Bevacizumab Sterility in Multiple Doses from a Single-Use Vial

2008 ◽  
Vol 42 (10) ◽  
pp. 1425-1428 ◽  
Author(s):  
Kemal Örnek ◽  
Zeynep Ceren Karahan ◽  
Ahmet Ergin ◽  
Alper Tekeli ◽  
Oya Tekeli

Background: Recent reports have demonstrated that refrigerated bevacizumab can be stored for up to 3 weeks at 4 °C without loss of efficacy. There have been no previous reports addressing bevacizumab's sterility when stored and used as multiple doses from a single-use vial. Objective: To evaluate the sterility of bevacizumab when used as multiple doses from a single-use vial. Methods: Four groups of vials were used to simulate the storage and use conditions for bevacizumab. Each group contained 11 doses of 0.2 mL of bevacizumab. One sample from each group was cultured once each day at 37 °C for 10 days; one sample from each group was left for 15 days. MacConkey agar, blood agar, thioglycollate broth, and Sabouraud medium were used to assess bacterial and fungal growth. Results: A total of 44 samples of bevacizumab were included in this study. Each sample was placed on 4 growth media for microbial readings. All samples were found to be negative for microbial growth. No significant differences were observed among the groups. Possible limitations of this study included the number of samples for each group and in vitro design of the study, which might have affected the growth of bacterial organisms. Conclusions: Storage and multiple use of bevacizumab from single-use vials does not seem to result in microbial contamination.

2021 ◽  
Vol 16 (2) ◽  
pp. 001-013
Author(s):  
Abwe Mercy Ngone ◽  
Lawrence Monah Ndam ◽  
Rita Mungfu Njilar ◽  
Doungous Oumar ◽  
Thomas Eku Njock

Plant tissue culture requires the optimization of growth media. Gnetum, known locally in Cameroon as “Eru” is an indigenous gymnospermous vegetable with diverse medicinal, nutritional, cultural and socio-economic values. This resource is over-exploited and expected to neighboring countries, resulting to increased scarcity in the forest. Preliminary work on the in vitro culture of nodal cuttings was faced by the problem of fungal contamination. It was therefore necessary to isolate and identify the fungal contaminant, optimize the surface sterilization of field material and compose an appropriate medium for sprouting. Pure cultures of the fungus were obtained and grown on Potato Dextrose Agar (PDA) and Sabouraud Dextrose Agar (SDA). The identification was based on the appearance of the fungal growth on plates and also on the microscopic view. This was affected by the use of keys. Gnetum explants were disinfected with the various concentrations of disinfectants, preceded in some instances by pre-treatments, as well as incorporating fungicides in the culture medium. Two different culture media were employed: the Woody Plant Medium (WPM) and the Murashige and Skoog (MS) based establishment medium (Y-1). Gnetum was found to live in association with a complex of Microsporum species. The level of contamination of cultures was reduced from 100% to 40% when pre-treated before disinfection and even lower to 10% by incorporating fungicides in the medium. Sprouting was observed in WPM. This study provides baseline information on the in vitro propagation of Gnetum and thus opens up avenues for more research to be carried out in this field.


2018 ◽  
Vol 23 (4) ◽  
pp. 311-314 ◽  
Author(s):  
Vi Ean Tan ◽  
Alan T. Evangelista ◽  
Dominick M. Carella ◽  
Daniel Marino ◽  
Wayne S. Moore ◽  
...  

