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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 Q4 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2020-04-30 DOI: 10.1177/1535676020919624
Vijith Vijayan, A. Smoker
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.
职业健康与安全管理体系作为一种管理职业健康与安全的系统方法被广泛使用。然而,有时它们在处理动态的工作场所需求方面是限制性的和不明确的。Rasmussen使用了一个边界模型来概念化安全的动态模型,在这个模型中,可能性的空间位于3个边界内,工人们使用各种方法来保持在边界内以保持工作的生产力和安全。方法:应用Rasmussen边界模型了解生物医学实验室边界、梯度和反梯度的形成因素。结果:最核心的目标是第一个发表,这形成了科学产出失败的边界;可接受工作量的边界和功能可接受性能的边界是符合Rasmussen模型的另外两个边界。工人们已经开发了工作方法(精神风险评估、团队合作、经验和熟悉程度),这确保了他们保持生产力和安全。这可以被描述为弹性性能,其中弹性不是系统所具有的东西,而是在面临预期或意外变化时调整其性能的东西。讨论与结论:基于规则的、不可协商的指示和基于风险评估的方法的定制组合将最适合生物医学实验室。工人们已经学会了自己的弹性表现,并在不知不觉中已经在实践这一点。现在是将这些做法正式纳入生物医学实验室安全系统的时候了。
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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 Q4 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2020-04-29 DOI: 10.1177/1535676020919637
J. Schinköthe, Benjamin Bartram-Sitzius, J. Teifke, U. Pfitzner, S. Reiche
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.
引言:在高密闭设施中,大型动物尸体的传染性组织的完全灭活是最具挑战性的任务之一。蒸汽灭菌是一种常用的方法,用于实现液体和固体废物的生物灭活。目的:本研究旨在强调最有效的参数,以建立可重复循环的猪和小牛尸体蒸汽灭菌。方法:2头猪或1头小牛在121°C的高压灭菌器中进行液体循环(n = 3)至少120分钟的灭菌。为了评估物理和生物学参数,将温度数据记录仪和带有嗜脂嗜热地杆菌孢子(ATCC 7953)的生物指示剂(BIs)放置在动物尸体的指定位置。每个周期完成后,对数据记录仪进行分析,并将BIs在60℃下孵育7天。结果:在未解剖的猪胴体上进行的初步测试表明,在1 BI上生长的组织水平上温度不理想。在对使用过的不锈钢箱进行改造后,通过将高压灭菌器的参考探针放置在动物胴体中,可以创建可重复的循环。在几乎所有被探测的组织中,可以实现BIs的完全失活和>121℃至少20分钟的温度分布。结论:仅对屠体制备和使用的灭菌设备进行少量修改,就可以使用蒸汽高压灭菌器实现有效且可重复的大型动物屠体灭活循环。
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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 Q4 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2020-03-01 DOI: 10.1177/1535676019888047
David A O'Brochta, Willy K Tonui, Brinda Dass, Stephanie James
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.
背景:基因编辑和基因驱动等遗传技术给政府和机构用于评估风险和做出监管决定的现有框架带来了挑战。包括转基因、基因编辑和基因驱动在内的昆虫遗传技术可能特别具有挑战性,因为正在进行基因改造的昆虫种类越来越多,而且负责制定遏制决策的生物安全官员对这些生物和技术的熟悉程度也越来越高。方法:向ABSA国际(一个全球性的生物安全专业人士协会)的成员分发了一份匿名的生物安全专业人士在线调查,调查他们对应对这些新挑战的准备情况的看法。结果:人们普遍认为,用于对非转基因昆虫作出收容决定的现有指导是充分的,大多数答复者认为,用于对有或没有基因驱动的转基因昆虫作出收容决定的现有指导是不充分的。大多数答复者报告说,与涉及转基因微生物、(非昆虫)动物和植物的决定相比,他们对有关遏制转基因昆虫的决定缺乏信心。结论:这些结果表明,需要为生物安全专业人员提供额外支持,以提高有关有或没有基因驱动的转基因昆虫的控制决策的质量和信心。这些需求可以通过增加培训、更新现有指南、创建新指南和创建第三方认证实体来支持机构来解决。60%的受访者表示,他们要么会或可能会使用自愿的第三方认证服务来支持昆虫控制决策。
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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 Q4 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2020-03-01 DOI: 10.1177/1535676019890975
Greg Frey, Cathy Robertson, Jay Krishnan

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.

