Applied Biosafety最新文献_第10页

Exploring Goal Conflicts and How They Are Managed in a Biomedical Laboratory Using Rasmussen's Model of Boundaries. 探索目标冲突及其如何在生物医学实验室使用拉斯穆森的边界模型进行管理。

IF 1.5

Applied Biosafety Pub Date : 2020-04-30 DOI: 10.1177/1535676020919624

Vijith Vijayan, A. Smoker

{"title":"Exploring Goal Conflicts and How They Are Managed in a Biomedical Laboratory Using Rasmussen's Model of Boundaries.","authors":"Vijith Vijayan, A. Smoker","doi":"10.1177/1535676020919624","DOIUrl":"https://doi.org/10.1177/1535676020919624","url":null,"abstract":"Introduction: Occupational health and safety management systems are widely used as a systematic approach to managing occupational health and safety. However, sometimes they are restrictive and underspecified to deal with dynamic workplace demands. Rasmussen used a model of boundaries to conceptualize this dynamic model of safety, where the space of possibilities lay within 3 boundaries and workers used various means to stay within the boundaries to remain both productive and safe at work. Methods: This study applied the Rasmussen model of boundaries to understand the factors that formed the boundaries, the gradients, and countergradients in a biomedical laboratory. Results: The most central goal was to be the first to publish, and this formed the boundary to scientific output failure; the boundary to unacceptable workload and boundary to functionally acceptable performance were the other 2 boundaries in line with the Rasmussen model. The workers had developed methods (mental risk assessment, teamwork, and experience and familiarity) of working, which ensured they remained productive and safe. This can be described as resilient performance, where resilience is not something that a system has but something it does to adjust their performance when faced with expected or unexpected changes. Discussion and Conclusion: A customized portfolio of rule-based non negotiable instructions and a risk assessment-based approach would be best suited for a biomedical laboratory. The workers have learned resilient performance on their own and unknowingly are already practicing this. It is now time to formally incorporate such practices into the safety systems of biomedical laboratories.","PeriodicalId":7962,"journal":{"name":"Applied Biosafety","volume":"276 1","pages":"S43-S55"},"PeriodicalIF":1.5,"publicationDate":"2020-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79522302","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Technical and Anatomical Considerations for Reproducible Inactivation of Large Animal Carcasses by Steam Sterilization. 大型动物尸体蒸汽灭菌可重复灭活的技术和解剖学考虑。

IF 1.5

Applied Biosafety Pub Date : 2020-04-29 DOI: 10.1177/1535676020919637

J. Schinköthe, Benjamin Bartram-Sitzius, J. Teifke, U. Pfitzner, S. Reiche

{"title":"Technical and Anatomical Considerations for Reproducible Inactivation of Large Animal Carcasses by Steam Sterilization.","authors":"J. Schinköthe, Benjamin Bartram-Sitzius, J. Teifke, U. Pfitzner, S. Reiche","doi":"10.1177/1535676020919637","DOIUrl":"https://doi.org/10.1177/1535676020919637","url":null,"abstract":"Introduction: The complete inactivation of infectious tissues of large animal carcasses is one of the most challenging tasks in high-containment facilities. Steam sterilization is a method frequently in use to achieve biological inactivation of liquid and solid waste. Objective: This study aims to highlight parameters most effective in creating reproducible cycles for steam sterilization of pig and calf carcasses. Methods: Two pigs or 1 calf were sterilized by running a liquid cycle (n = 3) at 121°C for at least 120 minutes in a pass-through autoclave. To assess the physical and biological parameters, temperature data loggers and biological indicators (BIs) with spores of Geobacillus stearothermophilus (ATCC 7953) were placed at defined positions within animal carcasses. After completion of each cycle, data loggers were analyzed and BIs were incubated for 7 days at 60°C. Results: Initial testing with an undissected pig carcass resulted in suboptimal temperatures at the tissue level with growth on 1 BI. After modifications of the used stainless-steel boxes and by placing the reference probe of the autoclave in the animal carcass, reproducible cycles could be created. A complete inactivation of BIs and a temperature profile of >121°C for at least 20 minutes could be achieved in almost all probed tissues. Conclusion: Only minor modifications in carcass preparation and the used sterilization equipment resulted in effective and reproducible cycles to inactivate large animal carcasses by using a steam autoclave.","PeriodicalId":7962,"journal":{"name":"Applied Biosafety","volume":"93 1","pages":"14-22"},"PeriodicalIF":1.5,"publicationDate":"2020-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83859460","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

