scholarly journals The in-use stability of the rituximab biosimilar Rixathon®/Riximyo® upon preparation for intravenous infusion

2017 ◽  
Vol 25 (2) ◽  
pp. 269-278 ◽  
Author(s):  
William C Lamanna ◽  
Katharina Heller ◽  
Daniel Schneider ◽  
Raffaele Guerrasio ◽  
Veronika Hampl ◽  
...  
Keyword(s):  
Shelf Life ◽  
Intravenous Infusion ◽  
Room Temperature ◽  
Storage Time ◽  
Peptide Mapping ◽  
Light Exposure ◽  
The European Union ◽  
Biological Stability ◽  
Worst Case ◽  
Trade Names

Purpose The purpose of this study was to evaluate the in-use physicochemical and biological stability of the Sandoz rituximab biosimilar, marketed under the trade names Rixathon® and Riximyo® in the European Union, upon preparation for intravenous infusion. Methods Three batches of Rixathon®/Riximyo® in the final month of their 36 month shelf life were exposed to room temperature and light for 14 days to recapitulate a major temperature excursion. Samples were diluted to the lowest allowable concentration of 1 mg/mL in 0.9% NaCl solution in either polypropylene or polyethylene infusion bags and stored for 14 or 30 days at 5 ± 3℃ followed by an additional 24 h at room temperature to simulate product handling. Samples stored in infusion bags were analyzed using SEC, CEX, non-reducing CE-SDS, peptide mapping and CDC to assess physicochemical and biological stability. Results Analysis of Rixathon®/Riximyo® diluted to the lowest allowable concentration in 0.9% sodium chloride in either polypropylene or polyethylene infusion bags revealed no change in molecular weight variants, charge variants, deamidation, oxidation, overall composition or potency over a 31-day period. Conclusion Physicochemical and biological analyses demonstrate that Rixathon®/Riximyo® stability is not impacted by dilution and formulation conditions required for intravenous infusion, even under worst case conditions with regard to product shelf life, temperature excursion, light exposure, dilution factor and infusion bag storage time over a 31-day period.

scholarly journals Penentuan Umur Simpan Bumbu Masam Keueng Kering Instan Dengan Menggunakan Metode Acelerate Shelf Life Test (ASLT) Model Arrhenius

2019 ◽  
Vol 4 (4) ◽  
pp. 319-328
Author(s):  
Tjut Hedi Agam Akbar ◽  
Yusriana Yusriana ◽  
Syarifah Rohaya
Keyword(s):  
Shelf Life ◽  
Room Temperature ◽  
Storage Time ◽  
Arrhenius Equation ◽  
Aluminum Foil ◽  
Life Estimation ◽  
Quality Degradation ◽  
Acceleration Method ◽  
Shelf Life Estimation ◽  
Semi Empirical

