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https://www.readbyqxmd.com/read/28645998/stability-of-tacrolimus-ophthalmic-solution
#1
Carlos Ezquer-Garin, Rafael Ferriols-Lisart, Manuel Alós-Almiñana
PURPOSE: The stability of 0.3-mg/mL tacrolimus ophthalmic solution at different storage temperatures was studied. METHODS: A sterile ophthalmic solution of 0.3 mg/mL tacrolimus was prepared in triplicate under aseptic conditions by diluting tacrolimus in eye drops. Three aliquots of this solution were transferred into polypropylene bottles and stored at 25, 2-8, or -15 to -25 °C. Samples were collected immediately after preparation and at selected time points and assayed in triplicate using high-performance liquid chromatography (HPLC)...
July 1, 2017: American Journal of Health-system Pharmacy: AJHP
https://www.readbyqxmd.com/read/28624776/mold-control-and-detection-in-biological-drug-substance-manufacturing-facilities-an-industry-perspective
#2
Anita Bawa, Sophia Asefi, Stephanie Ramsey, Christine Arbesser-Rastburg, Mousumi Paul, Francisco Leira, Kim McFarland, Tracy Landeryou, Bindhu Reddy, Marie Murphy, Barbara Daddis, David Baine, Derek Willison-Parry
The biopharmaceutical industry produces non-sterile and/or low-bioburden intermediates and bulk biologics (i.e. Drug Substances) using bioburden controlled processes in accordance to Q7A and Annex 2. In many cases, single mold isolation events have received a high level of scrutiny; the goal of this paper is to challenge this paradigm and provide the rationale for an enhanced control approach that focuses on trending of mold species as microbial indicators rather than on single isolation events. Molds, can also be part (in much lower numbers) of the normal microbial population of a biologics manufacturing facility and, therefore, mold isolation is not an unexpected event in non-aseptic processing environments...
June 16, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28616079/surgical-site-infection-and-its-associated-factors-following-cesarean-section-a-cross-sectional-study-from-a-public-hospital-in-ethiopia
#3
Kelemu Abebe Gelaw, Amlaku Mulat Aweke, Feleke Hailemichael Astawesegn, Birhanu Wondimeneh Demissie, Liknaw Bewket Zeleke
BACKGROUND: A cesarean section is a surgical procedure in which incisions are made through a woman's abdomen and uterus to deliver her baby. Surgical site infections are a common surgical complication among patients delivered with cesarean section. Further it caused to increase maternal morbidity, stay of hospital and the cost of treatment. METHODS: Hospital based cross-sectional study was conducted to assess the magnitude of surgical site infection following cesarean Site Infections and its associated factors at Lemlem Karl hospital July 1, 2013 to June 30, 2016...
2017: Patient Safety in Surgery
https://www.readbyqxmd.com/read/28605693/evaluation-of-flunixin-meglumine-pour-on-administration-on-prostaglandin-e2-concentration-in-inflammatory-exudate-after-induction-of-inflammation-in-cattle
#4
Julien Thiry, René Fournier, Olivier Roy, Mathias Catala
The effect of flunixin transdermal pour-on solution (Finadyne® Transdermal; MSD Animal Health) on prostaglandin E2 (PGE2) synthesis in bovine inflammatory exudate was evaluated in a tissue cage model of acute inflammation. Twelve calves were randomly allocated to two-treatment groups over two sequences. Three weeks prior to the first period, sterile hollow perforated polyethylene balls were surgically embedded in the subcutis at four distinct sites in each animal. On the first day of each period, an aseptic inflammation was induced by injecting 0...
April 20, 2017: Research in Veterinary Science
https://www.readbyqxmd.com/read/28589874/effects-of-time-and-storage-conditions-on-the-chemical-and-microbiologic-stability-of-diluted-buprenorphine-for-injection
#5
Johnathan M DenHerder, Ralph L Reed, Jennifer L Sargent, Gerd Bobe, Jan F Stevens, Helen E Diggs
Buprenorphine is a partial μ-opioid agonist used for analgesia. Due to the small size of laboratory rodents, buprenorphineHCl is typically diluted 10- or 20-fold with a sterile diluent, such as saline, for accurate dosing. Protocols for preparing andstoring diluted buprenorphine vary by institution, and little published information is available regarding stability andbeyond-use dating of specific buprenorphine preparations. The purpose of this study was to determine the chemical andmicrobiologic stability of diluted buprenorphine stored for a maximum of 180 d...