A Cross-Sectional Survey of Biosafety Professionals Regarding Genetically Modified Insects. 关于转基因昆虫的生物安全专业人员横断面调查。

IF 1.5

Applied Biosafety Pub Date : 2020-03-01 DOI: 10.1177/1535676019888047

David A O'Brochta, Willy K Tonui, Brinda Dass, Stephanie James

{"title":"A Cross-Sectional Survey of Biosafety Professionals Regarding Genetically Modified Insects.","authors":"David A O'Brochta, Willy K Tonui, Brinda Dass, Stephanie James","doi":"10.1177/1535676019888047","DOIUrl":"https://doi.org/10.1177/1535676019888047","url":null,"abstract":"Background: Genetic technologies such as gene editing and gene drive create challenges for existing frameworks used to assess risk and make regulatory determinations by governments and institutions. Insect genetic technologies including transgenics, gene editing, and gene drive may be particularly challenging because of the large and increasing number of insect species being genetically modified and the degree of familiarity with these organisms and technologies by biosafety officials charged with making containment decisions. Methods: An anonymous online survey of biosafety professionals was distributed to the membership of ABSA International, a global society of biosafety professionals, to investigate their perspectives on their preparedness to meet these new challenges. Results: Existing guidance used to make containment decisions for nongenetically modified insects was widely seen as adequate, and most respondents thought the available guidance for making containment decisions for genetically modified insects with and without gene drives was inadequate. Most respondents reported having less confidence in their decisions concerning containment of genetically modified insects compared to decisions involving genetically modified microbes, (noninsect) animals, and plants. Conclusions: These results reveal a need for additional support for biosafety professionals to improve the quality of and confidence in containment decisions regarding genetically modified insects with and without gene drive. These needs might be addressed by increasing training, updating existing guidance, creating new guidance, and creating a third-party accreditation entity to support institutions. Sixty percent of the respondents said they either would or might use a voluntary third-party accreditation service to support insect containment decisions.","PeriodicalId":7962,"journal":{"name":"Applied Biosafety","volume":"25 1","pages":"19-27"},"PeriodicalIF":1.5,"publicationDate":"2020-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/1535676019888047","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10247180","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 4

Decontamination Validation of a Class II Type A2 Biosafety Cabinet during Laboratory Fumigation. ⅱ类A2型生物安全柜在实验室熏蒸过程中的去污验证。

IF 1.5

Applied Biosafety Pub Date : 2020-03-01 DOI: 10.1177/1535676019890975

Greg Frey, Cathy Robertson, Jay Krishnan

{"title":"Decontamination Validation of a Class II Type A2 Biosafety Cabinet during Laboratory Fumigation.","authors":"Greg Frey, Cathy Robertson, Jay Krishnan","doi":"10.1177/1535676019890975","DOIUrl":"https://doi.org/10.1177/1535676019890975","url":null,"abstract":"Objective: The objective of this study was to evaluate whether a Class II type A2 biosafety cabinet in a laboratory could be decontaminated while the laboratory was being fumigated using vaporous hydrogen peroxide or peracetic acid dry fogging.Methods: To validate decontamination of all parts of the biosafety cabinet, biological indicators were placed at various locations within the biosafety cabinet, including between the pleats of supply and exhaust HEPA filters. To assess whether the operational status of the biosafety cabinet influenced the outcome of its decontamination, fumigation validations were undertaken with the cabinet running and not running. The amount of fumigant and the duration of fumigation remained constant whether the biosafety cabinet was running or not.Discussion: Biosafety cabinet decontamination was successful only when the cabinet was running to facilitate the fumigant's circulation within the plenums and across the HEPA filters. This study shows both vaporous hydrogen peroxide and peracetic acid dry fogging can be used successfully to decontaminate Class II type A2 biosafety cabinets during laboratory fumigation, provided the biosafety cabinets are operational and running during the fumigation.","PeriodicalId":7962,"journal":{"name":"Applied Biosafety","volume":"25 1","pages":"48-52"},"PeriodicalIF":1.5,"publicationDate":"2020-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/1535676019890975","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10254345","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 6

Performance Testing of a Venturi-Based Backpack Spray Decontamination System. 文丘里式背包喷雾除污系统的性能测试。

IF 1.5

Applied Biosafety Pub Date : 2020-03-01 DOI: 10.1177/1535676019898299

Alan Beswick, Claire Bailey, Brian Crook, David Crouch, Jayne Farrant, Gillian Frost, Stephen Stagg

