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

Author: Grafiati

Published: 3 June 2025

Last updated: 19 July 2025

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1

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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9

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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10

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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Schuerger, Andrew C. "Synergistic Interactions among Vacuum, Solar Heating, and UV Irradiation Enhance the Lethality of Interplanetary Space." Microorganisms 12, no. 10 (2024): 1976. http://dx.doi.org/10.3390/microorganisms12101976.

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A Planetary Atmospheric Chamber (PAC) was used to create simulations of interplanetary conditions to test the spore survival of three Bacillus spp. exposed to interacting conditions of vacuum (VAC), simulated solar heating (HEAT), and simulated solar ultraviolet irradiation (UV). Synergism was observed among the experimental factors for all three Bacillus spp. tested that suggested the increased lethality of HEAT and UV when concomitantly exposed to VAC. The most aggressive biocidal effects were observed for assays with VAC + HEAT + UV conditions run simultaneously over short time-steps. The r

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Logar, John R., and Emily Craven. "Radiation Process Control: Product Dose vs. Process Dose." Biomedical Instrumentation & Technology 54, s1 (2020): 53–63. http://dx.doi.org/10.2345/0899-8205-54.s3.53.

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Abstract The requirements for the irradiation of healthcare products have been well established and implemented across the globe for several decades. The ISO 11137 series of standards gives the user the road map for designing a radiation process that will routinely deliver the required sterility assurance level so that product consistently meets specifications. The latest addition to the ISO 11137 series of standards should provide much-needed guidance around establishing a highly reproducible process based on a statistical analysis of the validated state of control. Most industries refer to t

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Hasan Arif, Sayeedul, and Siddiqui AF. "Quality Assessment of Packed Red Cell Prepared by Different Methods." Clinical Pathology & Research Journal 8, no. 1 (2024): 1–10. https://doi.org/10.23880/cprj-16000198.

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Background: Blood transfusion plays a pivotal role in modern health care systems. Since the advent of components preparation, Packed Red Cell (PRBC) prepared by any of the standard methods are maximum used components, followed by platelet concentrate (RDP) or single donor platelet (SDP). As per the Drug and Cosmetic Acts (1942), amended time to time, blood and its products are considered as a human product and therefore strict quality assurance should be followed as per standard operative procedure (SOP). The background of this study was to evaluate the quality assurance of PRBC prepared by th

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14

Looy, Kris, Olivier Honnay, and Peter Breyne. "Adaptive strategy of a spreading gynodioecious plant species (Origanum vulgare, Labiatae) in a riparian corridor." Plant Ecology and Evolution 144, no. (2) (2011): 138–47. https://doi.org/10.5091/plecevo.2011.549.

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<b>Backgrounds and aims</b> – <i>Origanum vulgare</i> L. is a successfully recovering gynodioecious species in the ecological restoration project along the Common Meuse (Belgium). Strong contrasts exist between spreading – mostly newly established – populations on the one hand, and remnant, declining populations on the other hand. The flowering strategy of the species was assumed to be related to these differences in population status. Two alternative hypotheses for small, isolated populations were postulated: either they contain more sterile individuals due to their presence in marginal condi

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15

Botelho, M. L., E. Almeida-Vara, R. Tenreiro, and M. E. Andrade. "Searching for a strategy to gamma-sterilize Portuguese cork stoppers — preliminary studies on bioburden, radioresistance and sterility assurance level." International Journal of Radiation Applications and Instrumentation. Part C. Radiation Physics and Chemistry 31, no. 4-6 (1988): 775–81. http://dx.doi.org/10.1016/1359-0197(88)90258-5.

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Ward, Richard A., Jörg Vienken, Douglas M. Silverstein, Stephen Ash, and Bernard Canaud. "Regulatory Considerations for Hemodiafiltration in the United States." Clinical Journal of the American Society of Nephrology 13, no. 9 (2018): 1444–49. http://dx.doi.org/10.2215/cjn.12641117.

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Online hemodiafiltration provides greater removal of higher molecular weight uremic retention solutes than conventional high-flux hemodialysis. However, online hemodiafiltration is used sparsely in the United States in part because of a paucity of delivery systems cleared for clinical use by the US Food and Drug Administration. Although a pathway for regulatory approval exists in the United States, concerns remain, particularly regarding online production of the large volumes of sterile, nonpyrogenic substitution fluid infused directly into the bloodstream to maintain fluid balance. Clearly de

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Ledebo, Ingrid. "On-line Preparation of Solutions for Dialysis: Practical Aspects Versus Safety and Regulations." Journal of the American Society of Nephrology 13, suppl 1 (2002): S78—S83. http://dx.doi.org/10.1681/asn.v13suppl_1s78.

