Relevant bibliographies by topics / Sterility assurance level (SAL)

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Academic literature on the topic 'Sterility assurance level (SAL)'

Author: Grafiati
Published: 3 June 2025
Last updated: 31 July 2025

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Journal articles on the topic "Sterility assurance level (SAL)"

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Srun, Sopheak W., Brian J. Nissen, Trabue D. Bryans, and Maxime Bonjean. "Medical Device SALs And Surgical Site Infections: A Mathematical Model." Biomedical Instrumentation & Technology 46, no. 3 (2012): 230–37. http://dx.doi.org/10.2345/0899-8205-46.3.230.

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It is commonly accepted that terminally sterilized healthcare products are rarely the source of a hospital-acquired infection (HAI). The vast majority of HAIs arise from human-borne contamination from the workforce, the clinical environment, less-than-aseptic handling techniques, and the patients themselves. Nonetheless, the requirement for a maximal sterility assurance level (SAL) of a terminally sterilized product has remained at 10−6, which is the probability of one in one million that a single viable microorganism will be on a product after sterilization. This paper presents a probabilisti
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Swenson, Donna, Jonathan A. Wilder, and Charles O. Hancock. "Steam Sterilization Validation for Implementation of Parametric Release at a Healthcare Facility." Biomedical Instrumentation & Technology 44, no. 2 (2010): 166–74. http://dx.doi.org/10.2345/0899-8205-44.2.166.

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Abstract Hospitals are under continual pressure to improve turnaround times for surgical procedures and to find ways to release sterilized product without the need to wait for biological indicator (BI) results. Current procedures used in healthcare do not allow for release of sterilized products based on parameters because hospitals do not validate their sterilization processes. Once a sterilization process is validated for a particular product family, those loads may be released based upon evaluation of the sterilization parameters achieved in the cycle, i.e., parametric release. Typically, h
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McEvoy, Brian, Stacy Bohl Wiehle, Ken Gordon, Gerry Kearns, Paulo Laranjeira, and Nicole McLees. "Advancing the Sustainable Use of Ethylene Oxide through Process Validation." Biomedical Instrumentation & Technology 55, s3 (2021): 35–44. http://dx.doi.org/10.2345/0899-8205-55.s3.35.

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Abstract Based on excellent material compatibility and ability for scale, ethylene oxide (EO) sterilization constitutes approximately 50% of single-use medical device sterilization globally. Epidemiological considerations have elevated focus toward optimization of EO processes, whereby only necessary amounts of sterilant are used in routine processing. EO sterilization of medical devices is validated in accordance with AAMI/ANSI/ISO 11135:2014 via a manner in which a sterility assurance level (SAL) of 10−6 is typically achieved, with multiple layers of conservativeness delivered, using “overki
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Al-Gheethi, Adel, Mohammed Al-Sahari, Marlinda Abdul Malek, et al. "Disinfection Methods and Survival of SARS-CoV-2 in the Environment and Contaminated Materials: A Bibliometric Analysis." Sustainability 12, no. 18 (2020): 7378. http://dx.doi.org/10.3390/su12187378.

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The presence of SARS-CoV-2 in sewage and water resources has been used as an indication for the possible occurrence of the virus among communities and for its potential of transmission among humans through the surrounding environment or water resources. In order to reduce the transmission of SARS-CoV-2, contaminated surfaces should be disinfected frequently by using an effective disinfectant. The present review discusses a bibliometric analysis of the global SARS-CoV-2 research and focuses mainly on reviewing the efficiency of the most traditional disinfection technologies. The disinfection me
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Rahman, Md Shajadur, Farzana Diba, Md Hasib Adnan, et al. "Genotyping and Determination of Radiation Sensitivity Pattern of Multidrug-Resistant Bacteria Isolated from Human Amniotic Membrane." Bioresearch Communications 11, no. 2 (2025): 1787–800. https://doi.org/10.3329/brc.v11i2.82637.

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Background: The transplantation of human amniotic membrane (HAM) is a significant accomplishment in the fields of cosmetic surgery, ocular surgery, epidermis, abdominal and vaginal reconstruction, and cosmetic surgery, as it has the potential to save thousands of lives annually. Nevertheless, the risk of infectious disease transmission using amniotic membrane allografts is a significant concern, as microorganisms can be introduced into the grafts during tissue procurement. Objectives: This study aimed at the genotypic characterization of the multidrug-resistant (MDR) membrane-associated bacter
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Daniell, Elaine, Trabue Bryans, Kimbrell Darnell, Joyce Hansen, Victoria M. Hitchins, and Manuel Saavedra. "Product Sterility Testing . . . To Test or Not to Test? That Is the Question." Biomedical Instrumentation & Technology 50, s3 (2016): 35–43. http://dx.doi.org/10.2345/0899-8205-50.s3.35.

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Abstract The applications for sterility testing in the validation and routine control of sterilization of medical devices have changed dramatically over the years. As the definition of sterility assurance has evolved, so has the state of the science associated with product sterility testing. Historically, product sterility testing has been applied to such things as sterilization validation, sterilization lot release, packaging qualification, aseptic processing qualification, and determination of shelf life for the packaged medical device. In most of these cases, however, the results obtained f
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Cooper, Douglas. "Sterility Assurance for Cleanroom Wipers." Journal of the IEST 39, no. 3 (1996): 31–36. http://dx.doi.org/10.17764/jiet.2.39.3.y8m7k34n48754252.