OBJECTIVES There is a lack of standardization and supporting data regarding the duration preassembled and preprimed extracorporeal membrane oxygenation (ECMO) circuits are expected to be sterile. Therefore, the purpose of this study was to prospectively evaluate whether preassembled and preprimed ECMO circuits could maintain sterility for a period up to 65 days. DESIGN Four ECMO circuits (2 neonatal/pediatric¼” and 2 adolescent/adult ⅜ ”) were assembled and primed under sterile conditions and maintained at room temperature. Culture samples were obtained from each circuit and plated within 1 hour. Culture samples were obtained on day 0 when assembled and primed then every 5 days up to day 65. Samples were plated on several different media including the following: blood agar plate: trypticase soy agar with 5% sheep blood, MacConkey agar, and thioglycollate broth then incubated at 35°C for 3 days. RESULTS All cultures obtained from the priming solution from of the¼” and ⅜ ” ECMO circuits produced no microbial or fungal growth for the 65-day study period. CONCLUSION These pilot data suggest preprimed ECMO circuits may maintain sterility for a period up to 65 days. Additional studies evaluating a larger number of ECMO circuits are needed to confirm these findings.


2020 ◽  
Vol 2020 ◽  
pp. 1-10 ◽  
Author(s):  
Lydia G. Mugao ◽  
Phyllis W. Muturi ◽  
Bernard M. Gichimu ◽  
Ezekiel K. Njoroge

Tomato production is constrained by fungal diseases especially the early and late blight caused by Alternaria solani and Phytophthora infestans, respectively. Control of the two diseases is usually by use of synthetic fungicides which have a long residue effect and also contribute to environmental pollution. Innovative use of biocontrols may offer an eco-friendly and more sustainable solution. This study tested the in vitro efficacy of crude extracts and essential oils of ginger, garlic, tick berry, and Mexican marigold in inhibition of radial growth of A. solani and P. infestans. Extraction of the crude extracts was done using distilled water, ethanol, and methanol solvents, while essential oils were extracted using the dry steam distillation method. The extracts and essential oils were used to amend the growth media of the test pathogens before introducing the precultured pathogens. Sterile distilled water and synthetic fungicide, Ridomil Gold®, were used as positive and negative controls, respectively. Fungal growth inhibition was determined by measuring the radial growth of the test pathogens. Both the crude extracts and the essential oils portrayed some efficacy against the test pathogens. Garlic crude extracts were found to be the most effective, while ethanol was the most suitable extraction solvent. Essential oils were more effective in restricting the pathogen growth than crude extracts. Ginger and garlic oil was found to be as effective as the synthetic fungicide, and thus it was concluded that the two plants have strong antifungal properties with high potential of being utilized as biofungicides. However, effective utilization of these products in farmers’ fields may require industrial formulation to improve their efficiency.


2005 ◽  
Vol 2 (3) ◽  
pp. 277-293 ◽  
Author(s):  
K. Kolo ◽  
Ph. Claeys

Abstract. This study investigates the in vitro formation of Ca-oxalates and glushinskite through fungal interaction with carbonate substrates and seawater as a process of biologically induced metal recycling and neo-mineral formation. The study also emphasizes the role of the substrates as metal donors. In the first experiment, thin sections prepared from dolomitic rock samples of Terwagne Formation (Carboniferous, Viséan, northern France) served as substrates. The thin sections placed in Petri dishes were exposed to fungi grown from naturally existing airborne spores. In the second experiment, fungal growth and mineral formation was monitored using only standard seawater (SSW) as a substrate. Fungal growth media consisted of a high protein/carbohydrates and sugar diet with demineralized water for irrigation. Fungal growth process reached completion under uncontrolled laboratory conditions. The newly formed minerals and textural changes caused by fungal attack on the carbonate substrates were investigated using light and scanning electron microscopy (SEM-EDX), x-ray diffraction (XRD) and Raman spectroscopy. The fungal interaction and attack on the dolomitic and seawater substrates resulted in the formation of Ca-oxalates (weddellite CaC2O4·2(H2O), whewellite (CaC2O4·(H2O)) and glushinskite MgC2O4·2(H2O) associated with the destruction of the original hard substrates and their replacement by the new minerals. Both of Ca and Mg were mobilized from the experimental substrates by fungi. This metal mobilization involved a recycling of substrate metals into newly formed minerals. The biochemical and diagenetic results of the interaction strongly marked the attacked substrates with a biological fingerprint. Such fingerprints are biomarkers of primitive life. The formation of glushinskite is of specific importance that is related, besides its importance as a biomineral bearing a recycled Mg, to the possibility of its transformation through diagenetic pathway into an Mg carbonate. This work is the first report on the in vitro formation of the mineral glushinskite through fungal interaction with carbonate and seawater substrates. Besides recording the detailed Raman signature of various crystal habits of Mg- and Ca-oxalates, the Raman spectroscopy proved two new crystal habits for glushinskite. The results of this work document the role of microorganisms as metal recyclers in biomineralization, neo-mineral formation, sediment diagenesis, bioweathering and in the production of mineral and diagenetic biomarkers. They also reveal the capacity of living fungi to interact with liquid substrates and precipitate new minerals.


