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Articles de revues sur le sujet « Sterility testing »

Auteur : Grafiati

Publié le 7 juin 2025

Mis à jour le 2 août 2025

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1

Smith, A. "Sterility testing of devices." British Dental Journal 212, no. 6 (2012): 259–60. http://dx.doi.org/10.1038/sj.bdj.2012.229.

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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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Novik, E. S., and O. V. Gunar. "Sterility testing of insulin preparations." Pharmaceutical Chemistry Journal 41, no. 3 (2007): 176–77. http://dx.doi.org/10.1007/s11094-007-0039-9.

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Khushbu*1, Dr. Peeyush Jain2 Dr. Pankaj Chasta3. "Microbial Contamination and Sterility Testing in Injectable Pharmaceuticals: Advances in Sterility Assurance and Contamination Control." International Journal of Pharmaceutical Sciences 3, no. 4 (2025): 1119–33. https://doi.org/10.5281/zenodo.15184997.

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The pharmaceutical industry is experiencing significant advancements in sterility assurance and contamination control for injectable pharmaceuticals. This review highlights the critical importance of maintaining sterility, as regulatory bodies such as the USP, EP, JP, FDA, and EMA impose stringent requirements to ensure product safety and efficacy. Traditional sterility testing methods face limitations, prompting the adoption of rapid microbiological techniques that enhance detection capabilities and reduce testing times. As the industry shifts towards continuous manufacturing, the integration

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BROWN, STEPHEN, and MICHAEL H. BAKER. "The sterility testing of dispensed radiopharmaceuticals." Nuclear Medicine Communications 7, no. 5 (1986): 327–36. http://dx.doi.org/10.1097/00006231-198605000-00002.

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S, Shanmugam, Valarmathi S, and Satheesh Kumars. "STERILITY TESTING PROCEDURE OF OPHTHALMIC OCUSERT ACICLOVIR USED FOR TREATING HERPES SIMPLEX VIRUS." Asian Journal of Pharmaceutical and Clinical Research 10, no. 10 (2017): 344. http://dx.doi.org/10.22159/ajpcr.2017.v10i10.19216.

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Objective: The present work focuses on sterility studies of prepared aciclovir ocusert which is so essential for ophthalmic preparations. According to Indian Pharmacopoeia, the sterility test was performed. Ocuserts are sterile preparations which are placed into cul-de-sac or conjunctival sac. Ophthalmic inserts offer many advantages over conventional dosage forms such as increased ocular residence time, possibility of releasing drugs at a slow and constant rate and accurate dosing. Ocuserts are formulated for treating external ocular diseases such as conjuctivitis, corneal ulcer, and keratoco

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Sukhanova, S. M., A. S. Tikhonova, and Z. E. Berdnikova. "Analysis of approaches to sterility testing of COVID-19 prevention vaccines." Biological Products. Prevention, Diagnosis, Treatment 23, no. 1 (2023): 65–75. http://dx.doi.org/10.30895/2221-996x-2023-23-1-65-75.

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Preventive vaccination against SARS-CoV-2 infection is currently receiving close attention in the Russian Federation. Improving public confidence in immunisation with new vaccines largely depends on a guarantee of the absence of side effects caused by contamination. A high risk of contamination is inherent to biological products, including coronavirus prevention vaccines, due to their properties and the nature of raw materials used. This risk adds to the need for using effective contaminant detection approaches.The aim of the study was to evaluate the possibility to improve sterility testing o

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Mishra, Abhishek K., and Vijay S. Wadhai. "Sterility Testing of Operation Theatres in Hospitals." International Journal of Current Microbiology and Applied Sciences 5, no. 5 (2016): 440–47. http://dx.doi.org/10.20546/ijcmas.2016.505.046.

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Diep, Benjamin, Julie Moulin, Viktoria Bastic-Schmid, et al. "Validation protocol for commercial sterility testing methods." Food Control 103 (September 2019): 1–8. http://dx.doi.org/10.1016/j.foodcont.2019.03.029.

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Bugno, Adriana, Deborah Pita Sanches Saes, Adriana Aparecida Buzzo Almodovar, et al. "Performance Survey and Comparison Between Rapid Sterility Testing Method and Pharmacopoeia Sterility Test." Journal of Pharmaceutical Innovation 13, no. 1 (2017): 27–35. http://dx.doi.org/10.1007/s12247-017-9303-z.

