to ensure compliance with EPA guidance on lower certified limit (LCL) (SwRI GLP-SP-210 study). Product Name: ZeroMold Plus Active Ingredient: NaClO Lower Certified Limit (LCL): 0.43% Acceptable Active Ingredient Concentration for Efficacy Testing: 0.43%-0.44% (2% above LCL) Storage Conditions: Ambient Temperature, cap closed (all lots tested) Test Substance Spray Conditions (as follows): Distance = 6-8" Number of pumps = 4 Contact Time = 10 minutes Exposure Temperature = C (room temperature) Organic Soil Load = 5 % Fetal Bovine Serum (FBS) Table 1. Test substance active ingredient concentration (LCL to up to 2% above LCL). ZeroMold Plus Test batch/lot information Active ingredient (NaClO) Concentration/Dilution Tested concentration 48530, Lot #1 (B1#0017-6), >60 days 0.44% 48533, Lot #2 (B1#0018-3), >60 days 0.43% Ready-to-use, Trigger Spray III. STUDY PERSONNEL XingGuo Cheng, Study Director at SwRI Shanen Conway, Study Director at ATS Labs, MN (ATS will provide their personnel details) All study personnel have received training in Good Laboratory Practices standards and are experienced in their area of responsibility. Resumes and training records for these personnel are maintained with SwRI s and ATS s Quality Assurance Unit.

7 Southwest Research Institute Page 7 of 8 Microencapsulation and Nanomaterials Department Amended Final Report: GLP Virucidal Testing of ZeroMold Plus for HIV-1 Protocol No.: GLP-SP-239 IV. EXPERIMENTAL METHODS AND RESULTS The general experimental method for virucide testing is summarized in Figure 1 below. Briefly, virus films were prepared and sprayed with ZeroMold Plus using 4 sprays at a distance of 6-8 inches, at a 45 degree angle and held covered for 10 min. The viruses (live or dead) were separated from the test substance and the absence or presence of infectivity using cell culture was examined. Figure 1 General test procedure for virucidal efficacy test of ZeroMold Plus disinfectant Human Immunodeficiency Virus Type 1 (HIV-1, HTLV-III B strain) The controls and test substance assay results are summarized in Tables 2. Controls and neutralization results are in compliance with the ATS test protocol (SWT HIV) study acceptance criteria. Under the conditions of this investigation and in the presence of 5% fetal bovine serum organic soil load, ZeroMold Plus, ready to use as a trigger spray, demonstrated complete inactivation of HIV-1 following 10 minute exposure at room temperature as required by the U.S. EPA and Health Canada. Table 2 Controls and Test Substance Assay Results (detailed results are shown in Appendix 2) ZeroMold Plus Dried Virus Control Cell Control (MT-2 cells) 2 lots Test substance cytotoxicity No virus infectivity; at 1.5 log 10 Neutralization Control Positive for the presence test virus after lower titer stock virus added Test Substance Cytotoxicity Control No cytotoxicity present Test Substance Assay Results No virus recovered (Reduction 4 log 10) V. PROCEDURAL MODIFICATIONS/PROTOCOL AMENDMENTS Two protocol amendments were written during the course of this study at SwRI which consisted of change of the completion date and change of personnel. Protocol amendments at ATS Labs were detailed in Appendix 2.

