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Sterile packaging

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https://www.readbyqxmd.com/read/29708242/co-delivery-of-timolol-and-hyaluronic-acid-from-semi-circular-ring-implanted-contact-lenses-for-the-treatment-of-glaucoma-in-vitro-and-in-vivo-evaluation
#1
Ankita R Desai, Furqan A Maulvi, Mihir M Pandya, Ketan M Ranch, Bhavin A Vyas, Shailesh A Shah, Dinesh O Shah
Glaucoma is a chronic disease, which is currently treated using frequent high dose applications of an eye drop solution; this method is tedious, and most of patients are non-compliant to it. Contact lenses are emerging as a convenient option to sustain the release of ophthalmic drugs. However, the incorporation of a drug/formulation changes the optical and physical properties of contact lenses. Contact lens users have also reported pink eye syndrome; this makes contact lenses unsuitable to be accepted as a medical device...
April 30, 2018: Biomaterials Science
https://www.readbyqxmd.com/read/29659450/aseptic-freeze-dried-vs-sterile-wet-packaged-human-cadaveric-acellular-dermal-matrix-adm-in-immediate-tissue-expander-breast-reconstruction-a-propensity-score-analysis-study
#2
Summer E Hanson, Jesse D Meaike, Jesse C Selber, Jun Liu, Liang Li, Victor J Hassid, Donald P Baumann, Charles E Butler, Patrick B Garvey
BACKGROUND: Although multiple acellular dermal matrix (ADM) sources exist, it is unclear how ADM processing impacts complication rates. We compared complications between two preparations of human cadaveric ADM (freeze dried [hADM-FD] and ready to use [hADM-RTU]) in immediate tissue expander (TE) breast reconstruction to analyze the effect of processing on complications. HADM-FD is aseptic while hADM-RTU is sterilized and wet-packaged. METHODS: We retrospectively reviewed all TE breast reconstructions with hADM-FD or hADM-RTU at a single center between 2006 and 2016...
January 20, 2018: Plastic and Reconstructive Surgery
https://www.readbyqxmd.com/read/29581597/stability-of-2-mg-ml-adenosine-solution-in-polyvinyl-chloride-and-polyolefin-infusion-bags
#3
Michael DeAngelis, Alexander Ferrara, Kaleigh Gregory, Kimberly Zammit, Fang Zhao
Adenosine is a potent endogenous mediator of vasodilation. Compounded sterile solutions of adenosine are used in cardiac catheterization lab to perform stress tests on the heart. These tests are used to determine the fractional flow reserve (FFR) and are commonly used in the management and diagnosis of cardiovascular conditions. The purpose of this study was to assess the physical and chemical stability of 2 mg/mL adenosine in 0.9% Sodium Chloride Injection, USP in polyvinyl chloride [PVC]) and polyolefin infusion bags stored at room temperature (20°C-25°C) and under refrigeration (2°C-8°C)...
April 2018: Hospital Pharmacy
https://www.readbyqxmd.com/read/29580509/microfiltration-and-ultra-high-pressure-homogenization-for-extending-the-shelf-storage-stability-of-uht-milk
#4
P D'Incecco, V Rosi, G Cabassi, J A Hogenboom, L Pellegrino
Fat separation, gelation or sedimentation of UHT milk during shelf-storage represent instability phenomena causing the product rejection by consumers. Stability of UHT milk is of increasing concern because access to emerging markets currently implies for this product to be stable during shipping and prolonged storage, up to 12 months. The role of microfiltration prior to UHT process in avoiding or retarding the gelation or sediment formation was studied by comparing microfiltered UHT milk to conventional UHT milk...
May 2018: Food Research International
https://www.readbyqxmd.com/read/29579817/sterility-and-safety-validation-for-transport-packaging-of-organs-and-tissues
#5
M Cobos, L Trunzo, M V Vogt, O Romero, C Anessi, J Pachado, M N Ciávaro, C Horak, M C Bacqué
The bags used in the transport of organs and tissues must be sterile, nontoxic, pyrogen free, and must serve as a barrier throughout their useful life. The goal of this study was to show the sterility, safety, and functionality of the bags subjected to irradiation, through validated procedures and techniques. The selected sterilization method was the use of gamma radiation. The sterilization dose was determined based on validated standards for the sterilization of medical products, ISO 11137-2: 2013 and ISO/TS 13004: 2013, using the Verification Dose Maximum method on samples belonging to 3 manufacturing lots...
