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Plastic Packaging for Parenteral Drug Delivery
Published in Sandeep Nema, John D. Ludwig, Parenteral Medications, 2019
Lloyd Waxman, Frances L. DeGrazio, Vinod D. Vilivalam
A vial is an SVP container with a stopper and a cap, intended to package liquid or a dry powder formulation for either single or multiple doses. Glass vials, typically made up of Type I borosilicate glass, are most commonly used for parenteral applications. However, recently there is increased interest in the use of newer plastics, particularly the cyclic olefins, for parenteral vials as they provide clarity and inertness for biopharmaceutical and biological applications including cell therapy products [11]. When combined with plastic’s inherent break resistance and the need for biologics to be stored and transported at lower temperatures, the future of cyclic olefin-based plastics appears bright. COPs and copolymers (COCs) are considered to be ideal plastics for vial systems because they have glass-like transparency, suitable physical and chemical properties, and the ability to be sterilized.
X-Ray, MRI, and Ultrasound Agents Basic Principles
Published in George C. Kagadis, Nancy L. Ford, Dimitrios N. Karnabatidis, George K. Loudos, Handbook of Small Animal Imaging, 2018
Michael F. Tweedle, Krishan Kumar, Michael V. Knopp
During manufacture, the easiest means to sterilize solutions is through autoclaving of the sealed vials at temperatures >100°C. Therefore high chemical stability is highly desirable. This latter requirement was a primary flaw of metrizamide (Table 15.2). Despite its dramatically improved tolerance relative to its predecessors, imparted by its nonionized nature, a lack of shelf stability in solution meant that metrizamide had to be lyophilized sterile and the user was required to dissolve it in bicarbonate solution. It was therefore an easy target to be replaced by molecules (e.g., iopamidol and iohexol in Table 15.3) that were more stable. Interestingly, XRCAs can achieve their 1 M solubility requirement through innate solubility or through supersaturation, a state of non-equilibrium that is stable for lack of a path to precipitation such as a seed crystal. Terminal heat sterilization also aids in ensuring that microscopic seed crystals are not present in the vial through accidental local evaporation. So, in addition to extreme water solubility, extreme chemical/thermal stability is required to survive the sterilization procedure, plus withstand any hydrolysis over a 2-year expected shelf-life in aqueous solution. De-iodination is inhibited by the >50 kcal aromatic C–I bonds. Note that the water for injection used in these formulations must be strictly free of metals such as copper (Cu), which can catalyze de-iodination. With three I per aromatic ring and relatively compact substituents, I atoms now represent ~50% of the molecular weight of the CA molecules. The leading molecules are now bulk-synthesized in extremely automated manufacturing plants at the 1000 ton/year scale.
Emissions Sources
Published in Winston Chow, Katherine K. Connor, Peter Mueller, Ronald Wyzga, Donald Porcella, Leonard Levin, Ramsay Chang, Managing Hazardous Air Pollutants, 2020
William P. Peel, Charles E. Schmidt
Hg° Diffusion Cell. Known concentrations of Hg° in gas streams were provided using a thermostated mercury diffusion cell. The cell consisted of a Teflon bubbler vessel into which was placed a small vial containing 1.0 g of elemental mercury. The vial was fitted with a 10-mm silicon-rubber septum. The entire vessel was then thermostated at 40.0°C, with a constant flow-through of gas. The output of this cell was found to be 1.48 ± 0.05 ng Hg° · min−1 after several weeks equilibriation. Generally, laboratory experiments were run at 0.165 L · min−1 flow rates, resulting in gas phase Hg° concentrations of 9.0 mg · m−3.
Extractor dimensions affect optimization of laboratory-scale batch solid-liquid extraction of polyphenols from plant material: potato peels as a case study
Published in Chemical Engineering Communications, 2021
Sherif Shaheen, Spyros Grigorakis, Abedalghani Halahlah, Sofia Loupassaki, Dimitris P. Makris
The objective of the optimization of polyphenol extraction from PP was to ascertain whether changes in the dimensions of the extractor, as well as the stirring bar used to provide mixing of the solvent with the solid material (Figure 1), could have a prominent impact on the optimization settings. For this purpose, extractors (glass vials) with volume varying from 25 to 250 mL were used. Such vials represent glassware routinely used on a laboratory scale to carry out batch stirred-tank solid-liquid extractions. For every extractor used, optimization was accomplished by implementing the same experimental design, which was Box-Behnken with three central points. For the experimental design, three independent (process) variables were selected, namely the proportion of water/ethanol (CEtOH), the liquid-to-solid ratio (RL/S), and the stirring speed (SS). In the light of recent investigations, these three variables may be regarded as key factors that can profoundly affect extraction performance (Lakka et al. 2019, 2020). The extraction yield in total polyphenols (YTP) was chosen as the response. The assessment of the models generated was based on ANOVA test (Table 3) and the second degree mathematical equations (models) derived after omitting non-significant terms are given in Table 4. Visualization of these models was portrayed as three-dimensional plots, which were arranged to allow for an at-a-glance comparison (Figure 2). Analytical information on the design points for each extractor tested are given in Table 5. For all models, R2 was ≥ 0.99 and p ≤ 0.0004 (Table 4). This outcome pointed to excellent adjustment of the model to the experimental data, suggesting that the mathematical equations describing the models can be used to make predictions with high reliability.
Optimising workforce efficiency in healthcare during the COVID-19: a computational study of vehicle routeing method for homebound vaccination
Published in Production Planning & Control, 2022
Giustina Secundo, Francesco Nucci, Riad Shams, Francesco Albergo
Since home vaccination involves bringing both the physician and the vaccine to the patient's home, the practical consequences of doing so must be addressed. On the one hand, the physician is forced to drive to the patient’s home. On the other hand, the vaccine must be transported following a safety measure for the vaccine’s short shelf life outside of freezer. Therefore, the challenge is that it must be injected within a short certain time limit. The operation of administering the vaccine before the injection involves a series of administrative operations (i.e. priority patient identification, paper filling). In addition, after the injection, the doctor must wait for a certain amount of time for a possible, although unlikely, adverse reaction of the drug. Consequently, it seems essential for the efficiency of vaccination campaign at home to optimise the timing by respecting all the constraints, with an aim to allow the same doctor to carry out more vaccinations in the shorter period of time, and not to waste doses of vaccine that cannot be administered after a certain time out of the freezer. Therefore, a careful planning of homebound vaccination is required. For this reason, advanced tool to optimise the scheduling of vaccine administration should be adopted. According to the Centres for Disease Control and Prevention (CDC) of the USA and Medicines & Healthcare Products Regulatory Agency of the UK, the characteristics of the vaccine storage can be grouped in different classes as reported in (Santos, Gaspar, and de Souza 2021):The vaccine will arrive frozen and needs to be stored at the same temperature. After defrosting, the vaccine may be thawed in the refrigerator or at room temperature;Un-punctured vials may be kept between at room temperature for a limited time period;Thawed vaccines cannot be refrozen;Vaccine vials may be stored in the refrigerator for a given number of days before vials are punctured. After this period, any remaining vials should be removed from the refrigerator and discarded following manufacturer and jurisdiction guidance for proper disposal.