目的:本研究的目的是评估在实验室使用蒸汽过氧化氢或过氧乙酸干雾熏蒸时,是否可以对实验室II类A2型生物安全柜进行消毒。方法:为了验证生物安全柜各部位的去污效果,在生物安全柜内的各个位置,包括供气和排气HEPA过滤器褶之间放置生物指示剂。为了评估生物安全柜的运行状态是否影响其去污结果,在柜子运行和不运行的情况下进行了熏蒸验证。无论生物安全柜是否运行,熏蒸剂的用量和熏蒸时间都保持不变。讨论:只有当生物安全柜运行以促进熏蒸剂在全体会议和HEPA过滤器内的循环时,生物安全柜去污才能成功。本研究表明,在实验室熏蒸过程中,如果生物安全柜处于运行状态,则蒸汽过氧化氢和过氧乙酸干雾法都可以成功地用于II类A2型生物安全柜的去污。
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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 Q4 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2020-03-01 DOI: 10.1177/1535676019898299
Alan Beswick, Claire Bailey, Brian Crook, David Crouch, Jayne Farrant, Gillian Frost, Stephen Stagg

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.

简介:采用文丘里喷嘴光去污系统(LDS)对过氧乙酸(PAA)和次氯酸(HOCl)两种消毒液的性能进行了评价。雾化设备通过手持喷枪将低压空气和消毒剂结合在一起,产生细而致密的气溶胶。一系列微生物,包括蜡样芽孢杆菌和炭疽芽孢杆菌孢子,被用作评估化学品和设备的测试挑战。方法:所进行的试验包括对固定和可变暴露时间、多种表面材料的使用和活剂挑战的评估。结果:在60分钟的固定时间暴露中,雾化PAA使所有测试挑战减少了7到8 log,但HOCl的效果较差。材料测试表明,PAA在大多数表面上具有广泛的杀伤作用(≥6-log),但HOCl表现出更多的变化(4- 6-log)。用炭疽芽孢杆菌进行的试验表明,PAA诱导的孢子在5分钟内杀死量可测量,在5分钟或更长时间内杀死量大于6 log。HOCl效果较差。讨论:结果表明测试净化系统对一系列相关微生物挑战的重要性。消毒剂的功效可能因产品选择、挑战微生物的类型及其在处理区域的位置而异。尽管存在这些因素,但最有效的消毒剂仍显示出杀灭生物的功效。结论:该数据证实PAA是一种有效的消毒剂,能够快速杀死一系列微生物,包括孢子。HOCl效果较差。LDS系统成功地在大范围内提供了PAA和HOCl,可以适用于一系列一线生物安全应用。
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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 Q4 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH 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

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.

大多数动物处理程序都与兽医工作人员和实验动物研究人员的伤害有关。然而,目前大部分可用的动物处理设备都不充分,限制了对治疗动物的访问或使工作流程繁琐。此外,限制动物执行诸如采血或注射等程序,会引起动物和工人双方的压力。在此,我们介绍了在我们研究所广泛使用的4种自制的约束和采血装置。方法:要求经常使用器械的动物实验室工作人员和经验丰富的兽医(n = 14)完成一项调查,对器械对工作人员安全和程序效率的贡献进行排名。结果:绝大多数应答者(≥75%)将所有4种器械与工人安全和程序效率的实质性改善联系起来。在使用这些设备时,没有关于工作流程或安全性受损的报告。讨论:感染和暴露控制可在不同层面实施,包括使用更安全的程序,如注射和采血装置。所提出的直观处理和约束装置允许动物工作者/研究人员安全有效地执行各种程序,同时减少动物和工人的压力。该装置可以很容易地调整,以适应动物的大小和疾病状态。结论:目前的设备将作为设计大型实验动物设备的原型。
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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 Q4 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2020-02-05 DOI: 10.1177/1535676020902607
A. Mehta, Manish Kr. Diwakar
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.
导言:实验室技术人员经常接触可能对其健康构成严重威胁的职业健康危害。为了保护自己免受实验室获得性感染,他们必须了解普遍的工作预防措施。一项有针对性的教育干预旨在提高对普遍预防措施的认识,从而导致态度和做法的行为改变,以帮助减少实验室获得性感染的发生率。本研究计划评估印度中部一家三级护理医院实验室技术人员对普遍工作预防措施的现有知识、态度和做法水平,并评估教育干预措施的有效性。方法:对40名参与研究的实验室技术人员进行普遍预防措施培训的教育干预。采用问卷法进行前测和后测评价。使用Pearson卡方检验比较每个问题的前测和后测反应。受试者前测和后测均分比较采用配对t检验,显著性水平设为0.05。结果:经过教育干预/培训,实验室技术人员对普适性工作注意事项的知识、态度和实践均有显著提高。结论:根据调查结果,建议应定期对实验室技术人员进行此类培训,以帮助他们更好地保留知识,并灌输对普遍预防措施的积极态度。
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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 Q4 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2019-12-01 DOI: 10.1177/1535676019887049
Daniel Kümin, Monika Gsell Albert, Kathrin Summermatter

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.