{"title":"Performance Testing of a Venturi-Based Backpack Spray Decontamination System.","authors":"Alan Beswick, Claire Bailey, Brian Crook, David Crouch, Jayne Farrant, Gillian Frost, Stephen Stagg","doi":"10.1177/1535676019898299","DOIUrl":"https://doi.org/10.1177/1535676019898299","url":null,"abstract":"Introduction: The performance of 2 disinfectant chemicals, peracetic acid (PAA) and hypochlorous acid (HOCl), was evaluated using a Venturi-nozzle-based light decontamination system (LDS) for delivery. The atomization equipment combined low-pressure air and disinfectant via a handheld lance, producing a fine, dense aerosol. A range of microorganisms, including Bacillus cereus and Bacillus anthracis (Vollum) spores, were used as test challenges to evaluate chemicals and equipment.Methods: The tests undertaken included assessments over fixed and variable exposure times, use of multiple surface materials, and a live agent challenge.Results: Over a fixed-time exposure of 60 minutes, aerosolized PAA gave 7- to 8-log reductions of all test challenges, but HOCl was less effective. Material tests showed extensive kill on most surfaces using PAA (≥6-log kill), but HOCl showed more variation (4- to 6-log). Testing using B. anthracis showed measurable PAA induced spore kill inside 5 minutes and >6-log kill at 5 minutes or over. HOCl was less effective.Discussion: The results demonstrate the importance of testing decontamination systems against a range of relevant microbiological challenges. Disinfectant efficacy may vary depending on product choice, types of challenge microorganisms, and their position in a treated area. The most effective disinfectants demonstrate biocidal efficacy despite these factors.Conclusion: The data confirmed PAA as an effective disinfectant capable of rapidly killing a range of microorganisms, including spores. HOCl was less effective. The LDS system successfully delivered PAA and HOCl over a wide area and could be suitable for a range of frontline biosecurity applications.","PeriodicalId":7962,"journal":{"name":"Applied Biosafety","volume":"25 1","pages":"28-40"},"PeriodicalIF":1.5,"publicationDate":"2020-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/1535676019898299","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10255749","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Development of Improved Devices for Handling and Restraining Experimental Laboratory Mice. 实验小鼠处理和抑制装置的改进。

IF 1.5

Applied Biosafety Pub Date : 2020-03-01 DOI: 10.1177/1535676019892068

Moshe Aftalion, David Gur, Noach Shalom, Yinon Levy, Avital Tidhar, Yaron Vagima, Ayelet Zauberman, Tseela David, Amir Rosner, Shay Weiss, Emanuelle Mamroud

{"title":"Development of Improved Devices for Handling and Restraining Experimental Laboratory Mice.","authors":"Moshe Aftalion, David Gur, Noach Shalom, Yinon Levy, Avital Tidhar, Yaron Vagima, Ayelet Zauberman, Tseela David, Amir Rosner, Shay Weiss, Emanuelle Mamroud","doi":"10.1177/1535676019892068","DOIUrl":"https://doi.org/10.1177/1535676019892068","url":null,"abstract":"Introduction: Most animal handling procedures are associated with injuries among veterinary staff and laboratory animal researchers. However, much of the currently available animal handling equipment is inadequate, limiting access to the treated animal or making workflow cumbersome. Moreover, restraining animals to perform procedures, such as blood collection or injection, elicits stress in both the animal and the worker. Herein, we present 4 home-built restraint and blood collection devices in extensive use in our institute.Methods: Animal laboratory workers and experienced veterinarians regularly using the devices (n = 14) were asked to complete a survey ranking the contribution of the devices to worker safety and procedural efficiency.Results: The overwhelming majority of responders (≥75%) associated all 4 devices with substantial improvements in worker safety and procedural efficiency. There were no reports of impaired workflow or safety when using the devices.Discussion: Infection and exposure control may be implemented on various levels, including use of safer procedures, such as injection and blood collection devices. The presented intuitive handling and restraint devices allow the animal worker/researcher to perform various procedures safely and efficiently while eliciting less animal and worker stress. The devices can be easily adjusted to accommodate animal size and disease status.Conclusion: The current devices will serve as prototypes for design of devices for larger laboratory animals.","PeriodicalId":7962,"journal":{"name":"Applied Biosafety","volume":"25 1","pages":"53-58"},"PeriodicalIF":1.5,"publicationDate":"2020-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/1535676019892068","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10621994","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Impact of Educational Intervention on Knowledge, Attitudes, and Practices of Laboratory Technicians regarding Universal Work Precautions at a Tertiary Health Care Center in Central India. 教育干预对印度中部三级卫生保健中心实验室技术人员关于普遍工作预防措施的知识、态度和做法的影响