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ABSTRACT. On-line preparation, i.e., continuous mixing and immediate use, was introduced for dialysis fluid in 1964, and it contributed significantly to the expansion of dialysis therapy through simplified handling, improved microbiology, and enhanced efficiency. On-line prepared replacement solution for hemofiltration was shown to be clinically safe as early as 1978, but the implementation was delayed for 20 yr because of regulatory conservatism. On-line preparation of sterile and pyrogen-free solutions for infusion is based on the use of water and concentrates that contribute a minimum of mi

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18

Ruhl, Stefan, Pereshia Berlenbach, Sabine Langenfelder, et al. "Integrity of Proteins in Human Saliva after Sterilization by Gamma Irradiation." Applied and Environmental Microbiology 77, no. 3 (2010): 749–55. http://dx.doi.org/10.1128/aem.01374-10.

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ABSTRACTMicrobial contamination of whole human saliva is unwanted for certainin vitroapplications, e.g., when utilizing it as a growth substratum for biofilm experiments. The aim of this investigation was to test gamma irradiation for its suitability to sterilize saliva and to investigate the treatment's influence on the composition and integrity of salivary proteins in comparison to filter sterilization. For inhibition of bacterial growth by gamma irradiation, a sterility assurance level of 10−6was determined to be reached at a dose of 3.5 kGy. At this dose, the integrity of proteins, as meas

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19

Mata-Portuguez, Victor Hugo, Leonor Sánchez Pérez, and Enrique Acosta-Gío. "Sterilization of Heat-Resistant Instruments With Infrared Radiation." Infection Control & Hospital Epidemiology 23, no. 7 (2002): 393–96. http://dx.doi.org/10.1086/502072.

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Objective:To evaluate the lethality profile of an infrared radiation (IR) prototype sterilizer.Method:Simulated use and D value tests were conducted with Bacillus subtilis spores American Type Culture Collection–9372. A spore suspension (1.06 ± 0.03 × 106) in 5% bovine serum albumin was air dried on stainless steel instruments. IR cycles were completed and the instruments were immersed in tryptic soy broth for 120 hours at 37°C. Direct enumeration of survivors was performed to evaluate IR death. Instrument loads contained carriers laden with spores (1.06 ± 0.3 × 106). The spores were seeded on

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Penna, Thereza Christina Vessoni, and Carlos Augusto M. Ferraz. "Cleaning of Blood-Contaminated Reprocessed Angiographic Catheters and Spinal Needles." Infection Control & Hospital Epidemiology 21, no. 8 (2000): 499–504. http://dx.doi.org/10.1086/501793.

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Objectives:To evaluate the efficacy of a multistep cleaning method using a cleaner and a chemical disinfectant on blood-contaminated angiographic catheters and spinal needles intended to be sterilized by hydrogen peroxide gas plasma.Method:A mixture of radiopaque iodine contrast, bovine blood (plus ethylenediaminetetraacetic acid), and a suspension of Bacillus subtilis spores was used to simulate catheterization and needle use. The mixture was a 1:1 proportion of contrast and blood, inoculated so that there was a final concentration of B subtilis spores of 1.0×106 colony-forming units (CFU)/mL

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Zahid, Hasan M., Mohammad Zahirul Islam Mollah, and Ruhul A. Khan. "Gamma Irradiation to Sterilize Active Ingredients, Consumer Foodstuffs and Beverages in Bangladesh." Scientific Review, no. 81 (March 4, 2022): 33–37. http://dx.doi.org/10.32861/sr.81.33.37.

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Nowadays, the utilization of gamma irradiation (e.g., Cobalt-60 source) to sterilize different materials have been increasing enormously. As terminal sterilization, gamma irradiation is being used popularly to sterilize different materials throughout Bangladesh. Compare to other conventional methods of sterilization (e.g., alpha, beta, other chemicals), this method is highly applicable for its well acceptance in the world. It has high penetration power with the short wave lengths, isothermal characteristics for its negligible rise in the temperature, no contact with any toxic chemicals without

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Maillet, Christina, Florence M. Klein, Florian Le Bras, et al. "Cytocompatibility of titanium and poly(etheretherketone) surfaces after O2 non-thermal plasma sterilization." PLOS ONE 18, no. 8 (2023): e0290820. http://dx.doi.org/10.1371/journal.pone.0290820.

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The sterilization of medical devices is paramount to achieve an acceptable level of sterility assurance and to prevent hospital-acquired infections. However, some medical devices cannot be sterilized by usual processes such as autoclave (AC) and gamma-ray irradiation (GI). A new non-thermal plasma (NTP) process using sealed bag that preserves the sterile state of the devices could be used as an alternative sterilization method. The aim of the study was to assess the cytocompatibility of titanium and poly(etheretherketone) (PEEK) surfaces after O2-NTP sterilization compared to GI and AC. MG-63

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Tomiyoshi, Katsumi, Yuta Namiki, David J. Yang, and Tomio Inoue. "Production, Validation, and Exposure Dose Measurement of [13N]Ammonia Under Academic Good Manufacturing Practice Environments." Pharmaceutics 17, no. 5 (2025): 667. https://doi.org/10.3390/pharmaceutics17050667.