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Procedures specified by the Association for the Advancement of Medical Instrumentation (AAMI) are used by Texwipe and some other wiper manufacturers to certify the sterility of sterile wipers. The tests assure that there is less than one chance in a million of having a viable particle on one of these sterile wipers when the package is first opened. In six of seven sets of wipers tested, the count distribution data supported the hypothesis that the bioburden (colony-forming units, cfu, per wiper) had a Poisson count distribution, which would come from having a uniform probability of finding a v
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Ordinaria, Ruella, John E. Moores, Grace Bischof, and Andrew C. Schuerger. "Bioburden Reductions on the Europa Clipper Spacecraft During its MEGA-trajectory Cruise to Jupiter." Research Notes of the AAS 9, no. 7 (2025): 175. https://doi.org/10.3847/2515-5172/aded09.

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Abstract The Cruise-Phase Microbial Survival (CPMS) model was used to estimate the bioburden reduction on the Europa Clipper (EC) spacecraft during its transit to Jupiter based on the final flown Mars–Earth gravity assist (MEGA) trajectory, a trajectory not considered in previous work. The CPMS model evaluates the bioburden reduction due to UV radiation, temperature, and vacuum. Under the MEGA trajectory, bioburdens on external and shallow interior surfaces accumulate the highest reductions due to the synergistic effects of temperature and vacuum, contributing to hundreds of thousands of Steri
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Khushbu*, Dr. Peeyush Jain Dr. Pankaj Chasta. "Microbial Contamination and Sterility Testing in Injectable Pharmaceuticals – Ensuring Sterility Assurance and Contamination Control." International Journal of Pharmaceutical Sciences 3, no. 5 (2025): 792–809. https://doi.org/10.5281/zenodo.15343825.

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Background: The presence of microbial contamination in injectable pharmaceuticals poses significant risks to patient safety and product efficacy. Ensuring sterility in drug manufacturing is critical for maintaining product integrity and compliance with regulatory standards. Objective: This study aimed to establish a comprehensive microbial surveillance framework for sterile drug manufacturing facilities, focusing on contamination control and sterility assurance. Approach: A systematic approach was employed, which included routine monitoring of microbial presence, identification of contaminants
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Dunkelberg, Hartmut, and Ulrich Schmelz. "Determination of the Efficacy of Sterile Barrier Systems Against Microbial Challenges During Transport and Storage." Infection Control & Hospital Epidemiology 30, no. 2 (2009): 179–83. http://dx.doi.org/10.1086/593208.

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Objective.The sterility assurance level of 10−6 is an established standard that defines the quality of sterile products. The aim of the present study was to develop a method that correlated the results from microbial-barrier testing of flexible sterile barrier systems with the estimated microbial challenge that the package encounters during storage and transport.Methods.The effectiveness of microbial-barrier packaging was determined by the use of an exposure chamber test with 20 periodic atmospheric pressure changes of 50 and 70 hPa. Flexible peel pouches were used as sterile barrier systems.
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Books on the topic "Sterility assurance level (SAL)"

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ANSI/AAMI ST67:2019; Sterilization of health care products— Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled “sterile”. AAMI, 2019. http://dx.doi.org/10.2345/9781570207273.

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AAMI TIR76:2021; Sterilization of health care products—Radiation—Substantiation of a selected sterilization dose at a specified sterility assurance level: Method VDmaxSD-S. AAMI, 2021. http://dx.doi.org/10.2345/9781570208188.

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Book chapters on the topic "Sterility assurance level (SAL)"

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Conley, Catharine A. "Sterility Assurance Level." In Encyclopedia of Astrobiology. Springer Berlin Heidelberg, 2011. http://dx.doi.org/10.1007/978-3-642-11274-4_1519.

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Conley, Catharine A. "Sterility Assurance Level." In Encyclopedia of Astrobiology. Springer Berlin Heidelberg, 2015. http://dx.doi.org/10.1007/978-3-662-44185-5_1519.

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Spry, J. Andy. "Sterility Assurance Level." In Encyclopedia of Astrobiology. Springer Berlin Heidelberg, 2023. http://dx.doi.org/10.1007/978-3-662-65093-6_5592.

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Spry, J. Andy. "Sterility Assurance Level." In Encyclopedia of Astrobiology. Springer Berlin Heidelberg, 2022. http://dx.doi.org/10.1007/978-3-642-27833-4_5592-1.

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Conley, Catharine A. "Sterility Assurance Level." In Encyclopedia of Astrobiology. Springer Berlin Heidelberg, 2014. http://dx.doi.org/10.1007/978-3-642-27833-4_1519-2.

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"Sterilization of health care products— Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled “sterile”." In ANSI/AAMI ST67:2019; Sterilization of health care products— Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled “sterile”. AAMI, 2019. http://dx.doi.org/10.2345/9781570207273.ch1.

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Shintani, Hideharu. "Concomitant Achievement of a Sterility Assurance Level of 10-6 with Material and Functional Compatibility by Gas Plasma Sterilization." In Gas Plasma Sterilization in Microbiology: Theory, Applications, Pitfalls and New Perspectives. Caister Academic Press, 2016. http://dx.doi.org/10.21775/9781910190258.03.

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"Sterilization of health care products—Radiation—Substantiation of a selected sterilization dose at a specified sterility assurance level: Method VD max SD-S." In AAMI TIR76:2021; Sterilization of health care products—Radiation—Substantiation of a selected sterilization dose at a specified sterility assurance level: Method VDmaxSD-S. AAMI, 2021. http://dx.doi.org/10.2345/9781570208188.ch1.

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You might also be interested in the extended bibliographies on the topic 'Sterility assurance level (SAL)' for particular source types:
Journal articles
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