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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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Gulley, Savannah L., Sarah M. Baltzley, Alan D. Junkins, et al. "Sterility and Stability Testing of Preservative-free Albuterol." Journal of Pediatric Pharmacology and Therapeutics 24, no. 1 (2019): 53–57. http://dx.doi.org/10.5863/1551-6776-24.1.53.

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BACKGROUND Continuous albuterol administration (CAA) is commonly used in hospitalized patients for treatment of asthma exacerbations. Due to higher dose requirements, CAA requires large volumes of albuterol obtained from multidose vials containing benzalkonium chloride (BAC). BAC is a common pharmaceutical preservative and potent bronchoconstrictor, which may antagonize the bronchodilation effects of albuterol. Some institutions are using preservative-free (PF) albuterol for their CAA. However, no published data currently exist to support the extended sterility or stability of this formulation

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Berdnikova, Z. E., and A. S. Tikhonova. "Recommendations for the development of sterility testing procedures for biological medicinal products based on pharmacopoeial methods." Biological Products. Prevention, Diagnosis, Treatment 24, no. 2 (2024): 229–36. http://dx.doi.org/10.30895/2221-996x-2024-24-2-229-236.

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INTRODUCTION. The distinctive nature and composition of biological medicinal products present certain challenges for the detection of microbial contamination, which affects the reliability of sterility control results. The main challenges associated with testing biologicals include changes in the appearance and physical properties of culture media or samples, an increased risk of contamination or false-positive results in direct inoculation tests, filtration issues, etc. When drafting product specification files and analytical method validation reports in dossiers for biologicals, manufacturer

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STOPFORTH, J. D., B. KOTTAPALLI, and M. SAMADPOUR. "Sterility Testing of a Dispensing Valve for Aseptic Function in Food Service Applications." Journal of Food Protection 71, no. 3 (2008): 653–56. http://dx.doi.org/10.4315/0362-028x-71.3.653.

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Manual dispensing equipment for aseptically packaged beverages or foods requires refrigeration of the product package following breakage of the hermetic seal. The food service industry would benefit greatly by implementing dispensing equipment that maintains the sterility of products after continued use without the need for refrigeration. The purpose of this study was to evaluate the ability of a valve, designed to operate aseptically and dispense products with or without refrigeration, to maintain the sterility of products following breakage of the hermetic seal and continued use simulating t

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Bernuzzi, Maria Luisa. "Decontamination and Validation of Isolators for Sterility Testing." Biomedical Instrumentation & Technology 50, s3 (2016): 27–33. http://dx.doi.org/10.2345/0899-8205-50.s3.27.

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Abstract Decontamination with hydrogen peroxide is a technology widely used to reduce microbial contamination. A typical application of this technology is in the decontamination of sterility test isolators. This article describes how to decontaminate sterility test isolators and validate the process in order to demonstrate that the microbiological target has been achieved and that the risk of false negatives due to residuals of hydrogen peroxide is excluded. Hydrogen peroxide can adversely affect some materials, resulting in inhibition of microbial growth. A package integrity verification, foc

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Hernandez, Camellia L., Kirk H. Waibel, Susan E. Kosisky, Michael R. Nelson, and Taylor A. Banks. "15 years of allergen immunotherapy vial sterility testing." Annals of Allergy, Asthma & Immunology 118, no. 3 (2017): 374–75. http://dx.doi.org/10.1016/j.anai.2016.12.004.

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Gandhi, S. A., T. L. Romick, J. S. Kandel, and B. E. Beveridge. "Sterility testing of shelf-stable pudding by PCR." Food Microbiology 16, no. 4 (1999): 351–56. http://dx.doi.org/10.1006/fmic.1998.0253.

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Sadowski, Michael, Clark Houghtling, Sopheak Srun, et al. "The Ethylene Oxide Product Test of Sterility: Limitations and Interpretation of Results." Biomedical Instrumentation & Technology 55, s3 (2021): 45–56. http://dx.doi.org/10.2345/0899-8205-55.s3.45.

