scholarly journals Physicochemical stability of pembrolizumab admixture solution in normal saline intravenous infusion bag

2019 ◽  
Vol 26 (3) ◽  
pp. 641-646 ◽  
Author(s):  
Prakash Sundaramurthi ◽  
Sean Chadwick ◽  
Chakravarthy Narasimhan
Keyword(s):  
Normal Saline ◽  
Intravenous Infusion ◽  
Room Temperature ◽  
Extended Period ◽  
End User ◽  
Physicochemical Stability ◽  
Diluted Solution ◽  
Aseptic Conditions ◽  
Physical Instability

Introduction Pembrolizumab is an anti-PD-1 monoclonal antibody, approved and under development for numerous indications in oncology. It is available as either lyophilized powder for reconstitution or ready-to-use solution. Both are required to be diluted in saline or dextrose solution prior to intravenous infusion. After dilution, the recommendation per summary of product characteristics is 24 h at 2–8℃ and 6 h at room temperature. The purpose of this study was to investigate the physicochemical stability of pembrolizumab diluted solution (1 mg/mL) at both refrigerated and room temperature conditions for an extended period. Methods Under aseptic conditions, pembrolizumab was diluted in 250 mL of saline injection in polyolefin bags to obtain the final protein concentration of 1 mg/mL. Thus, prepared bags were then stored at either 5℃ ± 3℃, refrigerator exposing the product to ambient light or room temperature (20℃ ± 3℃) on the benchtop. Results Using several analytical methods, it was demonstrated that pembrolizumab solution for infusion, diluted in normal saline can be stored in polyolefin infusion bags for at least 1 week at 5℃ or RT with no evidence of chemical or physical instability. No aggregation was observed. Conclusion Thus, the practical use of aseptically prepared diluted pembrolizumab in saline can be safely extended to optimize the workload of centralized preparation units and to minimize costs. However, it is the responsibility of the end-user to maintain overall quality of prepared admixture solution that is administered to patient, by following aseptic compounding process as recommended in the packaging insert.

Stability of Five Antibiotics

1980 ◽  
Vol 14 (12) ◽  
pp. 848-850 ◽  
Author(s):  
Elizabeth Chow Tung ◽  
Ernest L. Gurwich ◽  
Joseph A. Sula ◽  
Michael Kodack
Keyword(s):  
Sodium Chloride ◽  
Sodium Bicarbonate ◽  
Normal Saline ◽  
Room Temperature ◽  
Agar Gel ◽  
Diffusion Technique ◽  
The Stability ◽  
Aseptic Conditions ◽  
Erythromycin Lactobionate ◽  
Gel Diffusion

The stability of methicillin, amikacin, erythromycin lactobionate, vancomycin, and ticarcillin in plastic intravenous containers of sodium chloride injection 0.9%, USP and dextrose 5% injection, USP was studied. The study was conducted under aseptic conditions for a period of 24 hours. The samples, drawn at various times, were assayed by a modified agar gel diffusion technique. The study solutions were stored at room temperature. This study revealed that amikacin, methicillin, vancomycin, and ticarcillin are stable for 24 hours in the test solutions. Erythromycin lactobionate is stable for 24 hours in normal saline, but the addition of sodium bicarbonate 4% (Neut®) was necessary to assure stability in dextrose 5 %.

Technology characteristics predicting end user acceptance of smart intravenous infusion pumps

2005 ◽  
Author(s):  
Tosha B. Wetterneck ◽  
Pascale Carayon ◽  
Folasade Sobande ◽  
Ann Schoofs Hundt
Keyword(s):  
Intravenous Infusion ◽  
User Acceptance ◽  
End User ◽  
Infusion Pumps

THE STUDY ON TA VAT WINE PRODUCTION FROM SUGAR PALM (ARENGA PINNATA) SAP

2014 ◽  
Vol 83 (5) ◽  
Author(s):  
Nguyễn Thị Hồng Thu ◽  
Đặng Minh Nhật ◽  
Nguyễn Hoàng Dung
Keyword(s):  
Room Temperature ◽  
Fermentation Process ◽  
Inoculum Size ◽  
Wine Fermentation ◽  
Wine Production ◽  
Factors Affecting ◽  
Natural Fermentation ◽  
Tropical Asia ◽  
Best Parameters