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Objective: Current good manufacturing practice (cGMP) guidance for positron emission tomography (PET) drugs has been established in Europe and the United States. In Japan, the Pharmaceuticals and Medical Devices Agency (PMDA) approved the use of radiosynthesizers as medical devices for the in-house manufacturing of PET drugs in hospitals and clinics, regardless of the cGMP environment. Without adequate facilities, equipment, and personnel required by cGMP regulations, the quality assurance (QA) and clinical effectiveness of PET drugs largely depend on the radiosynthesizers themselves. To bridg

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Hideharu, Shintani. "Sterilization Mechanism of Nitrogen Gas Plasma Exposure." March 9, 2015. https://doi.org/10.19070/2470-4490-150001e.

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As already published by Shintani et al, gas plasma sterilization is the alternative sterilization procedures to the existing sterilization procedures due to applicable to the several sensitive healthcare products and attainable both sterility assurance level (SAL) of 10-6 and material/functional compatibility, which authorities and GMP (good manufacturing practice) are required. In addition there was progress in the field of plasma-based sterilization, there are still some questions. The aim of this editorial is to mention briefly some of un-resolved sterilization mechanisms as well as to draw

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Shintani, Hideharu. "Simultaneous Achievement of Sterility Assurance Level (SAL) of 10-6 and Material and Functional Compatibility in Gas Plasma Sterilization." Pharmaceutical Regulatory Affairs: Open Access 04, no. 01 (2015). http://dx.doi.org/10.4172/2167-7689.1000131.

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Schuerger, Andrew C., and John E. Moores. "UV Reflectance of Spacecraft Materials and Analog Soils: Implications for Bioburden Reductions on the Undersides of Mars Rovers." Journal of Geophysical Research: Planets 128, no. 12 (2023). http://dx.doi.org/10.1029/2023je007975.

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AbstractThe Mars Sample Return mission architecture will utilize three spacecraft to collect, cache, recover, launch, and return to Earth a diversity of regolith and rock samples. However, no comprehensive Mars Microbial Survival (MMS) model currently exists. As an initial effort in building an MMS model, we examined the UV reflectance of 15 spacecraft materials and seven Mars analog soils within the context of the Perseverance mission. Data were used to predict the times required to achieve one lethal dose (syn., Sterility Assurance Level [SAL]; def. as a bioburden reduction of −12 logs). Res

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Türker, Selcan, A. Yekta Özer, Burak Kutlu, et al. "Gamma Irradiation Studies I. Dental Grafts." Journal of Medical Devices 5, no. 3 (2011). http://dx.doi.org/10.1115/1.4004647.

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The development of nanoceramics-polymer composites and bioactive materials such as calcium phosphates and bioglasses and ceramics especially hydroxyapatite (HAp) and β-tricalcium phosphate (TCP) for bone regeneration has been carried out for bone regeneration. Due to their resorption in the body and direct contact with tissues, it is necessary to sterilize the dental graft before administration to the patient. Three different dental graft materials including TCP, bioglass, and equine bone tissue (G1, G2, and G3, respectively) were studied in this study. The effects of γ irradiation were evalua

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Truong, Van Dat, Quang Duong Do, and Van Hoa Huynh. "STUDYING THE PARAMETERS THAT AFFECT THE EFFICIENCY OF THE STERILIZATION PROCESS VALIDATION." Journal of Medicine and Pharmacy, June 2012, 42–46. http://dx.doi.org/10.34071/jmp.2012.3.7.

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Background: Sterility is required for sterile drug products so they must be sterilized by the sterilization process has been validated. Demonstrating the efficiency of the sterilization process can not only base on the results of sterility tests but also must calculate many other parameters. Calculating SAL will increase the assurance, the efficiency of the sterilization process and save execution time. Materials and methods: Studying the parameters that affect the efficiency of the sterilization process validation. Basing on survey results process validation at 13 pharmaceutical factories hav

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Selcan Turker, N., A. Yekta Özer, Burak Kutlu, et al. "The Effect of Different Sterilization Methods on Polypropylene Syringes." Journal of Medical Devices 12, no. 2 (2018). http://dx.doi.org/10.1115/1.4039434.