2015 ◽  
Vol 3 (3) ◽  
pp. 374-379 ◽  
Author(s):  
Neveen Helmy Abou El-Soud ◽  
Mohamed Deabes ◽  
Lamia Abou El-Kassem ◽  
Mona Khalil

BACKGROUND: The leaves of Ocimum basilicum L. (basil) are used in traditional cuisine as spices; its essential oil has found a wide application in perfumery, dental products as well as antifungal agents.AIM: To assess the chemical composition as well as the in vitro antifungal activity of O. basilicum L. essential oil against Aspergillus flavus fungal growth and aflatoxin B1 production.MATERIAL AND METHODS: The essential oil of O. basilicum was obtained by hydrodistillation and analysed using gas chromatography (GC) and GC coupled with mass spectrometry (GC/MS). The essential oil was tested for its effects on Aspergillus flavus (A. flavus) mycelial growth and aflatoxin B1 production in Yeast Extract Sucrose (YES) growth media. Aflatoxin B1 production was determined by high performance liquid chromatography (HPLC).RESULTS: Nineteen compounds, representing 96.7% of the total oil were identified. The main components were as follows: linalool (48.4%), 1,8-cineol (12.2%), eugenol (6.6%), methyl cinnamate (6.2%), α-cubebene (5.7%), caryophyllene (2.5%), β-ocimene (2.1%) and α-farnesene (2.0%).The tested oil showed significant antifungal activity that was dependent on the used oil concentration. The complete inhibition of A. flavus growth was observed at 1000 ppm oil concentration, while marked inhibition of aflatoxin B1 production was observed at all oil concentrations tested (500, 750 and 1000 ppm).CONCLUSION: These results confirm the antifungal activities of O. basilicum L. oil and its potential use to cure mycotic infections and act as pharmaceutical preservative against A. flavus growth and aflatoxin B1 production.


Author(s):  
Tim Eaton ◽  
L Ramscar ◽  
J Cox ◽  
WILLIAM Whyte

The likelihood of the transfer of microbial contamination from the surface of a vial septum into the vial liquid, by penetration of a hypodermic syringe needle, has been investigated. Experimental work was carried out with vials containing sterile microbial growth media and the use of needles of three different diameters. Three different concentrations of microbes on the surface of the vial septum (10, 100, and 1000) were used. Microbial contamination that was transferred into the growth media was determined by incubation of the vials following penetration of the septum by the needles. Contamination was detected in 87% of all the vials tested, and was generally found to increase as the concentration of septum challenge organisms and needle diameter increased. Key words: Septum seals, hypodermic needles, multi-use vials, microbial contamination


2019 ◽  
Author(s):  
James B. Y. H. Behrendorff ◽  
Guillem Borràs-Gas ◽  
Mathias Pribil