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Abstract The ethylene oxide (EO) product test of sterility (ToS) can be conducted to comply with ANSI/AAMI/ISO 11135:2014 for the generation of data to demonstrate the appropriateness of the biological indicator (BI) that is used to develop and qualify the EO sterilization process. Clause D.8.6 of 11135 provides an option to perform a sublethal EO process, followed by conducting a product ToS, performing sterility testing of BIs from the process challenge device, and comparing the test results. Certain limitations for the EO product ToS should be considered when conducting studies that feature

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Suss, Paula Hansen, Victoria Stadler Tasca Ribeiro, Juliette Cieslinski, Letícia Kraft, and Felipe Francisco Tuon. "Experimental procedures for decontamination and microbiological testing in cardiovascular tissue banks." Experimental Biology and Medicine 243, no. 17-18 (2018): 1286–301. http://dx.doi.org/10.1177/1535370218820515.

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Several methods for sampling, culturing, and decontaminating donor grafts are available for cardiovascular tissue banks. Most of these protocols are not standardized, leaving tissue banks to adapt their microbiological procedures to their tissue processing routines. Effective microbiological testing and decontamination procedures are essential to ensure tissue quality and safety for human application. This review presents the different procedures currently available for microbiological testing in cardiovascular tissue banks. Impact statement Sterility testing is a critical issue in the recover

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Levchuk, John W., Robert J. Nolly, and Naphtali Lander. "Method for Testing the Sterility of Total Nutrient Admixtures." American Journal of Health-System Pharmacy 45, no. 6 (1988): 1311–21. http://dx.doi.org/10.1093/ajhp/45.6.1311.

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Dubey, Maya. "Leveraging rapid sterility testing to advance cell therapy production." Cell and Gene Therapy Insights 10, no. 04 (2024): 609. http://dx.doi.org/10.18609/cgti.2024.073.

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Bronson, Michael H., Douglass J. Stennett, and Paulette K. Egging. "Sterility Testing of Home and Inpatient Parenteral Nutrition Solutions." Journal of Parenteral and Enteral Nutrition 12, no. 1 (1988): 25–28. http://dx.doi.org/10.1177/014860718801200125.

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Bussey, D. M., and K. Tsuji. "Bioluminescence for USP sterility testing of pharmaceutical suspension products." Applied and Environmental Microbiology 51, no. 2 (1986): 349–55. http://dx.doi.org/10.1128/aem.51.2.349-355.1986.

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López-Vinardell, L., N. Garin, L. Gras-Martín, et al. "MON-PO560: Sterility Testing of Total Parenteral Nutrition Solutions." Clinical Nutrition 38 (September 2019): S266—S267. http://dx.doi.org/10.1016/s0261-5614(19)32393-3.

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Roshchina, M. V., O. V. Gunar, and N. G. Sakhno. "Limit of Detection of Microorganisms in Drug Sterility Testing." Pharmaceutical Chemistry Journal 51, no. 6 (2017): 508–10. http://dx.doi.org/10.1007/s11094-017-1644-x.

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Singleton, Eve V., Shannon C. David, Justin B. Davies, et al. "Sterility of gamma-irradiated pathogens: a new mathematical formula to calculate sterilizing doses." Journal of Radiation Research 61, no. 6 (2020): 886–94. http://dx.doi.org/10.1093/jrr/rraa076.

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Abstract In recent years there has been increasing advocacy for highly immunogenic gamma-irradiated vaccines, several of which are currently in clinical or pre-clinical trials. Importantly, various methods of mathematical modelling and sterility testing are employed to ensure sterility. However, these methods are designed for materials with a low bioburden, such as food and pharmaceuticals. Consequently, current methods may not be reliable or applicable to estimate the irradiation dose required to sterilize microbiological preparations for vaccine purposes, where bioburden is deliberately high

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Mohr, Harald, Bernd Lambrecht, Anette Bayer, et al. "Basics of flow cytometry?based sterility testing of platelet concentrates." Transfusion 46, no. 1 (2006): 41–49. http://dx.doi.org/10.1111/j.1537-2995.2005.00668.x.

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JIMENEZ, LUIS, RAYMOND IGNAR, ROBERT D'AIELLO, and PAUL GRECH. "USE OF PCR ANALYSIS FOR STERILITY TESTING IN PHARMACEUTICAL ENVIRONMENTS." Journal of Rapid Methods and Automation in Microbiology 8, no. 1 (2000): 11–20. http://dx.doi.org/10.1111/j.1745-4581.2000.tb00343.x.

