keyword
MENU ▼
Read by QxMD icon Read
search

Sterile packaging

keyword
https://www.readbyqxmd.com/read/29242394/a-qrm-discussion-of-microbial-contamination-of-non-sterile-drug-products-using-fda-s-and-ema-s-warning-letters-between-2008-and-2016
#1
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
https://www.readbyqxmd.com/read/29235842/mussel-inspired-synthesis-of-nir-responsive-and-biocompatible-ag-graphene-2d-nano-agents-for-versatile-bacterial-disinfections
#2
Xin Fan, Fan Yang, Chuanxiong Nie, Ye Yang, Haifeng Ji, Chao He, Chong Cheng, Changsheng Zhao
Pathogenic bacterial infection has been becoming as a global threat towards people's health, especially the massive usage of antibiotics due to the lack of antibacterial agents with less side-effects. Developing new nano-agents to fight pathogenic bacteria has provided enormous new possibilities in the treatment of bacterial infections, such as the graphene based 2D antibacterial nano-agents with different bacterial inhibition capabilities; however, mussel-inspired design of NIR-responsive and biocompatible Ag-graphene nano-agents possessed with efficient and versatile bacterial disinfection activities have rarely been reported...
December 13, 2017: 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
#3
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
#4
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
#5
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)
https://www.readbyqxmd.com/read/29030527/holistic-considerations-in-optimizing-a-sterile-product-package-to-ensure-container-closure-integrity
#6
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
https://www.readbyqxmd.com/read/29026662/intrathecal-and-intraventricular-antibiotics-for-postoperative-gram-negative-meningitis-and-ventriculitis
#7
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
https://www.readbyqxmd.com/read/28974812/effect-of-nisin-on-biogenic-amines-and-shelf-life-of-vacuum-packaged-rainbow-trout-oncorhynchus-mykiss-fillets
#8
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
https://www.readbyqxmd.com/read/28967607/reduction-and-standardization-of-surgical-instruments-in-pediatric-inguinal-hernia-repair
#9
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
https://www.readbyqxmd.com/read/28928291/inhibiting-sterilization-induced-oxidation-of-large-molecule-therapeutics-packaged-in-plastic-parenteral-vials
#10
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
https://www.readbyqxmd.com/read/28928290/enhancing-patient-safety-through-the-use-of-a-pharmaceutical-glass-designed-to-prevent-cracked-containers
#11
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...
September 19, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28926878/-effects-of-arnebia-root-oil-on-wound-healing-of-rats-with-full-thickness-skin-defect-and-the-related-mechanism
#12
J Y Shen, Q Ma, Z B Yang, J J Gong, Y S Wu
Objective: To observe the effects of arnebia root oil on wound healing of rats with full-thickness skin defect, and to explore the related mechanism. Methods: Eighty SD rats were divided into arnebia root oil group and control group according to the random number table, with 40 rats in each group, then full-thickness skin wounds with area of 3 cm×3 cm were inflicted on the back of each rat. Wounds of rats in arnebia root oil group and control group were treated with sterile medical gauze and bandage package infiltrated with arnebia root oil gauze or Vaseline gauze, respectively, with dressing change of once every two days...
September 20, 2017: Zhonghua Shao Shang za Zhi, Zhonghua Shaoshang Zazhi, Chinese Journal of Burns
https://www.readbyqxmd.com/read/28898722/influence-of-gamma-and-electron-beam-sterilization-on-the-stability-of-a-premixed-injectable-calcium-phosphate-cement-for-trauma-indications
#13
Kieran A Murray, Maurice N Collins, Regina P O'Sullivan, Guang Ren, Declan M Devine, Alan Murphy, Jarosław Sadło, Carol O'Sullivan, Brian McEvoy, Olivier Vrain, Cathriona O'Neill, Gerard Insley
Premixed calcium phosphate cements (CPC's) are becoming the material of choice for injectable cements as a result of their effective delivery to the target implantation site. For orthopaedic use, it is of vital importance that the attributes of these CPC's are not compromised by irradiation sterilization. Therefore, the aim of this study is to determine the influence of irradiation sterilization on a range of premixed CPC's, with an emphasis on improving product shelf life through the use of optimal packaging configurations and annealing steps...
September 5, 2017: Journal of the Mechanical Behavior of Biomedical Materials
https://www.readbyqxmd.com/read/28894161/microbial-communities-in-placentas-from-term-normal-pregnancy-exhibit-spatially-variable-profiles
#14
Lindsay A Parnell, Catherine M Briggs, Bin Cao, Omar Delannoy-Bruno, Andrew E Schrieffer, Indira U Mysorekar
The placenta is the principal organ nurturing the fetus during pregnancy and was traditionally considered to be sterile. Recent work has suggested that the placenta harbours microbial communities, however the location and possible function of these microbes remain to be confirmed and elucidated. Here, we employed genomic DNA sequencing of multiple variable (V) regions of the bacterial 16S ribosomal gene, to interrogate microbial profiles in term pregnancies, from the basal plate, which is in direct contact with maternal uterine, endothelial, and immune cells; placental villi, which are bathed in maternal blood, and fetal membranes, which encapsulate the amniotic cavity...