Sugar palm (Arenga pinnata) is a feather palm native to tropical Asia. In Vietnam, it is named Búng Báng or Đoác and grown only on the highlands in the central or northern part of Vietnam. It is utilized for many purposes, especially for Ta Vat wine production - a characteristic and unique product of Co Tu ethnic minority. However, because of the natural fermentation used in the production, the product quality is inconsistent. The purpose of this study was to examine a new procedure of using palm sap for making Ta Vat wine. Some characteristics of the sap, which was collected at Nam Giang district, Quang Nam province are determined, proving the potential of the sap for making wine product. The quality of sap changes quickly at room temperature. At low temperature (4 - 60C), the changes in sap quality are apparently slower. Examining some factors affecting its quality during the wine fermentation process, we determined the best parameters for the fermentation process as follows: inoculum size of 3% with cell density of about 1x108 cells/ml, the addition of the extract from the bark of Ceylon ironwood (Mesua ferrea L.) 4%. Keywords: Arenga pinnata, sap, Ceylon ironwood bark, Mesua ferrea L., wine fermentation.

scholarly journals Long-Term Cryopreservation Does Not Affect Quality of Peripheral Blood Stem Cell Grafts: A Comparative Study of Native, Short-Term and Long-Term Cryopreserved Haematopoietic Stem Cells

2021 ◽  
Vol 30 ◽  
pp. 096368972110360
Author(s):  
Daniel Lysak ◽  
Michaela Brychtová ◽  
Martin Leba ◽  
Miroslava Čedíková ◽  
Daniel Georgiev ◽  
...  
Keyword(s):  
Stem Cells ◽  
Stem Cell ◽  
Statistical Significance ◽  
Extended Period ◽  
High Dose ◽  
Atp Production ◽  
Cd34 Cells ◽  
Negative Effect

Cryopreserved haematopoietic progenitor cells are used to restore autologous haematopoiesis after high dose chemotherapy. Although the cells are routinely stored for a long period, concerns remain about the maximum storage time and the possible negative effect of storage on their potency. We evaluated the effect of cryopreservation on the quality of peripheral stem cell grafts stored for a short (3 months) and a long (10 years) period and we compared it to native products.The viability of CD34+ cells remained unaffected during storage, the apoptotic cells were represented up to 10% and did not differ between groups. The clonogenic activity measured by ATP production has decreased with the length of storage (ATP/cell 1.28 nM in native vs. 0.63 in long term stored products, P < 0.05). Only borderline changes without statistical significance were detected when examining mitochondrial and aldehyde dehydrogenase metabolic activity and intracellular pH, showing their good preservation during cell storage. Our experience demonstrates that cryostorage has no major negative effect on stem cell quality and potency, and therefore autologous stem cells can be stored safely for an extended period of at least 10 years. On the other hand, long term storage for 10 years and longer may lead to mild reduction of clonogenic capacity. When a sufficient dose of stem cells is infused, these changes will not have a clinical impact. However, in products stored beyond 10 years, especially when a low number of CD34+ cells is available, the quality of stem cell graft should be verified before infusion using the appropriate potency assays.

scholarly journals Challenges and Perspectives on Breast Cancer Survivorship: The Journey Continues

2020 ◽  
Vol 4 (Supplement_1) ◽  
pp. 96-96
Author(s):  
Victoria Raveis ◽  
Simona Kwon
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Cancer Survivor ◽  
Breast Cancer Survivors ◽  
Cancer Survival ◽  
Survival Rates ◽  
Extended Period ◽  
Health Issues ◽  
Age Related