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Ramirez-Arcos, Sandra, Yuntong Kou, Lin Yang, et al. "Validation of sterility testing of cord blood: challenges and results." Transfusion 55, no. 8 (2015): 1985–92. http://dx.doi.org/10.1111/trf.13050.

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Gunar, O. V., L. V. Tsyganova, A. V. Dorenskaya, and N. A. Borisova. "Use of Isolation Technologies for Sterility Testing of Medicinal Products." Pharmaceutical Chemistry Journal 53, no. 12 (2020): 1188–90. http://dx.doi.org/10.1007/s11094-020-02145-7.

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Needham, Thomas E. "Parenteral Quality Control: Sterility, Pyrogen, Particulate, and Package Integrity Testing." Journal of Pharmaceutical Sciences 75, no. 1 (1986): 102–3. http://dx.doi.org/10.1002/jps.2600750126.

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Widmer, A. F., A. Houston, E. Bollinger, and R. P. Wenzel. "A new standard for sterility testing for autoclaved surgical trays." Journal of Hospital Infection 21, no. 4 (1992): 253–60. http://dx.doi.org/10.1016/0195-6701(92)90136-a.

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Gaudette, Kathryn E., and S. Jay Weaver. "Intraspinal Use of Morphine." Annals of Pharmacotherapy 37, no. 7-8 (2003): 1132–35. http://dx.doi.org/10.1345/aph.1c475.

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OBJECTIVE: To compare the different sterility standards and the cost issues involved when choosing an opioid product for intraspinal administration. DATA SOURCES: Literature accessed through MEDLINE and other Internet search engines (September 2002–April 2003) was evaluated. Key search terms included epidural/intrathecal, opioids, sterility, and compounding. DATA SYNTHESIS: Intraspinal use is prevalent in the area of pain management. Product selection is of utmost importance when administering through the intraspinal route. An evaluation of guidelines on sterility and a cost comparison were co

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Маматазим, к. Н., та А. К. Орозбекова. "Оценка эффективности использования коммерческих сред для исследования стерильности крови". Scientific and practical journal Healthcare of Kyrgyzstan, № 1 (3 червня 2025): 103–10. https://doi.org/10.51350/zdravkg2025.1.3.13.103.110.

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Введение. Исследование стерильности крови является ключевым эта пом в диагностике тяжелых инфекционных заболеваний, таких как сеп сис и бактериемия. Эффективность диагностики напрямую зависит от качества используемых питательных сред. В условиях роста антибио тикорезистентности и распространения внутрибольничных инфекций возрастает значимость своевременной и достоверной идентификации патогенов. Цель исследования. Оценить эффективность коммерческих питатель ных сред (TDR Resin Aerobic, TDR Resin Anaerobic, Среда ППА с МПБ) для исследования стерильности крови, с анализом их чувствительно сти, сп

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Domblides, Artur S. "Searching for sterility genes in bulb onion breeding accessions with the use of DNA markers." Vegetable crops of Russia, no. 5 (November 7, 2019): 15–19. http://dx.doi.org/10.18619/2072-9146-2019-5-15-19.

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Relevance. Sterility is a very important trait that is indispensable for hybrid production. Genetic factor underlying in plant sterility can be now identified in large plant populations by DNA markers with high effectiveness and reliability. The evaluation of such markers enables to define their current applicability in breeding program.Methods. The markers from different publications that had been successfully used were taken to test their effectiveness on 19 accessions of bulb onion (Allium cepa L.).Results. Mitochondrial genes 5’cob, orf725 and orfA501 and alleles of fertility restoring loc

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Li, Zhikang, Shannon R. M. Pinson, Andrew H. Paterson, William D. Park, and James W. Stansel. "Genetics of Hybrid Sterility and Hybrid Breakdown in an Intersubspecific Rice (Oryza sativa L.) Population." Genetics 145, no. 4 (1997): 1139–48. http://dx.doi.org/10.1093/genetics/145.4.1139.

