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From Formulation Design to Production: The Scale-Up Process
Published in Heather A.E. Benson, Michael S. Roberts, Vânia Rodrigues Leite-Silva, Kenneth A. Walters, Cosmetic Formulation, 2019
Slowly over the last 20 years we have gone through all sorts of equipment, from the gas burner under a 44-gallon bin to steam and chilled water jacketed tanks. From hand cartoning to operating three auto-cartoners. Yet it matters not how much new automated equipment one amasses – the next customer will have found a container and formula that requires a multitude of low-tech labour to get it right. If the future product numbers are there, we will invent the next piece of equipment. So far, we have found and used the best equipment that our budget will allow. And of course, everything has been rebuilt or modified to cater to as many different types of products as possible.
Biomarker for Energy Intake
Published in Dale A. Schoeller, Margriet S. Westerterp-Plantenga, Advances in the Assessment of Dietary Intake, 2017
A typical protocol for a REE measurement with a ventilated-hood system takes 30 minutes. To eliminate effects of subject habituation to the testing procedure, the respiratory measurements over the first 10 minutes are discarded and the following 20 minutes are used to calculate REE. The criterion for the chosen time interval is the reproducibility of the calculated REE value. Longer measurements tend to result in higher values because subjects become restless. Reproducibility of REE measurement is influenced by the within-machine variability of the ventilated-hood system (Adriaens et al. 2003). Calibration procedures include standard gases covering the span of the oxygen and carbon dioxide analyzers, and a standard volume for calibration of the hood ventilation. Overall performance of a ventilated-hood system can be checked with methanol burning (Schoffelen et al. 1997). Methanol 99.8% is combusted by using a gas burner, placed on a calibrated balance under the hood. The methanol burner is set at a burning rate equivalent to the oxygen consumption and carbon dioxide production of the average subject and the burning time is comparable to a typical hood measurement.
Efficacy of delayed administration of sargramostim up to 120 hours post exposure in a nonhuman primate total body radiation model
Published in International Journal of Radiation Biology, 2021
Yifei Zhong, Mylene Pouliot, Anne-Marie Downey, Colleen Mockbee, Debasish Roychowdhury, Wieslaw Wierzbicki, Simon Authier
The following tissues were collected at necropsy from all animals (including unscheduled terminations or moribund animals) for microbiological analysis: liver (medial lobe), lungs (right caudal lobe and left cranial lobe separately), spleen (part of remaining tissues), kidney (right), heart (apex), and brain (left hemisphere). Organ samples were placed on a sterile plate for manipulations. A selected area at the surface of the tissue sample was burned to eliminate possible surface contaminant. The burning of the area was performed by using a spatula soaked in 70% ethanol and heated by the gas burner flame until the spatula is red. A sterile culture swab was inserted in the tissue sample through the burned surface and inserted into a sterile tube for isolation and identification of aerobic and anaerobic bacteria and antibiogram. Culture swabs were stored refrigerated (2–8 °C) or kept on wet ice pending processing.
Development of syringes and vials for delivery of biologics: current challenges and innovative solutions
Published in Expert Opinion on Drug Delivery, 2021
Saki Yoneda, Tetsuo Torisu, Susumu Uchiyama
Various container types are available for parenteral drugs today. Figure 1 shows the overall history of container development. The history of ampoules and vials is extensive; glass vials emerged around 1850, and ampoules were developed in the 1890s [1]. Ampoules are made of borosilicate glass (borosilicate-hard glass). After filling the chemical solution, the ampoule tip is sealed using a gas burner and stored. It is positioned as the cheapest and most tightly sealed container among containers. Glass ampoules were commonly used during World War II for storing penicillin. However, ampoules pose a risk of contamination because cracked glass pieces can enter the formulation while opening the ampoule. Vials are generally more convenient than ampoules and are now a major container type for both lyophilized and liquid products. Liquid or reconstituted drugs in vials are aspirated using a syringe with a needle on administration to a patient. Possible contamination during the reconstitution and/or aspiration was a concern [2,3]. Furthermore, the preparation was burdensome for medical workers. To overcome these inconveniences of vials, a dosage form called Ampin, which is briefly the ampoule with a needle, was developed [4].