Abstrak : Bumbu Masam Keueng kering instan dibuat dari rempah-rempah seperti cabai merah, bawang merah, bawang putih, asam sunti, kunyit dan jahe. Semua bahan tersebut dicuci kemudianndihaluskan dengannmenggunakan blender dengan penambahan air sebanyak 280 ml selanjutnya bahan dikeringkan dalam oven pengering pada suhu 50oC dalam waktu 9 jam, bahantersebut kemudian dihaluskan kembali menggunakan blender dan dikemas kedalam kemasan alumium foil sebanyak 20 gr. Dalam industri pangan perlu dilakukan penentuan umur simpan sehingga konsumen dapat mengetahui kondisi produk. Umur simpan adalah rentang waktu suatu produk mulai dari proses produksi hingga produk mengalami penurunan mutu atau tidak layak untuk dikonsumsi. Penelitian ini dilaksanakan menggunakan metode akselerasi penentuan umur simpan semi empiris dengan model Arrhenius. Pendugaan umurnsimpan ditentukan melalui perubahan mutu Bumbu Masam keueng kering instan yang dikemas dengan kemasan aluminium foil berdasarkan faktor suhu (S) yang terdiri atas 3 taraf yaitu : S1 = suhu ruang (27-30oC), S2 = 40oC, dan S3 = 50oC dan lama penyimpanan (P) yangnterdiri atas 5 taraf yaitu : P1 = 0 hari, P2 = 14 hari, P3 = 28 hari, P4 = 42 hari, dan P5 = 56 hari. Setiap kemasan sampel (20g) yang dipakai dianalisis sebanyak 2 kali ulangan. Umur simpan masam keueng berdasarkan parameter kritis kadar air jika disimpannpada suhunruang (27-30oC) akan bertahannselama 558 hari, padansuhu 40oC akan bertahan selama 384 hari, dan pada suhu 50oC akan bertahan selama 271 hari.Abstract : Instant dry Masam Keueng seasoning is made of spices such as red chili pepper, garlic, and red onion, sunti acid, turmeric and ginger. All of the ingredients are cleaned and mashed up with blender by adding 280 ml of water, then dried in an oven at 50oC during nine hours, after that re-mashed up in a blender and packed in an aluminum foil packaging for 20gr. In a food industry the shelf life determination is needed so that the consumer can know the condition of the product. Shelf life is a time span of a product from thenbeginning ofnthe production until encounter a quality degradation of unfeasible for consumption. This study is conducted with semi empirical shelf life estimation acceleration method and Arrhenius equation. Shelf life estimation is determined by the quality degradation of instant dry Masam keueng seasoning that is been packaged with aluminum foil packaging based on the temperature factor (S) which consists of three levels specifically: S1 = room temperature (27-30oC), S2 = 40oC. and S3 = 50oC, along with storage time (P) which consists of 5 levels specifically: P1 = 0 day, P2 = 14 days, P3 = 28 days, P4 = 42 days, and P5 = 56 days. Every sample packing (20g) used in analysis is two repetition as much. Thenshelf lifenof masam keueng seasoning basedoon the water content criticalnparameter at room temperature of 27-30oC will last for 558 days, at 40oC will last for 384 days, and at 50oC will last for 271 days.

Effect of Packaging Materials on the Shelf Life of Bamboo Shoots

2012 ◽  
Vol 200 ◽  
pp. 540-544 ◽  
Author(s):  
Jian Wei Zhou ◽  
Guo Hua Zhang ◽  
Hong Yan Hu ◽  
Zhen Lin Wang
Keyword(s):  
Shelf Life ◽  
Room Temperature ◽  
Storage Time ◽  
Sugar Content ◽  
Barrier Properties ◽  
Ash Content ◽  
Total Sugar ◽  
Packaging Materials ◽  
Total Sugar Content ◽  
Bamboo Shoots

The effect of different barrier properties packaging materials (PE, PET, PVC) on the shelf life of the shelled fresh bamboo shoots were studied. The effection of packaging materials were assessed by the sensory evaluation and the changes of their moisture content, ash content, total sugar content and protein content during storage time. The results showed that the shelled bamboo shoots in conditions at 10 °C with the packaging of PVC and PET have the better quality and longer shelf life than which with the packaging of PE and no packaging at the room temperature.

Degradation in a Methyl-phenyl Co-Polymeric Polysilane for LED Applications

2003 ◽  
Vol 769 ◽  
Author(s):  
Asha Sharma ◽  
Deepak ◽  
Monica Katiyar ◽  
Satyendra Kumar ◽  
V. Chandrasekhar ◽  
...  
Keyword(s):  
Thin Films ◽  
Molecular Weight ◽  
Light Source ◽  
Room Temperature ◽  
Light Exposure ◽  
Room Temperature Photoluminescence ◽  
Pl Spectrum ◽  
Pl Intensity ◽  
Methyl Phenyl

AbstractThe optical degradation of polysilane copolymer has been studied in spin cast thin films and solutions using light source of 325 nm wavelength. The room temperature photoluminescence (PL) spectrum of these films show a sharp emission at 368 nm when excited with a source of 325 nm. However, the PL intensity deteriorates with time upon light exposure. Further the causes of this degradation have been examined by characterizing the material for its transmission behaviour and changes occurring in molecular weight as analysed by GPC data.