September 11, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28893036/oral-candidal-carriage-in-subjects-with-pure-vegetarian-and-mixed-dietary-habits
#15
Shankargouda Patil, Roopa S Rao, A Thirumal Raj, D S Sanketh, Sachin Sarode, Gargi Sarode
INTRODUCTION: Candida albicans being a part of the normal oral microbial flora is one of the most commonly isolated species from the oral cavity. Recent studies have shown a steady rise in the number of non C. albicans species, which are relatively resistant to common antifungal agents and are being recognized as potential pathogens. It is vital to ascertain the predisposing factors leading to such a shift in the oral candidal flora. AIM: To estimate the prevalence of candidal species among vegetarians and non-vegetarians...
July 2017: Journal of Clinical and Diagnostic Research: JCDR
https://www.readbyqxmd.com/read/28858636/damage-associated-molecular-pattern-markers-hmgb1-and-cell-free-fetal-telomere-fragments-in-oxidative-stressed-amnion-epithelial-cell-derived-exosomes
#16
Samantha Sheller-Miller, Rheanna Urrabaz-Garza, George Saade, Ramkumar Menon
Term labor in humans is associated with increased oxidative stress (OS) -induced senescence and damages to amnion epithelial cells (AECs). Senescent fetal cells release alarmin high-mobility group box 1 (HMGB1) and cell-free fetal telomere fragments (cffTF) which can be carried by exosomes to other uterine tissues to produce parturition-associated inflammatory changes. This study characterized AEC-derived exosomes under normal and OS conditions and their packaging of HMGB1 and cffTF. Primary AECs were treated with either standard media or oxidative stress-induced media (exposure to cigarette smoke extract for 48h)...
September 2017: Journal of Reproductive Immunology
https://www.readbyqxmd.com/read/28819049/a-comparison-of-protein-stability-in-prefillable-syringes-made-of-glass-and-plastic
#17
Lloyd Waxman, Vinod D Vilivalam
The development of protein therapeutics requires stabilization of these labile molecules during shipment and storage. Biologics, particularly monoclonal antibodies, are frequently packaged at high concentration in prefillable syringes traditionally made of glass. However, some biologics are unstable in glass due to sensitivity to silicone oil, tungsten, glue or metal ions. Syringes made from the plastic cyclic olefin polymer, Daikyo Crystal Zenith® (CZ), with a Flurotec-laminated piston have none of these issues...
August 17, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28799106/chemical-sterilization-of-allograft-dermal-tissues
#18
Abigail Phipps, Edward Vaynshteyn, John B Kowalski, Manh-Dan Ngo, Karen Merritt, Joel Osborne, Evangelia Chnari
Common terminal sterilization methods are known to alter the natural structure and properties of soft tissues. One approach to providing safe grafts with preserved biological properties is the combination of a validated chemical sterilization process followed by an aseptic packaging process. This combination of processes is an accepted method for production of sterile healthcare products as described in ANSI/AAMI ST67:2011. This article describes the validation of the peracetic acid and ethanol-based (PAAE) chemical sterilization process for allograft dermal tissues at the Musculoskeletal Transplant Foundation (MTF, Edison, NJ)...
December 2017: Cell and Tissue Banking
https://www.readbyqxmd.com/read/28757084/outbreak-of-health-care-associated-burkholderia-cenocepacia-bacteremia-and-infection-attributed-to-contaminated-sterile-gel-used-for-central-line-insertion-under-ultrasound-guidance-and-other-procedures
#19
Ramon Z Shaban, Samuel Maloney, John Gerrard, Peter Collignon, Deborough Macbeth, Marilyn Cruickshank, Anna Hume, Amy V Jennison, Rikki M A Graham, Haakon Bergh, Heather L Wilson, Petra Derrington
BACKGROUND: We report an outbreak of Burkholderia cenocepacia bacteremia and infection in 11 patients predominately in intensive care units caused by contaminated ultrasound gel used in central line insertion and sterile procedures within 4 hospitals across Australia. METHODS: Burkholderia cenocepacia was first identified in the blood culture of a patient from the intensive care unit at the Gold Coast University Hospital on March 26, 2017, with 3 subsequent cases identified by April 7, 2017...
July 27, 2017: American Journal of Infection Control
https://www.readbyqxmd.com/read/28687186/evaluation-of-a-new-packaging-process-for-non-autoclavable-endoscopes-results-for-the-first%C3%A2-100%C3%A2-microbiological-samples
#20
C Minebois, P Saviuc, J Shum, P Tuvignon, I Pelloux, M-P Brenier-Pinchart, C Landelle, M-R Mallaret
BACKGROUND: A new process for packaging endoscopes (SureStore®, Medical Innovations Group) immediately after they exit from washing and disinfection in an automated endoscope reprocessor (AER) allows for endoscopes to be stored for up to 15 days. AIM: To describe the microbiological quality of samples from gastrointestinal endoscopes following this process. METHODS: Three-month prospective study using microbiological sampling from a stock of 38 gastrointestinal endoscopes carried out in a French University Hospital...
December 2017: Journal of Hospital Infection
keyword
keyword
85036
1
2
Fetch more papers »
Fetching more papers... Fetching...
Read by QxMD. Sign in or create an account to discover new knowledge that matter to you.
Remove bar
Read by QxMD icon Read
×

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"