Abstract Women have a 1-in-8 lifetime risk of breast cancer. Earlier diagnosis and treatment advances have improved 15- and 20-year survival rates. Increased survival can mean coping with the effects of cancer and its treatment over an extended period of time, while experiencing age-related changes in functioning and the emergence of other health issues. To explore breast cancer survivors’ perspectives on their issues and concerns across the life-course, focus groups were conducted with a culturally diverse sample (N=18) of survivors (72% white, 28% Black, 11% Hispanic). Participants were 44-82 years old. Most, 83% were 50 and older, 56% were 60 and older. The majority (83%) were diagnosed in their 40’s and 50’s. Two were diagnosed in their early 30’s and one at age 68. Participants reaffirmed the necessity, as a breast cancer survivor, of being a life-long health advocate on their own behalf, and the importance of being self-informed. As one woman commented: “Knowledge is power”. Survivors shared that their emergent health issues were complicated by their cancer history, and, that, as a cancer survivor, “I never stop worrying”. A widespread concern was not knowing if the health issues and co-morbidities they experienced (such as joint pain, neuropathy, tendinitis, heart disease), were age-related, a consequence of their cancer, or a late treatment effect. An overriding sentiment expressed was that clinicians have not recognized the importance of quality of life in cancer survival. As a survivor succinctly stated: “We are living longer, but we need to live long with quality of life.”

scholarly journals Identification of the State of Electrical Appliances with the Use of a Pulse Signal Generator

Energies ◽  
2021 ◽  
Vol 14 (3) ◽  
pp. 673
Author(s):  
Augustyn Wójcik ◽  
Piotr Bilski ◽  
Robert Łukaszewski ◽  
Krzysztof Dowalla ◽  
Ryszard Kowalik
Keyword(s):  
Measurement System ◽  
Cross Correlation ◽  
Pulse Signal ◽  
Signal Generator ◽  
Experimental Results ◽  
The Novel ◽  
End User ◽  
Standard Classification ◽  
Electrical Appliance

The paper presents the novel HF-GEN method for determining the characteristics of Electrical Appliance (EA) operating in the end-user environment. The method includes a measurement system that uses a pulse signal generator to improve the quality of EA identification. Its structure and the principles of operation are presented. A method for determining the characteristics of the current signals’ transients using the cross-correlation is described. Its result is the appliance signature with a set of features characterizing its state of operation. The quality of the obtained signature is evaluated in the standard classification task with the aim of identifying the particular appliance’s state based on the analysis of features by three independent algorithms. Experimental results for 15 EAs categories show the usefulness of the proposed approach.

scholarly journals In vitro characteristics and in vivo platelet quality of whole blood treated with riboflavin and UVA / UVB light and stored for 24 hours at room temperature

Transfusion ◽  
2021 ◽  
Vol 61 (S1) ◽  
Author(s):  
Turid Helen Felli Lunde ◽  
Lindsay Hartson ◽  
Shawn Lawrence Bailey ◽  
Tor Audun Hervig
Keyword(s):  
Whole Blood ◽  
Room Temperature

Proteinase and phospholipase activities and development at different temperatures of yeasts isolated from bovine milk

2011 ◽  
Vol 78 (4) ◽  
pp. 385-390 ◽  
Author(s):  
Priscilla A Melville ◽  
Nilson R Benites ◽  
Monica Ruz-Peres ◽  
Eugenio Yokoya
Keyword(s):  
Dairy Products ◽  
Room Temperature ◽  
Bovine Milk ◽  
Raw Milk ◽  
Pathogenic Potential ◽  
Proteinase Production ◽  
Different Temperatures ◽  
Quality Of Milk ◽  
Means Of Transmission