Antioxidant activity of cookiessupplemented with sugarbeet dietary fiber

2011 ◽  
pp. 151-157 ◽  
Author(s):  
Marijana B. Saka ◽  
Julianna F. Gyura ◽  
Aleksandra Mišan ◽  
Zita I. Šereš ◽  
Biljana S. Pajin ◽  
...  
Keyword(s):  
Antioxidant Activity ◽  
Shelf Life ◽  
Dietary Fiber ◽  
Wheat Flour ◽  
Room Temperature ◽  
Antioxidant Activities ◽  
Radical Scavenging Activity ◽  
Antioxidant Properties ◽  
Radical Scavenging ◽  
Functional Characteristics

The antioxidant activity of cookies prepared by the addition of sugarbeet dietary fibers was investigated in order to estimate their influence on functional characteristics and shelf-life of cookies. Treated fiber (TF) was obtained from sugarbeet by extraction with sulfurous acid (75 °C at pH = 5.7during 60 min) and treatment with hydrogen peroxide (20 g/LH2O2 at pH = 11 during 24 h). The fiber obtained was dried (80 °C), ground and sieved. TF was investigated in comparison with commercially available Fibrex®. The cookies were prepared by the addition of 0, 7, 9 and 11% of sugarbeet dietary fiber as a substitute for wheat flour in the formulation of cookies. The antioxidant properties of cookies were tested every 7 days using a DPPH (1,1-diphenyl-2-picrylhydrazyl) radical scavenging activity test during 6 weeks of storage at room temperature (23 ± 1 ºC). The obtained results indicated that substitution of wheat flour with Fibrex® in the formulation of cookies upgraded the antioxidant activity, i.e. the functional characteristics of Fibrex®-enriched cookies and could prolong their shelf-life. In contrast, TF did not increase the antioxidant activity of TF-enriched cookies. The better antioxidant activities of Fibrex®-enriched cookies could be attributed to the presence of ferulic acid.

scholarly journals Pengaruh Perlakuan Waktu dan Suhu Penyimpanan Dingin terhadap Mutu Kubis Bunga (Brassica Oleracea Var. Botrytis L.)

2019 ◽  
Vol 8 (1) ◽  
pp. 138
Author(s):  
Chyntia Wulandari Eka Saputri ◽  
I. A. Rina Pratiwi Pudja ◽  
Pande Ketut Diah Kencana
Keyword(s):  
Weight Loss ◽  
Shelf Life ◽  
Cold Storage ◽  
Storage Time ◽  
Consumption Rate ◽  
Storage Temperature ◽  
Treatment Time ◽  
O2 Consumption ◽  
Damage Level ◽  
Four Levels