June 6, 2017: Journal of the American Association for Laboratory Animal Science: JAALAS
https://www.readbyqxmd.com/read/28575999/sterilization-of-silicone-based-hydrogels-for-biomedical-application-using-ozone-gas-comparison-with-conventional-techniques
#6
Raquel Galante, Daniela Ghisleni, Patrizia Paradiso, Vitor D Alves, Terezinha J A Pinto, Rogério Colaço, Ana Paula Serro
Sterilization of hydrogels is challenging due to their often reported sensitivity to conventional methods involving heat or radiation. Although aseptic manufacturing is a possibility, terminal sterilization is safer in biological terms, leading to a higher overall efficiency, and thus should be used whenever it is possible. The main goal of this work was to study the applicability of an innovative ozone gas terminal sterilization method for silicone-based hydrogels and compare its efficacy and effects with those of traditional sterilization methods: steam heat and gamma irradiation...
September 1, 2017: Materials Science & Engineering. C, Materials for Biological Applications
https://www.readbyqxmd.com/read/28560952/effects-of-time-and-storage-conditions-on-the-chemical-and-microbiologic-stability-of-diluted-buprenorphine-for-injection
#7
Ralph L Reed, Johnathan M DenHerder, Jennifer L Sargent, Gerd Bobe, J Fred Stevens, Helen E Diggs
Buprenorphine is a partial μ-opioid agonist used for analgesia. Due to the small size of laboratory rodents, buprenorphineHCl is typically diluted 10- or 20-fold with a sterile diluent, such as saline, for accurate dosing. Protocols for preparing andstoring diluted buprenorphine vary by institution, and little published information is available regarding stability and beyond-use dating of specific buprenorphine preparations. The purpose of this study was to determine the chemical and microbiologic stability of diluted buprenorphine stored for a maximum of 180 d...
May 30, 2017: Journal of the American Association for Laboratory Animal Science: JAALAS
https://www.readbyqxmd.com/read/28544163/the-impact-of-clinical-practice-on-the-outcome-of-central-venous-access-devices-in-children-with-haemophilia
#8
K Khair, S Ranta, A Thomas, K Lindvall
INTRODUCTION: Central venous access devices facilitate home treatment in boys with haemophilia. These are usually fully implanted lines, referred to as ports. Caregivers are taught to manage the port using sterile techniques and maintaining patency by flushing with saline or heparin solution. National and international guidelines for the home care of ports are lacking. AIM: To evaluate if infection or occlusion rates differ between home care regimens used for ports in children with haemophilia...
May 24, 2017: Haemophilia: the Official Journal of the World Federation of Hemophilia
https://www.readbyqxmd.com/read/28532076/sustained-drug-release-from-surface-modified-uhmwpe-for-acetabular-cup-lining-in-total-hip-implant
#9
R Manoj Kumar, Pallavi Gupta, Sandan Kumar Sharma, Akshat Mittal, Manish Shekhar, Vijayesh Kumar, B V Manoj Kumar, Partha Roy, Debrupa Lahiri
Despite sterilization and aseptic procedure, bacterial infection remains a key challenge in total hip arthroplasties. This fact emphasizes the urgent need for development of new implant systems, which should releases the drug in a controlled manner without sparing its mechanical and tribological properties. In this study, the lining material of the acetabular cup, in total hip implant, has been modified for sustained release of drugs, which should be available throughout the site of implantation to fight the post-operation bacterial infection...
August 1, 2017: Materials Science & Engineering. C, Materials for Biological Applications
https://www.readbyqxmd.com/read/28511502/comparative-evaluation-of-three-herbal-solutions-on-the-disinfection-of-guttapercha-cones-an-in-vitro-study
#10
Pratap Kumar Mukka, Samba Shiva Rao Pola, Nanda Kumar Kommineni, Mayuri Sailaja Pachalla, Anand Ramtheerth Karne, Karthik Labishetty, Supriya Kommineni, Praveen Chilakabathini
INTRODUCTION: Guttapercha (GP) cones are usually supplied in aseptic, sealed packages from the manufacturers, but once exposed to the dental office environment or even by handling; they can be contaminated by a number of microorganisms. Supplementary decontamination of GP cones is critical. As they cannot be sterilized by moist or dry heat, cold sterilization, using disinfectants should be used. AIM: The aim of the study was to evaluate rapid, reliable, convenient and effective method of disinfection of GP cones using readily available herbal solutions such as Aloevera Juice, Amla Juice and Pancha Tulsi...