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This presents the influence of gamma irradiation on Pharmacopeia specifications, mechanical and flow parameters of polypropylene (PP) syringes. There has been significant progress in the terminal sterilization of single-use, disposable medical devices with gamma radiation sterilization due to the growing awareness of toxic residues during the ethylene oxide (EtO) sterilization. PP is a widely used polymer for the production of syringes because of its excellent mechanical and thermal properties and has expanded continuously over the last decade. Although 25 kGy was generally recommended for the

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Susanto, Agus, Ira Komara, Maria Theresia Beatrix, et al. "Determination of the Sterilization Dose of Gamma-Ray Irradiation for Polyvinyl Alcohol-Collagen-Chitosan Composite Membrane as a Material for Periodontal Regenerative Surgery." European Journal of Dentistry, June 27, 2023. http://dx.doi.org/10.1055/s-0043-1761186.

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Abstract Objective Membrane sterility is very necessary considering its function as an implant material. Therefore, this research aims to determine the dose of gamma-ray irradiation for the sterilization of polyvinyl alcohol (PVA)–collagen–chitosan composite membranes used as regenerative surgery materials. Materials and Methods A total of 100 pieces of the composite membranes were prepared in a size of 2.0 × 1.5 cm by mixing 7.5% PVA, 3% collagen, and 2% chitosan using the film casting method in three batches. Furthermore, the bioburden test was performed to determine the initial microbial co

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Kranenburg, Holger, Birte Scharf, Patrick Wolf, and Robert Lindner. "End-to-end qualification of ready-to-use (RTU) product containers in packaging suitable for No-Touch Transfer (NTT) into Grade A filling zones." EJPPS EUROPEAN JOURNAL OF PARENTERAL AND PHARMACEUTICAL SCIENCES, December 20, 2021. http://dx.doi.org/10.37521/ejpps.26401.

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No-Touch Transfer (NTT) of pre-sterilised ready-to-use (RTU) containers is an alternative methodology that follows Good Manufacturing Practice (GMP) and Quality Risk Management (QRM) principles. NTT de-bagging ejects contents from secondary bag packaging without direct contact with contents or exposure to an environment that is a lower grade than the zone being entered. The pre-sterilised containers and sterile barriers offer assured sterility at manufacture and are qualified to remain sterile through the supply chain and the stepwise NTT de-bagging process. This eliminates the requirement for

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Gitsov, Ioan P. I., Yunzhi Liu, David M. Saylor, et al. "Diffusion of Hydrogen Peroxide Through Medical Grade Poly(Ether)urethane: Analyzing Mechanisms of Sorption and Transport to Support Sterilization With Vapor Phase Hydrogen Peroxide." Journal of Biomedical Materials Research Part B: Applied Biomaterials 113, no. 5 (2025). https://doi.org/10.1002/jbm.b.35567.

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ABSTRACTThe United States Food and Drug Administration (FDA) recently announced an update to their 510(k) medical device sterility guidance to include vapor phase hydrogen peroxide (VH2O2) as an established ‘Category A’ sterilization process. This places VH2O2 in the same category as ethylene oxide (EO or EtO), which has demonstrated user and patient safety as well as microbiocidal effectiveness through scientific literature and FDA‐recognized consensus standards. For some implantable medical devices, the sterilant chemistry must diffuse through the polymers of construction to access sealed pa

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Seet, Wan Tai, Mohd Asyraf Mat Afandi, Mohamad Fikeri Ishak, et al. "Quality management overview for the production of a tissue-engineered human skin substitute in Malaysia." Stem Cell Research & Therapy 14, no. 1 (2023). http://dx.doi.org/10.1186/s13287-023-03536-9.

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AbstractTreatments for skin injuries have recently advanced tremendously. Such treatments include allogeneic and xenogeneic transplants and skin substitutes such as tissue-engineered skin, cultured cells, and stem cells. The aim of this paper is to discuss the general overview of the quality assurance and quality control implemented in the manufacturing of cell and tissue product, with emphasis on our experience in the manufacturing of MyDerm®, an autologous bilayered human skin substitute. Manufacturing MyDerm® requires multiple high-risk open manipulation steps, such as tissue processing, ce

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Garvey, M., T. A. Kremer, and N. J. Rowan. "Efficacy of cleaning, disinfection and sterilization modalities for addressing infectious drug-resistant fungi: A review." Journal of Applied Microbiology, January 7, 2025. https://doi.org/10.1093/jambio/lxaf005.

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Abstract This is a timely and important review that focuses on the appropriateness of established cleaning, disinfection and sterilization methods to safely and effectively address infectious fungal drug-resistant pathogens that can potentially contaminate reusable medical devices used in healthcare environment in order to mitigate the risk of patient infection. The release of the World Health Organisation (WHO) fungal priority pathogen list (FPPL) in 2022 highlighted the public health crisis of antimicrobial resistance (AMR) in clinically relevant fungal species. Contamination of medical devi

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