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F1 hybrid sterility and “hybrid breakdown” of F2 and later generations in rice (Oryza sativa L.) are common and genetically complicated. We used a restriction fragment length polymorphism linkage map and F4 progeny testing to investigate hybrid sterility and hybrid breakdown in a cross between “widely compatible” O. sativa ssp. japonica cultivar Lemont from the Southern U.S. and ssp. indica cultivar Teqing from China. Our results implicate different genetic mechanisms in hybrid sterility and hybrid breakdown, respectively. Hybrid sterility appeared to be due to recombination within a number of

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Akers, Michael J., Glenn E. Wright, and Kimberly A. Carlson. "Sterility testing of antimicrobial-containing injectable solutions prepared in the pharmacy." American Journal of Health-System Pharmacy 48, no. 11 (1991): 2414–18. http://dx.doi.org/10.1093/ajhp/48.11.2414.

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Proud, D. W., and S. V. Sutton. "Development of a universal diluting fluid for membrane filtration sterility testing." Applied and Environmental Microbiology 58, no. 3 (1992): 1035–38. http://dx.doi.org/10.1128/aem.58.3.1035-1038.1992.

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D'Arbeloff, Nicholas C. "Improving the Integrity of Pharmaceutical Sterility Testing: A New Robotic Approach." Drug Development and Industrial Pharmacy 14, no. 18 (1988): 2733–40. http://dx.doi.org/10.3109/03639048809152044.

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Mohr, Harald, Bernd Lambrecht, Anette Bayer, et al. "Sterility testing of platelet concentrates prepared from deliberately infected blood donations." Transfusion 46, no. 3 (2006): 486–91. http://dx.doi.org/10.1111/j.1537-2995.2006.00747.x.

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Albano, Maria S., Nela-Ludy Dobrila, Rodica Ciubotariu, Margely DeLeon, Pablo Rubinstein, and Andromachi Scaradavou. "Evaluation of Alternative Samples for Sterility Testing of HPC-CB Products." Biology of Blood and Marrow Transplantation 19, no. 2 (2013): S194. http://dx.doi.org/10.1016/j.bbmt.2012.11.202.

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Nihtianov, S. N., G. P. Shterev, N. Petrov, and G. C. M. Meijer. "Impedance measurements with second-order harmonic oscillator for testing food sterility." IEEE Transactions on Instrumentation and Measurement 50, no. 4 (2001): 976–80. http://dx.doi.org/10.1109/19.948310.

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Roshchina, M. V., O. V. Gunar, and N. G. Sakhno. "Applicability of an Alternative Method for Sterility Testing of Medicinal Preparations." Pharmaceutical Chemistry Journal 51, no. 11 (2018): 1045–48. http://dx.doi.org/10.1007/s11094-018-1737-1.

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Sikder, S., and NK Paul. "Effects of post-anthesis heat stress on stem reserves mobilization, canopy temperature depression and floret sterility of wheat cultivars." Bangladesh Journal of Botany 39, no. 1 (2010): 51–55. http://dx.doi.org/10.3329/bjb.v39i1.5526.

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Testing of four heat tolerant (Gourab, Sourav, Kanchan and Shatabdi) and two heat sensitive (Sonora and Kalyansona) wheat cultivars under normal and late growing post-anthesis heat stress conditions revealed higher pre-anthesis stem reserves mobilization to the final grain weight and floret sterility in heat sensitive cultivars compared to heat tolerant cultivars. The heat tolerant cultivars showed higher canopy temperature depression than the heat sensitive cultivars in both the growing conditions indicating the higher ability of heat tolerant cultivars to maintain cooler canopy environment t

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Zakharenko, Lyudmila P., Dmitriy V. Petrovskii, Nataliya V. Dorogova, and Arcady A. Putilov. "Association between the Effects of High Temperature on Fertility and Sleep in Female Intra-Specific Hybrids of Drosophila melanogaster." Insects 12, no. 4 (2021): 336. http://dx.doi.org/10.3390/insects12040336.

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Humans and fruit flies demonstrate similarity in sleep-wake behavior, e.g., in the pattern of sleep disturbances caused by an exposure to high temperature. Although research has provided evidence for a clear connection between sleeping problems and infertility in women, very little is known regarding the mechanisms underlying this connection. Studies of dysgenic crosses of fruit flies revealed that an exposure to elevated temperature induces sterility in female intra-specific hybrids exclusively in one of two cross directions (progeny of Canton-S females crossed with Harwich males). Given the

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Van Demark, Robert E., Hillary A. Becker, Matthew C. Anderson, and Vanessa J. S. Smith. "Wide-Awake Anesthesia in the In-Office Procedure Room: Lessons Learned." HAND 13, no. 4 (2017): 481–85. http://dx.doi.org/10.1177/1558944717715120.