March 2017: Journal of Clinical and Diagnostic Research: JCDR
https://www.readbyqxmd.com/read/28454613/back-to-basics-sterile-technique
#11
Lisa Spruce
Sterile technique is an essential patient safety principle that reduces the risk of microbial transmission to patients during surgery. The ability to establish and maintain a sterile environment is an important skill for all perioperative team members. Understanding the principles of sterile technique is crucial for anyone entering the perioperative environment. This Back to Basics article reviews sterile technique and the importance of all perioperative team members adhering to aseptic principles.
May 2017: AORN Journal
https://www.readbyqxmd.com/read/28450886/moderate-alkali-thermophilic-ethanologenesis-by-locally-isolated-bacillus-licheniformis-from-pakistan-employing-sugarcane-bagasse-a-comparative-aspect-of-aseptic-and-non-aseptic-fermentations
#12
Qurat-Ul-Ain Ahmad, Shang-Tian Yang, Maleeha Manzoor, Javed Iqbal Qazi
BACKGROUND: Biofuels obtained from first-generation (1G) sugars-starch streams have been proven unsustainable as their constant consumption is not only significantly costly for commercial scale production systems, but it could potentially lead to problems associated with extortionate food items for human usage. In this regard, biofuels' production in alkali-thermophilic environs from second-generation (2G) bio-waste would not only be markedly feasible, but these extreme conditions might be able to sustain aseptic fermentations without spending much for sterilization...
2017: Biotechnology for Biofuels
https://www.readbyqxmd.com/read/28447477/simultaneous-visualization-of-hydrogen-peroxide-and-water-concentrations-using-photofragmentation-laser-induced-fluorescence
#13
Kajsa Larsson, Marcus Aldén, Joakim Bood
A concept based on photofragmentation laser-induced fluorescence (PFLIF) is for the first time demonstrated for simultaneous detection of hydrogen peroxide (H2O2) and water (H2O) vapor in various mixtures containing the two constituents in a bath of argon gas. A photolysis laser pulse at 248 nm dissociates H2O2 into OH fragments, whereupon a probe pulse, delayed 100 ns and tuned to an absorption line in the A(2)Σ(+) (v = 1) ← X(2)Π(v = 0) band of OH near 282 nm, induces fluorescence. The total OH fluorescence reflects the H2O2 concentration, while its spectral shape is utilized to determine the H2O concentration via a model predicting the ratio between the fluorescence intensities of the A(2)Σ(+) (v = 1) → X(2)Π(v = 1) and the A(2)Σ(+) (v = 0) → X(2)Π(v = 0) bands...
January 1, 2017: Applied Spectroscopy
https://www.readbyqxmd.com/read/28433042/-alarmins-and-surgical-injury
#14
J Máca, M Peteja
Surgical intervention is an inseparable part of the management of serious surgical disease. However, surgery also presents a potential risk related to the so-called surgical injury causing immune response. When dysregulated the immune activation is able to cause local complications (i.e. wound dehiscence, impaired healing). Systemic decompartmentization of the immunologic disturbance can negatively influence long-term outcomes (i.e. hospital length of stay, mortality). Due to aseptic conditions in the operating room, such an immune activation is almost always of sterile nature...
2017: Rozhledy V Chirurgii: Měsíčník Československé Chirurgické Společnosti
https://www.readbyqxmd.com/read/28416646/increasing-patient-safety-by-closing-the-sterile-production-gap-part-3-moist-heat-resistance-of-bioburden
#15
James P Agalloco
Terminal sterilization is considered the preferred means for the production of sterile drug products as it affords enhanced safety for the patient because the formulation is sterilized in its sealed, final container. Despite the obvious patient benefits, the use of terminal sterilization is artificially constrained by unreasonable expectations for the minimum time-temperature process to be used. The core misunderstanding with terminal sterilization is the notion that destruction of a high population of a resistant biological indicator microorganism is required...