Tujuan dari penelitian ini adalah untuk menentukan waktu perlakuan optimal dan suhu penyimpanan dingin untuk mutu kubis bunga. Penelitian ini menggunakan rancangan acak lengkap (RAL) yang terdiri dari dua faktor, faktor pertama adalah suhu yang digunakan dan faktor kedua adalah waktu selama show case. Faktor pertama terdiri dari dua level, yaitu (P1): show case temperature 8oC, dan (P2): show case temperature 15oC dan tambah kontrol (P0). Faktor kedua terdiri dari empat level, yaitu (A0): penyimpanan selama 0 jam, (A1): penyimpanan selama 12 jam, (A2): penyimpanan selama 16 jam, (A3): penyimpanan selama 20 jam dan diulang untuk 3 kali ulangan. Kubis bunga sebagai kontrol disimpan pada suhu kamar (28 ± 1 ?). Parameter kualitas yang diamati dalam penelitian ini termasuk penurunan berat badan, tingkat konsumsi O2, warna (warna berbeda), uji organoleptik termasuk umur simpan dan tingkat kerusakan. Hasil penelitian menunjukkan parameter penurunan susut bobot, laju konsumsi O2, warna, umur simpan, tingkat kerusakan pada suhu perlakuan suhu terbaik adalah suhu 8 ? dan waktu penyimpanan 20 jam (P1A3).Kata kunci: kembang kol, waktu penyimpanan, suhu penyimpanan dingin   The purpose of this study was to determine the optimal treatment time and cold storage temperature for the quality of cabbage flowers. This study uses a completely randomized design (CRD) consisting of two factors, the first factor is the temperature used and the second factor is the time during the showcase. The first factor consists of two levels, namely (P1): showcase temperature of 8oC, and (P2): showcase temperature of 15oC and added a control (P0). The second factor consists of four levels, namely (A0): storage for 0 hours, (A1): storage for 12 hours, (A2): storage for 16 hours, (A3): storage for 20 hours and repeated for 3 replications. Flower cabbage as control was stored at room temperature (28 ± 1 ?). The quality parameters observed in this study included weight loss, O2 consumption rate, color (color different), organoleptic tests including shelf life and damage level. The results showed the parameters of weight loss, O2 consumption rate, color, shelf life, damage rate at the best temperature of 8 ? and storage time of 20 hours (P1A3). Keywords: cauliflower, storage time, cold storage temperature

scholarly journals Responses of quinoa (Chenopodium quinoa Willd.) seeds stored under different germination temperatures

2017 ◽  
Vol 39 (1) ◽  
pp. 83 ◽  
Author(s):  
Andressa Strenske ◽  
Edmar Soares de Vasconcelos ◽  
Vanessa Aline Egewarth ◽  
Neusa Francisca Michelon Herzog ◽  
Marlene De Matos Malavasi
Keyword(s):  
Room Temperature ◽  
Storage Time ◽  
Chenopodium Quinoa ◽  
Seed Vigor ◽  
Continuous Darkness ◽  
Experimental Conditions ◽  
Growing Seasons ◽  
Germinating Seeds ◽  
Germinated Seeds ◽  
Plot Design

In this experiment, we assessed the germination and vigor of quinoa seeds packed in paper bags and stored at room temperature for 36, 85, 119, 146, 177 and 270 days. The seeds were harvested under experimental conditions in Marechal Candido Rondon, Paraná, during the 2012/13 growing seasons. Four replicates of 100 seeds each were established for each storage time, and the seeds were evaluated, on paper, based on the BOD under the following experimental temperature conditions: alternating temperatures of 20 and 30°C and a constant temperature of 25°C. The seeds from both treatments were subject to seven-hour photoperiods and 25°C under continuous darkness. The germinated seeds were counted daily for eight days after sowing, and we evaluated the percentages of normal and abnormal seedlings and the germination index. The experimental design was completely randomized using a split-plot design. Increasing the storage time decreased the percentage of germinated seeds and seed vigor due to the increased number of abnormal seedlings. Over the 430-day study period, quinoa seed germination completely declined under the experimental conditions. The final number of germinating seeds should be evaluated 7 days after the beginning of the germination test. 

scholarly journals Materials for Future Quantum Dot-Based Memories

2013 ◽  
Vol 2013 ◽  
pp. 1-6 ◽  
Author(s):  
T. Nowozin ◽  
D. Bimberg ◽  
K. Daqrouq ◽  
M. N. Ajour ◽  
M. Awedh
Keyword(s):  
Cross Sections ◽  
Room Temperature ◽  
Storage Time ◽  
Thermal Emission ◽  
Current Status ◽  
Strong Electron ◽  
Self Organized ◽  
Hole Confinement ◽  
Storage Times ◽  
Capture Cross Sections

The present paper investigates the current status of the storage times in self-organized QDs, surveying a variety of heterostructures advantageous for strong electron and/or hole confinement. Experimental data for the electronic properties, such as localization energies and capture cross-sections, are listed. Based on the theory of thermal emission of carriers from QDs, we extrapolate the values for materials that would increase the storage time at room temperature to more than millions of years. For electron storage, GaSb/AlSb, GaN/AlN, and InAs/AlSb are proposed. For hole storage, GaSb/Al0.9Ga0.1As, GaSb/GaP, and GaSb/AlP are promising candidates.