IF 1.5

Applied Biosafety Pub Date : 2020-02-05 DOI: 10.1177/1535676020902607

A. Mehta, Manish Kr. Diwakar

{"title":"Impact of Educational Intervention on Knowledge, Attitudes, and Practices of Laboratory Technicians regarding Universal Work Precautions at a Tertiary Health Care Center in Central India.","authors":"A. Mehta, Manish Kr. Diwakar","doi":"10.1177/1535676020902607","DOIUrl":"https://doi.org/10.1177/1535676020902607","url":null,"abstract":"Introduction: Laboratory technicians are routinely exposed to occupational health hazards that can be a serious threat to their health. To safeguard themselves against laboratory-acquired infections, they must be aware of universal work precautions. A targeted educational intervention to increase awareness about universal precautions was designed to result in behavioral changes in attitudes and practices to help reduce the incidence of laboratory-acquired infections. This study was planned to assess the preexisting levels of knowledge, attitudes, and practices of laboratory technicians regarding universal work precautions at a tertiary care hospital in central India and to evaluate the effectiveness of educational interventions on the same. Method: The 40 lab technicians participating in the study were subjected to educational interventions in the form of training on universal precautions. Pretest and posttest evaluations using questionnaires were conducted to evaluate the learning gain. Pretest and posttest responses to each question were compared using the Pearson chi-square test. The subjects' mean pretest and posttest scores were compared using paired t tests, and the significance level was set at .05. Results: There was remarkably significant improvement in knowledge, attitudes, and practices of laboratory technicians regarding universal work precautions after the educational intervention/training sessions. Conclusion: On the basis of the findings, it was suggested that such training sessions should be conducted regularly for laboratory technicians to help in better retention of knowledge and to instill a positive attitude toward universal precautions.","PeriodicalId":7962,"journal":{"name":"Applied Biosafety","volume":"26 Suppl 1 1","pages":"S27-S33"},"PeriodicalIF":1.5,"publicationDate":"2020-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/1535676020902607","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"65496277","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 1

Case Study: Room Fumigation Using Aerosolized Hydrogen Peroxide-A Versatile and Economic Fumigation Method. 案例研究：使用气溶胶过氧化氢进行室内熏蒸--一种多功能且经济的熏蒸方法。

IF 0.5

Applied Biosafety Pub Date : 2019-12-01 DOI: 10.1177/1535676019887049

Daniel Kümin, Monika Gsell Albert, Kathrin Summermatter

{"title":"Case Study: Room Fumigation Using Aerosolized Hydrogen Peroxide-A Versatile and Economic Fumigation Method.","authors":"Daniel Kümin, Monika Gsell Albert, Kathrin Summermatter","doi":"10.1177/1535676019887049","DOIUrl":"10.1177/1535676019887049","url":null,"abstract":"Introduction: Formaldehyde is still the method of choice for fumigation of rooms and HEPA filters at high- and maximum-containment facilities because of its proven track record and low cost. However, formaldehyde has been shown to be carcinogenic and should ideally be replaced by other, less hazardous methods. This change has in part been hampered by the relatively high cost of alternative methods.Methods: Here, we provide examples of room fumigations using aerosolized hydrogen peroxide showing not only that it can be used economically but also that it is a versatile method and may be used under circumstances not normally suited for fumigation.Results and discussion: Four examples of fumigation setups are presented that illustrate the versatility, ease of use, and adaptability of aerosolized hydrogen peroxide as a fumigant. In addition, we demonstrate that aerosolized hydrogen peroxide passes through HEPA filters in biological safety cabinets and individually ventilated cage racks.Conclusions: Considering that the fumigation method presented here is simple and highly effective, we expect it to serve as a relatively cost-effective alternative to formaldehyde fumigation for disinfecting potentially contaminated rooms and surfaces.","PeriodicalId":7962,"journal":{"name":"Applied Biosafety","volume":"24 4","pages":"200-206"},"PeriodicalIF":0.5,"publicationDate":"2019-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9134476/pdf/1535676019887049.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33441884","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

The Evolving Landscape of Institutional Biosafety Committees and Biosafety Programs: Results from a National Survey on Organizational Structure, Resources, and Practices. 机构生物安全委员会和生物安全计划的演变景观:来自组织结构、资源和实践的全国调查结果。