April 17, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28410135/custom-built-tools-for-the-study-of-deer-antler-biology
#16
Wenhui Chu, Haiping Zhao, Junde Li, Chunyi Li
Deer antlers can be developed into multiple novel models to study growth and development of tissues for biomedical research. To facilitate this process, we have invented and further refined five custom-built tools through three decades of antler research. These are: 1. Pedicle growth detector to pinpoint the timing when pedicle growth is initiated, thus stimuli for pedicle and first antler formation can be investigated and identified. 2. Thin periosteum slice cutter to thinly slice (0.2mm or 0.7 mm thick) a whole piece of antlerogenic periosteum (AP) or pedicle periosteum (PP), which facilitates gene delivery into cells resident in these tissues, thus making transgenic antlers possible...
June 1, 2017: Frontiers in Bioscience (Landmark Edition)
https://www.readbyqxmd.com/read/28361272/sterilization-of-blow-fly-eggs-chrysomya-megacephala-and-lucilia-cuprina-diptera-calliphoridae-for-maggot-debridement-therapy-application
#17
Kwankamol Limsopatham, Phadungkiat Khamnoi, Kabkaew L Sukontason, Dheerawan Boonyawan, Tarinee Chaiwong, Kom Sukontason
Maggot debridement therapy (MDT) is an application of sterile laboratory-reared blow fly larvae to remove necrotic tissue and disinfect wounds for medical conditions. For effective application, the blow fly larvae used in the wound treatment are required to be in aseptic condition. Here, we report the results of a detailed assessment of bacteria and fungi isolated from the eggs of two blow fly species, Chrysomya megacephala (F.) and Lucilia cuprina (Wiedemann) before and after sterilization by disinfectants Chlorhex-C, povidone-iodine, and sodium hypochlorite...
March 30, 2017: Parasitology Research
https://www.readbyqxmd.com/read/28349758/use-of-natural-user-interfaces-for-image-navigation-during-laparoscopic-surgery-initial-experience
#18
Francisco M Sánchez-Margallo, Juan A Sánchez-Margallo, José L Moyano-Cuevas, Eva María Pérez, Juan Maestre
BACKGROUND: Surgical environments require special aseptic conditions for direct interaction with the preoperative images. We aim to test the feasibility of using a set of gesture control sensors combined with voice control to interact in a sterile manner with preoperative information and an integrated operating room (OR) during laparoscopic surgery. MATERIAL AND METHODS: Two hepatectomies and two partial nephrectomies were performed by three experienced surgeons in a porcine model...
March 28, 2017: Minimally Invasive Therapy & Allied Technologies: MITAT
https://www.readbyqxmd.com/read/28337488/supercritical-carbon-dioxide-based-sterilization-of-decellularized-heart-valves
#19
Ryan S Hennessy, Soumen Jana, Brandon J Tefft, Meghana R Helder, Melissa D Young, Rebecca R Hennessy, Nicholas J Stoyles, Amir Lerman
OBJECTIVE: The goal of this research project encompasses finding the most efficient and effective method of decellularized tissue sterilization. BACKGROUND: Aortic tissue grafts have been utilized to repair damaged or diseased valves. Although, the tissues for grafting are collected aseptically, it does not eradicate the risk of contamination nor disease transfer. Thus, sterilization of grafts is mandatory. Several techniques have been applied to sterilize grafts; however, each technique shows drawbacks...
February 2017: JACC. Basic to Translational Science
https://www.readbyqxmd.com/read/28333673/choosing-a-vial-processing-line-for-aseptic-compounding-part-1
#20
REVIEW
Shaun Noorian, Navid Vahedi
Equipment systems that enable compliance with stringent state and federal compounding requirements are a topic of increasing interest to U.S. pharmacists. Of those equipment types, an aseptic vial processing line offers unique benefits (especially to 503B compounding pharmacies and small contract manufacturers of aseptic pilot-size batches) if the volume of sterile preparations dispensed offsets the cost of purchase, installation, and maintenance. In this article, the reasons for and the process of selecting an aseptic vial processing line for use in 2 independent 503B compounding pharmacies are presented, the operation of our choice of equipment is described, and specifications for the components of that line are listed...
July 2016: International Journal of Pharmaceutical Compounding
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