8 Southwest Research Institute Page 8 of 8 Microencapsulation and Nanomaterials Department Amended Final Report: GLP Virucidal Testing of ZeroMold Plus for HIV-1 Protocol No.: GLP-SP-239 VI. STUDY CONCLUSIONS Under the condition of this study and in the presence of 5% organic soil load, samples of ZeroMold Plus demonstrated complete inactivation of HIV-1 virus tested following a 10 minute exposure at room temperature as required by U.S. EPA, Health Canada, and Australian TGA. ZeroMold Plus is qualified as a one-step disinfectant for the HIV-1 virus. All original records (or exact copies of originals) of final reports will be kept at SwRI. VII. RECORD & SAMPLE RETENTION In accordance with SwRI TAP , Conduct of a GLP Study, copies of the protocol, appendices, amendments, and the analytical method shall be available to the analysts, technicians and chemists involved in the study at SwRI. The analysts at SwRI shall maintain laboratory notebooks or equivalent documents in which they will record all procedures, weighing, observations, etc., relevant to the experimental work. Chromatograms, computer printouts, etc., will be clearly labeled and notebooks will remain in the analyst's possession throughout the study. Records shall be archived as written in SwRI TAP , Project Setup and Record Archival for GLP. At the completion of the analytical portion of the study, a report shall be prepared as specified in SwRI TAP , Final Report for GLP Studies, and delivered to the sponsor for final approval. After completion of the final report for the study, all methodology, raw data sheets, and original chromatograms will be inspected by the QAU at SwRI. At the sponsor's discretion, all original records will be sent to sponsor for archiving in accordance with 40 CFR 160. The study for a research or marketing permit approved by EPA shall be maintained for the period during which the sponsor holds that research or marketing permit to which the study is pertinent unless all originals are provided to the client. For samples remaining at the conclusion of the study, SwRI will either have samples returned to the sponsor or disposed after five years from market permit submission to EPA. Materials that degrade will not be maintained. VIII. REFERENCES CAN/CGSB Assessment of Efficacy of Antimicrobial Agents for Use on Environmental Surface and Medical Devices Disinfectants for Use on Hard Surfaces Environmental Protection Agency. Product Performance Test Guidelines. OCSPP : Disinfectants for Use on Hard Surfaces - Efficacy Data Recommendations. IX. APPENDIX SwRI GLP protocol and ATS test report are provided in the following appendix. Appendix 1: SwRI GLP study protocol. Appendix 2: ATS GLP final study report and protocol (ATS project number A17321)

9 Southwest Research Institute Page 1 of 5 Department of Microencapsulation and Nanomaterials SwRI Project Title: GLP Virucidal Testing of ZeroMold Plus for HIV-1 GLP-SP-239 GLP-SP-239 STUDY PROTOCOL GLP Virucidal Testing of ZeroMold Plus for HIV-1 SOUTHWEST RESEARCH INSTITUTE STUDY NUMBER DATA REQUIREMENTS OCSPP ASTM E Test Method for Efficacy of Virucidal Agents Intended for Inanimate Environmental Surfaces TESTING FACILITY ATS Labs, Inc. (ATS) 1285 Corporate Center Drive, Suite 110 Eagan, MN Phone: Fax: Southwest Research Institute (SwRI) Department of microencapsulation and Nanomaterials 6220 Culebra Road San Antonio, TX USA Tel: Fax: SPONSOR BIOSENTA Inc Finch Ave, West Suite 503 Toronto, Ontario, M3J 3H7 CANADA PH:

