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Management of Radioactive Waste in Nuclear Medicine
Published in Michael Ljungberg, Handbook of Nuclear Medicine and Molecular Imaging for Physicists, 2022
Contaminated sharp objects such as needles, blood lancets, and glass ampoules should be collected in special containers. Contaminated clothes and bed linen from radionuclide therapy patients at hospital wards should be stored for decay in the interim storage room before being sent to the laundry.
Drug evaluation in children
Published in Evelyne Jacqz-Aigrain, Imti Choonara, Paediatric Clinical Pharmacology, 2021
Evelyne Jacqz-Aigrain, Imti Choonara
Several points need to be considered: For oral administration: aromas, colouring agents, formulations as a function of age (suspensions, chewable tablets, micro-granules, etc.). The instructions for administration must be appropriate and safe. Certain technical difficulties (stability, bitterness of certain compounds, etc) are mentioned.For parenteral drugs, the document stresses the need for establishing properly adapted concentrations of the active agent, permitting a precise and safe administration of the prescribed dosage. For medications in single-use ampoules, one must make sure that the packaging is adapted to the dose.The toxicity of certain excipients can vary as a function of age and between child and adult (e.g., benzoic acid). Depending on the nature of the active principle and the excipients, the use of the medication in newborns may require additional detailed information (e.g., dilution), and perhaps even a new formulation.
Combined Purging Approaches in Autologous Transplantation
Published in Adrian P. Gee, BONE MARROW PROCESSING and PURGING, 2020
Elizabeth J. Shpall, Robert C. Bast, Charles S. Johnston, William P. Peters, Roy B. Jones
The original master stock cultures of the five hybridomas were obtained from Cetus Corporation as frozen ampules. A freeze batch of two ampules, at a concentration of 1 × 107 cells per ampule were prepared for each hybridoma, using 82.5% HL-1 serum-free tissue culture medium (Vintrex, Portland, ME), 10% human serum albumin (Baxter Healthcare Corporation, Glendale, CA), and 7.5% dimethyl sulfoxide (DMSO) (Research Industries Corporation, Salt Lake City, UT). The ampules were stored in liquid nitrogen. All procedures for the hybridomas used serum and endotoxin-free media. One of the two ampules for each antibody was thawed (five ampules total), and the cells placed at a concentration of 2 × 105 cells per milliliter, in T-150 flasks with the HL-1 media supplemented with 1% l-glutamine (Hazelton Research Products, Lenexa, KA), and 500 U/ml penicillin/streptomycin (Gibco Laboratories Inc, Grand Island, NY). The flasks were incubated at 37°C in 5% CO2 for 7 d, and the cells harvested, pooled, and divided into thirty 1-ml aliquots at 5 to 10 × 106 cells per milliliter. The aliquots were frozen in sterile Nunc vials (Intermed Co., Roskilde, Denmark) using HL-1 media, 10% human serum albumin, and 7.5% DMSO, and stored in liquid nitrogen. These vials for each of the five hybridomas (150 vials total) constitute the working master cell bank.
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].
Qualitative risk assessment of follicle stimulating hormone injectable products
Published in Expert Opinion on Drug Delivery, 2020
Douglas T Steinke, Osman H Zarroug, Raj Mathur, Helen Kendrew, Julian Jenkins
This paper may be used to improve patient experience with injectable products and help guide practice to reduce risk when administering FSH. Firstly, practitioners should reflect on risk when choosing injectable products for patients, drawing on the literature, prior experience and personal judgment. Should glass ampoules be used then safety guards must be provided to snap the ampoules. Education is essential prior to the first patient self-injection and good, multiformat support material should be provided. Once these products are given to the patient for self-administration, HCPs have little control over how well they follow the guidance at home, as unlike many other devices, such as inhalers, technique is not usually reviewed regularly to ensure proper effective use. Thus reinforcement of initial education and assessment of injection technique at home should be considered, for example through videoconferencing. In view of the impact of Covid-19 on ART practice, with recommendations to limit the number of persons simultaneously present in the IVF center [20], easier-to-use FSH administration options may be preferable to shorten the time required for training.
International standards for monoclonal antibodies to support pre- and post-marketing product consistency: Evaluation of a candidate international standard for the bioactivities of rituximab
Published in mAbs, 2018
Sandra Prior, Simon E. Hufton, Bernard Fox, Thomas Dougall, Peter Rigsby, Adrian Bristow
A total of sixteen participants from nine different countries kindly contributed to the bioassay data used in the study (Table 12). Amongst the participants 9 were manufacturers, 5 were control laboratories, 1 was a Pharmacopoeia and 1 was a contract research organization. The laboratories are identified with a number, from 1 to 16, that has no relation to the order in the listing. The bioassays performed by each laboratory are summarized in Table 2. The participants received a collaborative study protocol that included bioassay methods and layouts as examples only, instructions for use, template sheets to record data and methodologies. The preparations were shipped at room temperature and participants were instructed to store the samples at −20 °C upon arrival. The ampoules were reconstituted with 1 mL of sterile distilled/deionized water on the day of the assay as per instructions provided. The laboratories were encouraged to use their qualified bioassay methods, including routine controls and qualified “in house” reference standards where possible. Data was requested from three independent assay runs performed on three different days using fresh preparations. Enough ampoules were provided to perform the three assay runs, conduct preliminary assays to establish a suitable working dilution range for the test materials and in case of accidental loss. Typically participants returned data from a total of 9 assays accommodating the three study preparations, the “in house” reference when available and two independent dilution series per sample with some randomization. Table 2 summarizes the bioassays that contributed to the study.