AbstractBackgroundStable genetic transformation of plants is a low-efficiency process, and identification of positive transformants usually relies on screening for expression of a co-transformed marker gene. Often this involves germinating seeds on solid media containing a selection reagent. Germination on solid media requires surface sterilization of seeds and careful aseptic technique to prevent microbial contamination, but surface sterilization techniques are time consuming and can cause seed mortality if not performed carefully. We developed an antimicrobial cocktail that can be added to solid media to inhibit bacterial and fungal growth without impairing germination, allowing us to bypass the surface sterilization step.ResultsAdding a combination of terbinafine (1 µM) and timentin (200 mg/L) to solid media delayed the onset of observable microbial growth and did not affect germination of non-sterile seeds from ten different wild-type and mutant Arabidopsis thaliana accessions. The method was also compatible with Nicotiana tabacum germination. Seedlings sown in non-sterile conditions could be maintained on antimicrobial media for up to a week without observable contamination. The antimicrobial cocktail was compatible with rapid screening methods for hygromycin B, phosphinothricin (BASTA) and nourseothricin resistance genes, meaning that positive transformants can be identified from non-sterile seeds in as little as four days after stratification and transferred to soil before the onset of visible microbial contamination.ConclusionThe antimicrobial cocktail presented here delays microbial growth for long enough to permit germination of non-sterile Arabidopsis thaliana seedlings on solid media and it is compatible with rapid screening methods. We were able to select genetic transformants on solid media without seed surface sterilization, eliminating a tedious and time-consuming step.


2005 ◽  
Vol 2 (2) ◽  
pp. 451-497 ◽  
Author(s):  
K. Kolo ◽  
Ph. Claeys

Abstract. This study investigates the in vitro formation of Ca-oxalates and glushinskite through fungal interaction with carbonate substrates and seawater. In the first experiment, thin-sections prepared from dolomitic rock samples of Terwagne Formation (Carboniferous, Viséan, northern France) served as substrates. The thin sections placed in Petri dishes were exposed to fungi grown from naturally existing airborne spores. In the second experiment, fungal growth and mineral formation was monitored using only standard seawater (SSW) as substrate. Fungal growth media consisted of a high protein/carbohydrates and sugar diet with demineralised water for irrigation. Fungal growth process reached completion under uncontrolled laboratory conditions. The fungal interaction and attack on the carbonate substrates resulted in the formation of Ca-oxalates (weddellite CaC2O4·2(H2O), whewellite (CaC2O4·(H2O)) and glushinskite MgC2O4·2(H2O) associated with the destruction of the original substrate and its replacement by the new minerals. The seawater substrate resulted also in the formation of glushinskite and Ca-oxalates. Both of Ca and Mg were mobilized from the experimental substrates by fungi. The newly formed minerals and textural changes caused by fungal attack on the carbonate substrate were investigated using light and scanning electron microscopy (SEM-EDX), x-ray diffraction (XRD) and Raman spectroscopy. The results document the role of microorganisms in biomineralization, neo-mineral formation and sediment diagenesis. They also reveal the capacity of living fungi to interact with liquid substrates and precipitate new minerals. This work is the first report on the in vitro formation of the mineral glushinskite through fungal-carbonate and sea water substrates interactions processes.


2021 ◽  
Vol 12 (3) ◽  
pp. 513-517
Author(s):  
Rakshitha D ◽  
Neha Semwal ◽  
Gazala Hussain

Introduction: Primary dosage forms are basic preparations whose shelf life is a challenge for the practice. Kwatha is a preparation which is easily prone to contamination and can be marketed only by the addition of suitable preservatives to increase the shelf life. So addition of preservatives is being practiced to prolong the shelf life of kwatha but presently using chemical preservatives are harmful to body and even have carcinogenic effects. Hence there aroused a need to find natural preservatives. Arka which is a water distillate consists of essential substances from the crude drug and has longer shelf life. Twak arka possess anti- microbial and anti- oxidant properties and economically cheaper and easily available drug and triphala kwatha being useful in many purposes. In this study an attempt was made to elucidate the preservative action of twak arka in triphala kwatha. Materials and methods: Includes preparation of twak arka, triphala kwatha and conduction of analytical and microbiological study to see the preservative action using SDA and MHA media. Observations and results: Study follows observations over microbial growth of the sample on daily basis where twak arka showed preservative action for 31 days. Aspergillus niger was the fungal growth seen on 32nd day. Discussion: Twak arka owing to its pH, chemical constituents and other properties preserved the triphala kwatha for a stipulated period of time. Conclusion: From the study, it was concluded that the twak arka preserved triphala kwatha without any microbial contamination for 31 days which was added in the concentration of 15%.