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11 Southwest Research Institute Page 3 of 5 Department of Microencapsulation and Nanomaterials SwRI Project Title: GLP Virucidal Testing of ZeroMold Plus for HIV-1 GLP-SP OBJECTIVE BIOSENTA Inc. is interested in assessing its ZeroMold Plus Product as an intermediate and/or low-level disinfectant that kills pathogenic and potentially pathogenic microorganisms on hard non-porous inanimate surfaces or inanimate objects, when used according to labeling. This project aims to perform Virucidal Efficacy of a Disinfectant for Use on Inanimate Environmental Surfaces. Testing will be performed at ATS Labs at the facility addresses provided in the cover. This lab has been audited for the Approved Supplier List. The project will be performed in compliance with EPA's current FIFRA Good Laboratory Practices Standard (40 CFR 160). 2. TEST SUBSTANCES Two lots of ZeroMold Plus at Lower Certified Limit (LCL) will be tested. At least one lot will be aged (>60 days old). BIOSENTA provided the ZeroMold Plus to SwRI. SwRI previously performed titration and dilution the product to LCL according to GLP protocol (GLP-SP-210) and will ship the products to ATS Labs for testing. 3. TEST SYSTEM/ANALYTICAL METHOD ATS Labs will provide test protocols/methods for the below test by referencing ASTM E a) GLP virucidal test (Human Immunodeficiency Virus Type I) for HIV-1 claim 4. JUSTIFICATION OF TEST SYSTEM Annual Book of ASTM Standards, Section 11 Water and Environmental Technology Volume Pesticides; Environmental Assessment; Hazardous Substances and Oil Spill Response, E CAN/CGSB Assessment of Efficacy of Antimicrobial Agents for Use on Environmental Surface and Medical Devices Disinfectants for Use on Hard Surfaces EFFICACY DATA REQUIREMENTS Supplemental Efficacy DRAFT GUIDELINES FOR THE EVALUATION OF HOUSEHOLD/COMMERCIAL AND HOSPITAL GRADE DISINFECTANTS Australian Therapeutic Goods Administration (TGA), July 2005.

12 Southwest Research Institute Page 4 of 5 Department of Microencapsulation and Nanomaterials SwRI Project Title: GLP Virucidal Testing of ZeroMold Plus for HIV-1 GLP-SP STUDY PERSONNEL Xingguo Cheng, SwRI, study director Karen Ramm, ATS Labs, MN (ATS Labs will provide their personnel details) 6. MAJOR EQUIPMENT N/A 7. CALCULATIONS ATS Labs will provide the relevant calculations on the GLP protocol. 8. QUALITY ASSURANCE/GOOD LABORATORY PRACTICES SwRI maintains a Quality Assurance Unit/Division Quality Assurance (QAU/DQA)) in compliance with EPA's current FIFRA Good Laboratory Practices Standard (40 CFR 160). The QAU/DQA will conduct periodic inspections of this study to assure conformance to the study protocol, standard operating procedures and GLP. The inspection results will be reported to SwRI management and the SwRI study director through the Quality Reporting System. The final report will be reviewed by the QAU/DQA, and a signed Quality Assurance Statement will be included which specifies the date inspections/audits were made and reported to SwRI management and the SwRI study director. 9. RECORDS TO BE MAINTAINED In accordance with SwRI TAP , Conduct of a GLP Study, copies of the protocol, appendices, amendments, and the analytical method shall be available to the analysts, technicians and chemists involved in the study at SwRI. The analysts at SwRI shall maintain laboratory notebooks or equivalent documents in which they will record all procedures, weighing, observations, etc., relevant to the experimental work. Chromatograms, computer printouts, etc., will be clearly labeled and notebooks will remain in the analyst's possession throughout the study. Records shall be archived as written in SwRI TAP , Project Setup and Record Archival for GLP. Training records shall be maintained for appropriate procedures and Protocols.

13 Southwest Research Institute Page 5 of 5 Department of Microencapsulation and Nanomaterials SwRI Project Title: GLP Virucidal Testing of ZeroMold Plus for HIV-1 GLP-SP-239 At the completion of the analytical portion of the study, a report shall be prepared as specified in SwRI TAP , Final Report for GLP Studies, and delivered to the sponsor for final approval. Following completion of the final report for the study, all methodology, raw data sheets, and original chromatograms will be inspected by the QAU/DQA at SwRI. At the sponsor's discretion, all original records will be sent to the sponsor for archiving in accordance with 40 CFR Part SAMPLE AND RECORD RETENTION The study for a research or marketing permit approved by EPA shall be maintained for the period during which the sponsor holds that research or marketing permit to which the study is pertinent unless all originals are provided to the client. For samples remaining at the conclusion of the study SwRI will either return samples to the sponsor or dispose the sample after which the sponsor holds that research or marketing permit to which the study is pertinent unless all originals are provided to the client (EPA). Materials that degrade will not be maintained.

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