March 2018: Transplantation Proceedings
https://www.readbyqxmd.com/read/29574970/migration-study-of-butylated-hydroxytoluene-and-irganox-1010-from-polypropylene-treated-with-severe-processing-conditions
#6
Kyungmo Kang, Yoonjee Chang, Jae Chun Choi, Se-Jong Park, Jaejoon Han
Safety concerns have emerged over the increased use of polypropylene (PP) in food-packaging markets. Some antioxidants in PP can migrate to foods and cause undesirable effects in humans. In this study, migration behaviors of butylated hydroxytoluene (BHT) and Irganox 1010 (I-1010) in PP sheets were determined according to the US FDA migration test conditions. In particular, we tested the effects of severe conditions of food processing and storage, such as autoclave heating (sterilization at about 121 °C), microwave radiation (700 W), and deep freezing (-30 °C) on migration of antioxidants...
March 25, 2018: Journal of Food Science
https://www.readbyqxmd.com/read/29514423/identification-and-study-of-the-behavior-of-s-aureus-and-s-epidermidis-in-fresh-and-frozen-strawberries
#7
Izabela Steinka, Anita Kukułowicz
BACKGROUND: Methicillin-Resistant Staphylococcus aureus (MRSA), which is resistant to many antibiotics, creates a serious problem for human health if present in food. This study aimed to assess the quality of commercially-available fresh and frozen strawberries and to compare the behavior of staphylococci in these fruits as affected by the temperature of freezing. METHODS: The research material included different species of fresh strawberries and strawberries frozen with the fluidization method to –40°C and packaged in an industrial environment...
January 2018: Acta Scientiarum Polonorum. Technologia Alimentaria
https://www.readbyqxmd.com/read/29501060/consensus-seo-sefh-of-recommendations-for-use-and-compounding-of-ophthalmic-preparations
#8
Raquel Fuentes-Irigoyen, Ana María Martín de Rosales Cabrera, Ana Cristina Riestra, María Nieves Vila, Carmela Dávila-Pousa, José María Alonso Herreros, Carmen López-Cabezas, Carmen Cañete, María Sagrario Pernía-López, Marta Garcia-Palomo, Pedro Arriola Villalobos, Lucía Ibares-Frías, José Luís Urcelay Segura, Jacobo Ramón Yañez Martínez
There are many medicinal products that, although having shown efficacy and  safety in different ophthalmological indications, they are not authorized or  commercially available for ophthalmic administration. This implies, on one hand,  that they must be used according to legislation that regulates the availability of  medicines in special situations and, on the other hand, that they must be  prepared in the pharmacy services for ophthalmic administration, according to  quality criteria to ensure its effectiveness, stability and sterility...
March 1, 2018: Farmacia Hospitalaria
https://www.readbyqxmd.com/read/29495334/combined-effect-of-ultrasound-stimulations-and-autoclaving-on-the-enhancement-of-antibacterial-activity-of-zno-and-sio%C3%A2-zno-nanoparticles
#9
Hajer Rokbani, France Daigle, Abdellah Ajji
This study investigates the antibacterial activity (ABA) of suspensions of pure ZnO nanoparticles (ZnO-NPs) and mesoporous silica doped with ZnO (ZnO-UVM7), as well as electrospun nanofibers containing those nanoparticles. The minimum inhibitory concentration (MIC) and minimum bactericidal concentration (MBC) of these two materials were also determined under the same conditions. The results showed a concentration-dependent effect of antibacterial nanoparticles on the viability of Escherichia coli ( E. coli )...
February 25, 2018: Nanomaterials
https://www.readbyqxmd.com/read/29478716/-study-of-the-deadlines-for-the-use-after-sterilization-of-hot-sealable-bags-and-sheaths
#10
Z Leguay, E Figueiredo, L Evrillus, V Jacques-Terracol, M Le Verger
INTRODUCTION: The choice of packaging is crucial for the sterility of a reusable medical device. The use-by dates for sterile barrier systems (SBSs) are currently determined solely on the basis of an empirical rating scale developed in 1985. The objective of our work is to validate in a scientific way this deadline for the use of SBS for heat-sealable sleeves and bags, with protective packaging. MATERIALS AND METHODS: Thirty SBSs were tested after different storage periods ; six, nine and twelve months...
