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Validation of Dry Heat Sterilization and Depyrogenation
Published in James Agalloco, Phil DeSantis, Anthony Grilli, Anthony Pavell, Handbook of Validation in Pharmaceutical Processes, 2021
George Sheaffer, Kishore Warrier
The flame tunnel design utilizes conduction and convection heat transfer in the continuous processing of ampoules. It can process up to 10,000 ampoules per hour. Ampoules are placed on a conveyor belt, washed with water-for-injection, and channeled onto spokes of a rotating wheel. As the wheel rotates, the ampoules are heated to 425°C by natural gas heat for approximately 1 minute. The tunnel has a series of baffles in the chamber to increase the uniformity of heating. The ampoules then pass from the heating chamber into a cooling chamber, where they are gradually cooled by HEPA-filtered air. The cooled ampoules are then filled and flame sealed.
Glass Containers for Parenteral Products
Published in Sandeep Nema, John D. Ludwig, Parenteral Medications, 2019
Robert Swift, Robert Schaut, Carol Rea Flynn, Roger Asselta
An ampoule is a complete one-piece container system entirely made up of glass and produced from tubing. The most common capacity range for ampoules is 0.5–2 mL, although capacities up to 30 mL or larger are possible for special applications in both clear and amber glasses. Multiple styles are available, including (B) stem cut with constriction, (C) stem with open funnel with constriction, and (D) stem sealed with constriction and fine tip. Some sizes and configurations have become de facto standards in certain markets. In addition, the ISO has defined materials, dimensions, capacities, performance, and packaging requirements for glass ampoules intended for injectable products in ISO 9187-1:2010 (36).
Study of the products of the reaction of cobalt(II) acetate with 2-iodoterephthalic acid and 1,10-phenanthroline
Published in Journal of Coordination Chemistry, 2021
Igor E. Uflyand, Valerii V. Tkachev, Vladimir A. Zhinzhilo, Gulzhian I. Dzhardimalieva
The interaction of cobalt(II) acetate with 2-iodoterephthalic acid and phen was carried out by the solvothermal method in DMF. Cobalt acetate tetrahydrate (0.249 g, 1 mmol), 2-iodoterephthalic acid (0.292 g, 1 mmol), and 1,10-phenanthroline monohydrate (0.198 g, 1 mmol) were added to a glass ampoule made of heat-resistant glass. A solvent (20 mL) consisting of water and DMF (1:1) was added to the dry mixture of substances. The ampoule is sealed and placed in a vessel filled with sand and heated at a rate of 20 °C/h to a temperature of 130 °C. The ampoule was maintained at the specified temperature for 72 h and allowed to cool to room temperature. Two layers of solids are formed in the ampoule: in the upper part there are large transparent crystals of red-pink color (1) and a fine-crystalline pink powder (2) in the lower part of the ampoule. The ampoule is carefully opened, the solvent is removed, and the solids are separately collected, washed with distilled water, then, with ethyl alcohol and dried in air. The weight of 1 is 0.068 g (21.1% of the total weight of solid reaction products); 2 is 0.254 g (78.9% of the total weight of solid reaction products).
Novel chalcogenide vanadium complexes with β-diimine ligand: synthesis and structural studies
Published in Journal of Coordination Chemistry, 2019
A. Yu. Konokhova, M. Yu. Afonin, T. S. Sukhikh, S. N. Konchenko
Compound 1 (210 mg, 0.20 mmol) and S (26 mg, 0.81 mmol) were placed into a two-section ampoule described earlier [29]. Toluene (ca. 17 mL) was condensed onto the solids. The ampoule was flame-sealed. The dark brown reaction mixture was stirred for 3 days. After settling of a precipitate formed during that period, the reaction solution was decanted to another section of the ampoule. The precipitate was extracted several times by means of re-condensation of the toluene to the first section and decantation to the second one. That led to formation of 2·0.5C7H8 as red-brown X-ray diffraction (XRD)-quality crystals in the second section. The product was separated from the solution by decantation and dried by cooling the first section by liquid nitrogen. Then the second section was flame-sealed, disconnected and opened in a glovebox. Yield 178 mg (75%). IR-spectrum (KBr, cm−1): 3413 m, 3058 m, 3021 w, 2961 s, 2927 s, 2868 s, 1621 s, 1588 m, 1549 vs, 1532 vs, 1461 s, 1434 s, 1381 vs, 1363 vs, 1315 s, 1255 m, 1176 m, 1100 m, 1058 w, 1023 m, 935 m, 857 m, 795 m, 759 m, 732 w, 697 w, 598 w, 524 w. EA: Calcd for C61.5H86N4S4V2 (%): C, 66.46; H, 7.80; N, 5.04; S, 11.54. Found: C, 66.21; H, 7.90; N, 4.64; S, 12.13.
A visual inspection system of glass ampoule packaging defects: effect of lighting configurations
Published in International Journal of Computer Integrated Manufacturing, 2018
Nathir A. Rawashdeh, Jumana M. Abu-Khalaf, Walid Khraisat, Shireen S. Al-Hourani
Compared to other medicine containers, ampoules have the decisive advantage that medication only comes into contact with glass during its entire storage period. Glass is inert, impermeable and tamper-safe. Ampoules vary in volume from 1 to 30 mL where most ampoules are made from clear glass. In some cases, amber glass is also used to protect sensitive content from UV light. Snap-off ampoules can be broken without any special tools. Often, an ampoule manufacturer integrates a one-point-cut (OPC) on the ampoule neck so that it is easy to break open.