IF 1.5

Applied Biosafety Pub Date : 2019-12-01 DOI: 10.1177/1535676019886175

Christine M Johnson, Karen M Dobos

{"title":"The Evolving Landscape of Institutional Biosafety Committees and Biosafety Programs: Results from a National Survey on Organizational Structure, Resources, and Practices.","authors":"Christine M Johnson, Karen M Dobos","doi":"10.1177/1535676019886175","DOIUrl":"https://doi.org/10.1177/1535676019886175","url":null,"abstract":"Introduction: There are vast differences in the size, scope, and needs of institutions that conduct research involving biohazardous materials, thus resulting in vast differences among Institutional Biosafety Committees (IBCs) and biosafety programs.Methods: A benchmarking survey of IBC and biosafety programs was conducted in an effort to identify common practices in the field and compare this information with that of the other institutional bioethics committees, namely, Institutional Animal Care and Use Committees (IACUCs) and Institutional Review Boards (IRBs).Objectives: The primary objectives of the survey were to assess the organizational structure of IBC and biosafety programs, determine the scope of IBC review, and compare the size of IBC and biosafety programs with that of IACUCs and IRBs.Results: The survey results showed that IBCs most commonly reside under the same administrative unit as the IACUC and IRB, while the majority of institutions' biosafety officers report to a different unit. The majority of respondents indicated their IBC reviews research utilizing biological hazards beyond what is required by the National Institutes of Health Guidelines. The survey data suggest that IBCs have fewer support staff than the other bioethics committees; 57% of institutions report one or more full-time employee (FTE) dedicated to support the IBC, compared to 86%, 85%, and 83% of institutions that reported one or more FTE to support the IACUC, the IRB, and the biosafety program, respectively.Conclusion: Data from the survey identified common practices among IBCs and provides institutions a tool to compare their program with others.","PeriodicalId":7962,"journal":{"name":"Applied Biosafety","volume":"24 4","pages":"213-219"},"PeriodicalIF":1.5,"publicationDate":"2019-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/1535676019886175","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33441886","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Validation of the Bio-Response Solutions Human-28 Low-Temperature Alkaline Hydrolysis System. 生物反应溶液Human-28低温碱性水解体系的验证。

IF 1.5

Applied Biosafety Pub Date : 2019-12-01 DOI: 10.1177/1535676019871389

Gerald A Denys

{"title":"Validation of the Bio-Response Solutions Human-28 Low-Temperature Alkaline Hydrolysis System.","authors":"Gerald A Denys","doi":"10.1177/1535676019871389","DOIUrl":"https://doi.org/10.1177/1535676019871389","url":null,"abstract":"Introduction: High temperature alkaline hydrolysis (AH) is recognized as an alternative method for sterilization and disposition of animal carcasses and human remains. The aim of this study is to validate the low temperature (LT) AH process specific to its use in the Bio-Response Solutions, Inc. Human-28 LT System.Methods: A 313-lb pig was processed using the manufacturers recommended cycle parameters. Stainless steel sample vials containing spore suspensions of Geobacillus stearothermophilus were implanted into the pig's deep tissue to validate the efficacy of the process conditions. Spore suspensions of Bacillus thuringiensis were suspended in the vessel headspace to validate sterilization. The spore challenge was greater than the recommended 106 log used to determine sterilization. MALDI-TOF mass spectrometry analysis was used to validate the destruction of prion-sized particles in processed effluent.Results: Complete inactivation of spores and digestion of animal tissue were achieved after processing in the Bio-Response Solutions Human-28 LT Alkaline Hydrolysis System. Complete inactivation of spores was achieved when exposed to heat in the animal carcass and headspace. No peptide fragments larger than 2500 Da were observed in the treatment effluent.Discussion: The Bio-Response Solutions, Inc. Human-28 LT Alkaline Hydrolysis System was as effective as high-temperature alkaline hydrolysis for use on animal and human tissue.Conclusion: LT AH for tissue and bodies exceeded the sterility assurance level III of the US State and Territorial Association on Alternative Treatment Technologies and sterility requirements for animal biosafety level-3 and -4 facilities. LT AH process validated destruction of prion-sized particles.","PeriodicalId":7962,"journal":{"name":"Applied Biosafety","volume":"24 4","pages":"182-188"},"PeriodicalIF":1.5,"publicationDate":"2019-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/1535676019871389","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33441887","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0