February 22, 2018: Annales Pharmaceutiques Françaises
https://www.readbyqxmd.com/read/29434400/evaluation-of-gamma-radiation-inactivation-of-a-bioterrorism-agent-bacillus-anthracis-spores-on-different-materials
#11
Mesut Ortatatli, Kadir Canitez, Sermet Sezigen, Ruşen Koray Eyison, Levent Kenar
Decontamination of suspected packages, such as sealed envelopes, liquids and tools that are likely contaminated with biological agents is of great importance. In this study, we aimed to determine the gamma radiation dose required for the decontamination of paper, fabric and liquid materials without causing any damage to the structure of these materials. Each study group included 11 pieces of paper, fabric and sterile saline contaminated with 0.8 × 105 virulent Bacillus anthracis (B. anthracis ) spores. These specimens were exposed to doses of 5...
March 2018: Indian Journal of Microbiology
https://www.readbyqxmd.com/read/29432266/looking-for-holes-in-sterile-wrapping-how-accurate-are-we
#12
Christopher H Rashidifard, Hani A Mayassi, Chelsea M Bush, Brian M Opalacz, Mark W Richardson, Paul M Muccino, Thomas G DiPasquale
BACKGROUND: Defects in sterile surgical wrapping are identified by the presence of holes through which light can be seen. However, it is unknown how reliably the human eye can detect these defects. QUESTIONS/PURPOSES: The purpose of this study was to determine (1) how often holes in sterile packaging of various sizes could be detected; and (2) whether differences in lighting, experience level of the observer, or time spent inspecting the packaging were associated with improved likelihood of detection of holes in sterile packaging...
May 2018: Clinical Orthopaedics and related Research
https://www.readbyqxmd.com/read/29419605/ceftaroline-for-suspected-or-confirmed-invasive-methicillin-resistant-staphylococcus-aureus-a-pharmacokinetic-case-series
#13
Jeffrey J Cies, Wayne S Moore, Adela Enache, Arun Chopra
OBJECTIVES: To describe the ceftaroline pharmacokinetics in critically ill children treated for suspected or confirmed methicillin-resistant Staphylococcus aureus infections, including blood stream infection and describe the microbiological and clinical outcomes. DESIGN: Retrospective electronic medical record review. SETTINGS: Free-standing tertiary/quaternary pediatric children's hospital. PATIENTS: Critically ill children receiving ceftaroline monotherapy or combination therapy for suspected or confirmed methicillin-resistant S...
February 6, 2018: Pediatric Critical Care Medicine
https://www.readbyqxmd.com/read/29409447/microbial-contaminants-isolated-from-items-and-work-surfaces-in-the-post-operative-ward-at-kawolo-general-hospital-uganda
#14
Ivan Sserwadda, Mathew Lukenge, Bashir Mwambi, Gerald Mboowa, Apollo Walusimbi, Farouk Segujja
BACKGROUND: Nosocomial infections are a major setback in the healthcare delivery system especially in developing countries due to the limited resources. The roles played by medical care equipment and work surfaces in the transmission of such organisms have inevitably contributed to the elevated mortality, morbidity and antibiotic resistances. METHODS: A total 138 samples were collected during the study from Kawolo general hospital. Swab samples were collected from various work surfaces and fomites which consisted of; beds, sink taps, infusion stands, switches, work tables and scissors...
February 6, 2018: BMC Infectious Diseases
https://www.readbyqxmd.com/read/29389632/evaluation-of-spoilage-potential-and-volatile-metabolites-production-by-shewanella-baltica-isolated-from-modified-atmosphere-packaged-live-mussels
#15
Olumide A Odeyemi, Christopher M Burke, Christopher J S Bolch, Roger Stanley
Under the current commercial practice, live mussels only have 10days' shelf-life. Observed spoilage indices reduce consumers' acceptance, palatability and shelf-life of modified atmosphere packaged (MAP) live mussels. The aims of this study are to isolate specific spoilage bacteria from modified atmosphere packaged live mussels, evaluate isolates for microbial spoilage indices using qualitative methods and volatile metabolites production. Forty-six hydrogen sulphide producing bacteria were isolated and evaluated for trimethylamine n-oxide (TMAO) reduction, proteolytic and lipolytic activities and hydrogen sulphide production...
