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Sterile packaging

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
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
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
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
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
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...
February 8, 2018: Clinical Orthopaedics and related Research
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
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
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
Ana M C Santos, Mara S Doria, Luis Soares, António J Almeida, José C Menezes
Microbial quality control of non-sterile drug products is a concern to regulatory agencies and the pharmaceutical industry since the 1960's. 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 as well if such event occurs. To better manage this type of events and establish effective mitigation strategies, it is necessary to understand the microbial hazards involved in the manufacturing processes of non-sterile drug products, be able to evaluate their potential impact on final product quality and apply mitigation actions ...
December 14, 2017: PDA Journal of Pharmaceutical Science and Technology
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
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
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
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)
Fran L DeGrazio
A new major chapter dealing with container closure integrity (CCI) was released by the United States Pharmacopeial Convention (USP). Chapter <1207> provides a significant amount of education and guidance concerning test methodologies to prove that a system is integral and safe for use. The test method used is only one of the major considerations in approaching the challenge of proving an integral system. This paper takes a holistic review of all the major considerations needed in qualifying a new vial system for container closure integrity...
October 12, 2017: PDA Journal of Pharmaceutical Science and Technology
Saad Akhtar Khan, Muhammad Waqas, Usman T Siddiqui, Muhammad Shahzad Shamim, Karim Rizwan Nathani, Rashid Jooma, Faisal Mehmood
BACKGROUND: Postoperative meningitis is a growing cause of concern, especially with the evolution of multidrug-resistant organism. The authors evaluate the use of intraventricular/intrathecal (IVT/IT) antibiotics for postoperative gram-negative meningitis in patients whom intravenous antibiotics were ineffective. METHODS: Medical records were retrospectively reviewed and neurosurgery patients with gram-negative postoperative infection meningitis/ventriculitis were enrolled in the study...
2017: Surgical Neurology International
Clemencia Chaves López, Annalisa Serio, Costanza Montalvo, Cristina Ramirez, José Angel Peréz Álvarez, Antonello Paparella, Dino Mastrocola, Maria Martuscelli
Nisin is a lantibiotic exhibiting antimicrobial activity against a wide range of Gram-positive bacteria, or some Gram-negative bacteria when used in combination with other preservative agents. The objective of the present work was to study the effect of nisin treatment on biogenic amines occurrence and shelf life of refrigerated (4 °C) vacuum packaged rainbow trout samples. For this purpose samples were divided in two batches: the experimental batch (CB-N), consisting of samples immersed in sterilized broth formulated with soy milk 1...
September 2017: Journal of Food Science and Technology
Martin A Koyle, Naif AlQarni, Rakan Odeh, Hissan Butt, Mohammed M Alkahtani, Louis Konstant, Lisa Pendergast, Leah C C Koyle, G Ross Baker
AIM: To standardize and reduce surgical instrumentation by >25% within a 9-month period for pediatric inguinal hernia repair (PIHR), using "improvement science" methodology. METHODS: We prospectively evaluated instruments used for PIHR in 56 consecutive cases by individual surgeons across two separate subspecialties, pediatric surgery (S) and pediatric urology (U), to measure actual number of instruments used compared with existing practice based on preference cards...
September 8, 2017: Journal of Pediatric Urology
Jeffrey R Vieregg, Steven J Martin, Adam P Breeland, Christopher M Weikart, Matthew V Tirrell
For many years, glass has been the default material for parenteral packaging, but the development of advanced plastics such as cyclic olefin polymers (COP) and the rapidly increasing importance of biologic drugs have provided new choices, as well as more stringent performance requirements. In particular, many biologics must be stored at non-neutral pH, where glass is susceptible to hydrolysis, metal extraction, and delamination. Plastic containers are not susceptible to these problems, but suffer from higher gas permeability and a propensity for sterilization-induced radical generation, heightening the risk of oxidative damage to sensitive drugs...
September 19, 2017: PDA Journal of Pharmaceutical Science and Technology
Robert A Schaut, Kyle C Hoff, Steven E Demartino, William K Denson, Ronald L Verkleeren
An essential role of packaging material for the storage and delivery of drug products is to provide adequate protection against contamination and loss of sterility. This is especially important for parenteral containers, as lack of sterility or contamination can result in serious adverse events including death. Nonetheless, cracked parenteral containers are an important source of container integrity failures for injectable drugs and pose a serious risk for patients. Despite significant investments in inspection technology, each year many injectable drugs are investigated and recalled for sterility risks associated with cracked borosilicate containers...
November 2017: PDA Journal of Pharmaceutical Science and Technology
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