Page 1 of 5 Department of Microencapsulation and Nanomaterials SwRI Project GLP-SP-241 STUDY PROTOCOL
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1 Southwest Research Institute Page 1 of 5 Department of Microencapsulation and Nanomaterials SwRI Project Title: GLP Testing of ZeroMold Plus for Additional 7 Microorganisms GLP-SP-241 GLP-SP-241 STUDY PROTOCOL GLP Testing of ZeroMold Plus for Additional 7 Microorganisms SOUTHWEST RESEARCH INSTITUTE STUDY NUMBER DATA REQUIREMENTS OCSPP ASTM E Assess Virucidal Activity of Chemicals Intended for Disinfection of Inanimate, Nonporous 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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4 Southwest Research Institute Page 3 of 5 Department of Microencapsulation and Nanomaterials SwRI Project Title: GLP Testing of ZeroMold Plus for Additional 7 Microorganisms 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 or Efficacy of a Disinfectant for Use on Inanimate Environmental Surface. 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 has shipped the products to ATS Labs for testing. 3. TEST SYSTEM/ANALYTICAL METHOD For Chlamydia trachomatis, ATS Labs will provide GLP test protocol/method for Efficacy of a Disinfectant for Use on Inanimate Environmental Surface. For organisms listed from b to g below, ATS Labs will provide GLP test protocols/methods for Virucidal Efficacy of a Disinfectant for Use on Inanimate Environmental Surfaces. The below test organisms will be used: a. Chlamydia trachomatis* b. Rotavirus c. Vaccinia (pox) virus d. Adenovirus type 4 e. Adenovirus type 14 f. Human Hepatitis B virus surrogate g. Human Hepatitis C virus surrogate *Note: According to CDC website Although they (chlamydia trachomatis) are classified as bacteria, they share properties with viruses and bacteria. Like viruses, chlamydiae grow only intracellularly ( As a result, all the above organisms are tested in a virology lab. The testing procedures used are also similar. 4. JUSTIFICATION OF TEST SYSTEM Annual Book of ASTM Standards, Section 11 Water and Environmental Technology Volume
5 Southwest Research Institute Page 4 of 5 Department of Microencapsulation and Nanomaterials SwRI Project Title: GLP Testing of ZeroMold Plus for Additional 7 Microorganisms GLP-SP 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 STUDY PERSONNEL Xingguo Cheng, SwRI, study director Shanon Conway, 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.
6 Southwest Research Institute Page 5 of 5 Department of Microencapsulation and Nanomaterials SwRI Project Title: GLP Testing of ZeroMold Plus for Additional 7 Microorganisms GLP-SP 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. 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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