简介:甲醛因其良好的记录和低廉的成本,仍然是高封闭性和最高封闭性设施中熏蒸房间和高效空气过滤器的首选方法。然而,甲醛已被证明具有致癌性,最好用其他危害较小的方法来取代。方法:在此,我们提供了使用过氧化氢气溶胶进行室内熏蒸的例子,不仅表明这种方法可以经济地使用,而且表明它是一种多用途方法,可以在通常不适合熏蒸的情况下使用:结果与讨论:本文介绍了四个熏蒸装置实例,说明了气雾过氧化氢作为熏蒸剂的多功能性、易用性和适应性。此外,我们还展示了气雾过氧化氢可通过生物安全柜和独立通风笼架中的高效空气过滤器:考虑到本文介绍的熏蒸方法简单而高效,我们希望它能成为甲醛熏蒸消毒潜在污染房间和表面的一种相对经济有效的替代方法。
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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 Q4 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2019-12-01 DOI: 10.1177/1535676019886175
Christine M Johnson, Karen M Dobos

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.

导言:从事涉及生物有害物质研究的机构在规模、范围和需求方面存在巨大差异,因此导致机构生物安全委员会(IBCs)和生物安全计划之间存在巨大差异。方法:对IBC和生物安全计划进行基准调查,以确定该领域的共同做法,并将这些信息与其他机构生物伦理委员会(即机构动物护理和使用委员会(IACUCs)和机构审查委员会(irb))的信息进行比较。目的:调查的主要目的是评估IBC和生物安全计划的组织结构,确定IBC审查的范围,并将IBC和生物安全计划的规模与IACUCs和irb的规模进行比较。结果:调查结果显示,机构生物安全中心与IACUC和IRB隶属于同一行政单位,而大多数机构的生物安全官员隶属于不同的行政单位。大多数答复者表示,他们的IBC审查了超出国家卫生研究院指南要求的利用生物危害的研究。调查数据表明,生物伦理委员会的支持人员少于其他生物伦理委员会;57%的机构报告有一名或多名全职员工(FTE)致力于支持IBC,相比之下,分别有86%、85%和83%的机构报告有一名或多名全职员工支持IACUC、IRB和生物安全项目。结论:来自调查的数据确定了IBCs的共同做法,并为机构提供了将其计划与其他计划进行比较的工具。
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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 Q4 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2019-12-01 DOI: 10.1177/1535676019871389
Gerald A Denys

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.

简介:高温碱性水解(AH)是公认的灭菌和处理动物尸体和人类遗骸的替代方法。本研究的目的是验证低温(LT) AH工艺在Bio-Response Solutions, Inc.中的具体应用。人类-28 LT系统。方法:采用生产厂家推荐的循环参数对313磅生猪进行加工。将含有嗜脂嗜热地杆菌孢子悬浮液的不锈钢样品瓶植入猪的深层组织,以验证该工艺条件的有效性。苏云金芽孢杆菌孢子悬浮液悬浮在容器顶空以验证灭菌。孢子挑战大于用于确定灭菌的推荐的106 log。采用MALDI-TOF质谱分析验证了处理废水中朊病毒大小颗粒的破坏作用。结果:在Bio-Response Solutions Human-28 LT碱性水解系统中处理后,实现了孢子的完全失活和动物组织的消化。孢子完全失活时,暴露在动物尸体和顶空的热量。处理出水中未见大于2500 Da的肽片段。讨论:Bio-Response Solutions, Inc.human - 28lt碱性水解系统与高温碱性水解系统一样适用于动物和人体组织。结论:组织和机体的LT AH超过了美国州和地区替代处理技术协会的无菌保证III级和动物生物安全3级和4级设施的无菌要求。LT AH工艺验证了朊病毒大小颗粒的破坏。
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引用次数: 0
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Applied Biosafety
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