2018 ◽  
Vol 22 (2) ◽  
pp. 160
Author(s):  
Hasan Ashari Oramahi ◽  
Elvi Rusmiyanto P. Wardoyo ◽  
Kustiati Kustiati

Bengkirai is one of kind of woods usually used for furnitures and produces lots of woodcuts. This woodcut become the raw material for liquid smoke. The efficacy of liquid smoke produced from bengkirai wood against Phytophthora citrophthora was evaluated. The aim of this research was to evaluate antimicrobial properties of liquid smoke from bengkirai wood against P. citrophthora. Three kinds of liquid smoke were used in three temperatures i.e., 350, 400 and 450ºC. Efficacy of liquid smoke from bengkirai wood for antimicrobial used PDA medium. Simple linear regression was used to measured the effect of liquid smoke concentration to inhibition of P. citrophthora growth. The relationship between the concentration of liquid smoke (X) and inhibition of fungal growth, P. citrophthora (Y) at 350, 400, and 450ºC were Y = 24.51 + 5.27X (r2 = 0.98), Y = 54.31 + 5.53X (r2 = 0,92), and Y = 51.32 + 16.87X (r2 = 0.80). The results showed that the concentration of liquid smoke was significantly different for inhibition of P. citrophthora growth. The higher the concentration the higher the inhibition of microbial growth. The highest inhibition was on liquid smoke of bengkirai wood with temperature pyrolysis of 450ºC and concentration of liquid smoke  of 1% with average value of 100%. IntisariBengkirai merupakan bahan baku pembuatan furniture yang banyak menghasilkan limbah potongan kayu. Limbah potongan kayu ini dapat dijadikan sebagai sumber pembuatan asap cair. Penelitian tentang efikasi asap cair dari kayu bengkirai terhadap Phytophthora citrophthora telah dilakukan. Penelitian ini bertujuan untuk mengevaluasi sifat antimikrobia asap cair kayu bengkirai dalam menghambat pertumbuhan P. citrophthora secara in vitro. Tiga jenis asap cair kayu bengkirai hasil pirolisis pada suhu 350, 400, dan 450ºC. Medium PDA digunakan untuk efikasi asap cair kayu bengkirai terhadap pertumbuhan P. citrophthora. Analisis regresi linier sederhana digunakan untuk mengevaluasi pengaruh konsentrasi terhadap daya hambat pertumbuhan P. citrophthora. Konsentrasi asap cair kayu bengkirai yang digunakan adalah  0; 0,5; 1,0; 1,5 dan 2,0 %, v/v. Hasil penelitian menunjukkan bahwa hubungan antara konsentrasi asap cair (X) dan daya hambat pertumbuhan P. citrophthora (Y) pada suhu pirolisis  asap cair 350, 400, dan 450ºC berturut-turut adalah Y = 24,51 + 5,27X (r2 = 0,98), Y = 54,31 + 5,53X (r2 = 0,92), dan Y = 51,32 + 16,87X (r2 = 0,80). Makin tinggi konsentrasi asap cair kayu bengkirai makin tinggi daya hambat terhadap pertumbuhan P. citrophthora. Daya hambat pertumbuhan P. citrophthora tertinggi (100 %) pada perlakuan asap cair kayu bengkirai yang diproduksi pada suhu pirolisis 450ºC dan konsentrasi 1 %.


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