Mineral Oil-Chitosan Emulsion Coatings Affect Quality and Shelf-Life of Coated Eggs during Refrigerated and Room Temperature Storage

2011 ◽  
Vol 76 (4) ◽  
pp. S262-S268 ◽  
Author(s):  
Damir D. Torrico ◽  
Hong Kyoon No ◽  
Witoon Prinyawiwatkul ◽  
Marlene Janes ◽  
José A.H. Corredor ◽  
...  
Keyword(s):  
Shelf Life ◽  
Room Temperature ◽  
Mineral Oil ◽  
Room Temperature Storage ◽  
Quality And Shelf Life ◽  
Temperature Storage

The Evolution Behavior of Defects in the Nanofilms of W/Cu and W Probed by Doppler Broadening Positron Annihilation Spectroscopy

2017 ◽  
Vol 373 ◽  
pp. 104-107
Author(s):  
Ling Wang ◽  
Ai Hong Deng ◽  
Kang Wang ◽  
Yong Wang ◽  
Xiao Bo Lu ◽  
...  
Keyword(s):  
Magnetron Sputtering ◽  
Positron Annihilation ◽  
Room Temperature ◽  
Storage Time ◽  
Positron Annihilation Spectroscopy ◽  
Doppler Broadening ◽  
Radio Frequency Magnetron Sputtering ◽  
Helium Ions ◽  
Near Surface ◽  
Evolution Behavior

W/Cu multilayer nanofilms and pure W nanofilms were prepared in pure Ar and He/Ar mixing atmosphere by radio frequency magnetron sputtering method. The defect evolution of the samples was characterized by Doppler broadening positron annihilation spectroscopy (DB-PAS).The results show that plenty of defects can be produced by introducing helium (He) into W/Cu multilayer nanofilms. With the natural storage time increasing, the helium located in the near surface of W/Cu multilayer nanofilm would be released gradually and induce the coalescence of the helium related defects due to the diffusion of the helium and defects. In addition, the pure W nanofilms were irradiated by 30 keV helium ions and 40 keV hydrogen (H) ions in sequence at room temperature. From the DB-PAS analysis, it can be shown that a large number of vacancy-type defects are produced due to the He and/or H irradiation. H ions would be trapped by He related defects and produced He-H-V complexes.

Long-term Room Temperature Instability in Thermal Conductivity of InGaZnO Thin Films

MRS Advances ◽  
2016 ◽  
Vol 1 (22) ◽  
pp. 1631-1636 ◽  
Author(s):  
Boya Cui ◽  
D. Bruce Buchholz ◽  
Li Zeng ◽  
Michael Bedzyk ◽  
Robert P. H. Chang ◽  
...  
Keyword(s):  
Thin Films ◽  
Thermal Conductivity ◽  
Room Temperature ◽  
Storage Time ◽  
Laser Deposition ◽  
Low Oxygen ◽  
X Ray Diffraction ◽  
3Ω Method ◽  
X Ray

ABSTRACTThe cross-plane thermal conductivities of InGaZnO (IGZO) thin films in different morphologies were measured on three occasions within 19 months, using the 3ω method at room temperature 300 K. Amorphous (a-), semi-crystalline (semi-c-) and crystalline (c-) IGZO films were grown by pulsed laser deposition (PLD), followed by X-ray diffraction (XRD) for evaluation of film quality and crystallinity. Semi-c-IGZO shows the highest thermal conductivity, even higher than the most ordered crystal-like phase. After being stored in dry low-oxygen environment for months, a drastic decrease of semi-c-IGZO thermal conductivity was observed, while the thermal conductivity slightly reduced in c-IGZO and remained unchanged in a-IGZO. This change in thermal conductivity with storage time can be attributed to film structural relaxation and vacancy diffusion to grain boundaries.

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