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Background: Wide-awake local anesthesia and no tourniquet (WALANT) has become more popular in hand surgery. Without a tourniquet, there is no need for preoperative testing or sedation. The use of lidocaine with epinephrine has allowed a larger variety of cases to be done safely in an outpatient setting instead of the hospital. “Minor field sterility,” which uses fewer drapes and tools to accomplish the same procedures, is a concept that is also gaining recognition. Methods: Investigation of hand surgeons performing a majority of cases using WALANT and minor field sterility was the beginning of

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Sukhanova, S. M., and N. E. Zakharova. "Microbial Quality of Dehydrated Media Used in the Sterility Testing of Immunobiological Medicinal Products." BIOpreparations. Prevention, Diagnosis, Treatment 18, no. 3 (2018): 191–97. http://dx.doi.org/10.30895/2221-996x-2018-18-3-191-197.

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Medicinal products fail sterility testing if visual observation shows the growth of microorganisms that manifests itself as turbidity, sedimentation, flocculation and other changes in the growth medium. A key factor allowing robust determination of changes in the culture that may be suspected of contamination is the quality of growth media used, namely their transparency, and absence of foreign matter detectable by microscopic examination of the growth media smears. The presence of such foreign matter makes it especially difficult to interpret the results of testing of immunobiological product

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Salem, Khaled F. M., Mousa A. Alghuthaymi, Abdelmoaty B. Elabd, Elsayed A. Elabsawy, and Hossam H. Mierah. "Prediction of Heterosis for Agronomic Traits in Half-Diallel Cross of Rice (Oryza sativa L.) under Drought Stress Using Microsatellite Markers." Plants 11, no. 12 (2022): 1532. http://dx.doi.org/10.3390/plants11121532.

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Rice breeders are encouraged to classify potential F1-hybrids without crossing all viable mixtures by testing depending on genetic distance due to lack of labor and time in yield trials. The goals of this research were to establish heterosis and investigate the relationship between genomic distance and agronomic attributes under drought. Half-diallel mating design, 28 F1′s and 8 parents were evaluated under drought and genotyped using 11 microsatellite markers. In total, 39 alleles were detected. Results indicated that the greatest heterotic effects for grain yield were observed in Sakha 103 ×

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Baume, Alex, Nick Coleman, and Philip Boughton. "Methods for Achieving Soft Tissue Scaffold Sterility." Journal of Biomimetics, Biomaterials and Tissue Engineering 4 (December 2009): 59–69. http://dx.doi.org/10.4028/www.scientific.net/jbbte.4.59.

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The manufacturing process for in vitro tissue culture products and medical devices relies on a validated sterilization route for ensuring product sterility, safety and performance. Two key aspects that contribute toward final sterilization validation are (1) the reliable estimation of product bioburden and (2) the development of a proficient sterile packaging system. Bioabsorbable composite systems and architecture of tissue scaffolds can lead to numerous challenges for bioburden testing and packaging design. This study is concerned with the development of bioburden assessment methods and pack

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Huang, Louis L., Ellen Ramas, Priti Prasad, et al. "Non-touch Aseptic technique Maintains Sterility of Antibiotic-Admixed peritoneal Dialysis Fluid." Peritoneal Dialysis International: Journal of the International Society for Peritoneal Dialysis 38, no. 1 (2018): 65–67. http://dx.doi.org/10.3747/pdi.2017.00106.

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There is a paucity of data on the sterility of peritoneal dialysis fluid (PDF) after drug admixture. International Society for Peritoneal Dialysis (ISPD) guidelines suggest using sterile technique when admixing antibiotics; however, the degree of sterility remains unclear. This issue is most pertinent when preparing take-home PDF for outpatient treatment of peritonitis. This study compares the sterility of PDF admixed with antibiotics using a non-touch aseptic technique (NTAT) versus sterile technique. Groups of 8 PDF mixtures (1.5% Dianeal or Icodextrin [Baxter International Inc., Spring Grov

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