The presence of yeasts in milk may cause physical and chemical changes limiting the durability and compromising the quality of the product. Moreover, milk and dairy products contaminated by yeasts may be a potential means of transmission of these microorganisms to man and animals causing several kinds of infections. This study aimed to determine whether different species of yeasts isolated from bovine raw milk had the ability to develop at 37°C and/or under refrigeration temperature. Proteinase and phospholipase activities resulting from these yeasts were also monitored at different temperatures. Five genera of yeasts (Aureobasidium sp., Candida spp., Geotrichum spp., Trichosporon spp. and Rhodotorula spp.) isolated from bovine raw milk samples were evaluated. All strains showed one or a combination of characteristics: growth at 37°C (99·09% of the strains), psychrotrophic behaviour (50·9%), proteinase production (16·81% of the strains at 37°C and 4·09% under refrigeration) and phospholipase production (36·36% of the isolates at 37°C and 10·9% under refrigeration), and all these factors may compromise the quality of the product. Proteinase production was similar for strains incubated at 37°C (16·81% of the isolates) and room temperature (17·27%) but there was less amount of phospholipase-producing strains at room temperature (15·45% of the isolates were positive) when compared with incubation at 37°C (36·36%). Enzymes production at 37°C by yeasts isolated from milk confirmed their pathogenic potential. The refrigeration temperature was found to be most efficient to inhibit enzymes production and consequently ensure better quality of milk. The viability of yeasts and the activity of their enzymes at different temperatures are worrying because this can compromise the quality of dairy products at all stages of production and/or storage, and represent a risk to the consumer.

The prediction of the cyclic mechanical behavior of stainless steel 304L at room temperature

2021 ◽  
Vol ahead-of-print (ahead-of-print) ◽  
Author(s):  
Hala Messai ◽  
Salim Meziani ◽  
Athmane Fouathia
Keyword(s):  
Stainless Steel ◽  
Design Methodology ◽  
Room Temperature ◽  
Type Model ◽  
Good Prediction ◽  
304L Stainless Steel ◽  
Content Type ◽  
The Third ◽  
Chaboche Model

Purpose The purpose of this paper is to highlight the performance of the Chaboche model in relation to the database identification, tests with imposed deformations were conducted at room temperature on 304L stainless steel specimens. Design/methodology/approach The first two tests were performed in tension-compression between ±0.005 and ±0.01; in the third test, each cycle is composed of the combination of a compression tensile cycle between ±0.01 followed by a torsion cycle between ±0.01723 (non-proportional path), and the last, uniaxial ratcheting test with a mean stress between 250 MPa and −150 MPa. Several identifications of a Chaboche-type model were then performed by considering databases composed of one or more of the cited tests. On the basis of these identifications, the simulations of a large number of ratchet tests in particular were carried out. Findings The results present the effect of the optimized parameters on the prediction of the behavior of materials which is reported in the graphs, Optimizations 1 and 2 of first and second tests and Optimization 4 of the third test giving a good prediction of the increasing/decreasing pre-deformation amplitude. Originality/value The quality of the model's predictions strongly depends on the richness of the database used for the identification of the parameters.

DEVELOPMENT OF CITRUS BASED BEVERAGE UTILIZING BACOPA MONNIERI

2021 ◽  
pp. 18-19
Author(s):  
Twamoghna De ◽  
Purushottam Kumar ◽  
Jayati Pal
Keyword(s):  
Sensory Evaluation ◽  
Room Temperature ◽  
Control Sample ◽  
Leaf Extracts ◽  
Nutritional Values ◽  
Soda Water ◽  
Three Samples ◽  
Microbial Analysis ◽  
And Storage

The study was done to formulate a drink from an old medicinal herb and retain all the potential benets with a new taste and avor. For this an herbal drink was formulated and its quality ascertained. In the rst part of the study, syrup was prepared from the raw leaves of the herb with addition of acids and avors. Then this syrup was diluted further followed by carbonation with 1:3 ratio of soda water and bottled. Three samples were prepared namely, T1 (same as previous but with 1:3 ratio carbonation and dividing the sample hot lled and cold lled ). In the next part, prepared samples were subjected to sensory evaluation,chemical and microbial analysis when fresh and 0 after regular intervals at room temperature (27±1 °C) and refrigerated temperature (below 7 C). Microbial analysis of the product was done to check the quality of the herbal drink and self-life of the product. The control sample T1 cold lled was the most acceptable due to its unique taste and avor, followed by sample T1( hot lled) . The present study entailed to conclude that preparation of a drink with B. monnieri leaf extracts gives a new taste and avor with high nutritional values. This drink can be stored safe for nearly a month if carbonated and storage at refrigerated 0 temperature (below 5 C).

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