January 2018: Food Research International
https://www.readbyqxmd.com/read/29242394/a-qrm-discussion-of-microbial-contamination-of-non-sterile-drug-products-using-fda-and-ema-warning-letters-recorded-between-2008-and-2016
#16
Ana M C Santos, Mara S Doria, Luís Meirinhos-Soares, António J Almeida, José C Menezes
Microbial quality control of non-sterile drug products has been a concern to regulatory agencies and the pharmaceutical industry since the 1960s. Despite being an old challenge to companies, microbial contamination still affects a high number of manufacturers of non-sterile products. Consequences go well beyond the obvious direct costs related to batch rejections or product recalls, as human lives and a company's reputation are significantly impacted if such events occur. To better manage risk and establish effective mitigation strategies, it is necessary to understand the microbial hazards involved in non-sterile drug products manufacturing, be able to evaluate their potential impact on final product quality, and apply mitigation actions...
January 2018: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/29235842/mussel-inspired-synthesis-of-nir-responsive-and-biocompatible-ag-graphene-2d-nanoagents-for-versatile-bacterial-disinfections
#17
Xin Fan, Fan Yang, Chuanxiong Nie, Ye Yang, Haifeng Ji, Chao He, Chong Cheng, Changsheng Zhao
Pathogenic bacterial infection has been becoming a global threat toward people's health, especially the massive usage of antibiotics due to the lack of antibacterial agents with less side effects. Developing new nanoagents to fight pathogenic bacteria has provided enormous new possibilities in the treatment of bacterial infections, such as graphene-based two-dimensional (2D) antibacterial nanoagents with different bacterial inhibition capabilities; however, mussel-inspired design of near-infrared (NIR)-responsive and biocompatible Ag-graphene nanoagents possessing efficient and versatile bacterial disinfection activities have rarely been reported...
January 10, 2018: ACS Applied Materials & Interfaces
https://www.readbyqxmd.com/read/29216619/stability-of-dalteparin-1-000-unit-ml-in-0-9-sodium-chloride-for-injection-in-polypropylene-syringes
#18
Kylian Kirkham, Jessica M Munson, Susan V McCluskey, Kevin K Graner
The stability of dalteparin 1,000 units/mL in 0.9% sodium chloride for injection stored in polypropylene syringes under refrigeration was examined. Dalteparin 1,000-units/mL syringes were prepared by adding 9 mL of 0.9% sodium chloride for injection to 1 mL of dalteparin sodium 10,000 unit/mL from commercial single-use syringes. Compounded solutions in 0.5-mL aliquots were transferred to 1-mL polypropylene syringes and sealed with a Luer lock tip cap and stored at refrigerated temperatures (2°C to 8°C) with ambient fluorescent light exposure...
September 2017: International Journal of Pharmaceutical Compounding
https://www.readbyqxmd.com/read/29200471/implementing-the-sterile-insect-technique-with-rna-interference-a-review
#19
Michael Darrington, Tamas Dalmay, Neil I Morrison, Tracey Chapman
We review RNA interference (RNAi) of insect pests and its potential for implementing sterile insect technique (SIT)-related control. The molecular mechanisms that support RNAi in pest species are reviewed in detail, drawing on literature from a range of species including Drosophila melanogaster Meigen and Homo sapiens L. The underlying genes that enable RNAi are generally conserved across taxa, although variance exists in both their form and function. RNAi represents a plausible, non-GM system for targeting populations of insects for control purposes, if RNAi effector molecules can be delivered environmentally (eRNAi)...
September 2017: Entomologia Experimentalis et Applicata
https://www.readbyqxmd.com/read/29156617/optimum-thermal-processing-for-extended-shelf-life-esl-milk
#20
REVIEW
Hilton Deeth
Extended shelf-life (ESL) or ultra-pasteurized milk is produced by thermal processing using conditions between those used for traditional high-temperature, short-time (HTST) pasteurization and those used for ultra-high-temperature (UHT) sterilization. It should have a refrigerated shelf-life of more than 30 days. To achieve this, the thermal processing has to be quite intense. The challenge is to produce a product that has high bacteriological quality and safety but also very good organoleptic characteristics...
November 20, 2017: Foods (Basel, Switzerland)
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