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Container Closure Integrity of Vial Primary Packaging Systems under Frozen Storage Conditions: A Case Study.
Oni YO, Franck J, Evans C, Paniagua D, Kulshrestha A, Mantri RV. Oni YO, et al. PDA J Pharm Sci Technol. 2023 Jan-Feb;77(1):45-52. doi: 10.5731/pdajpst.2021.012719. Epub 2022 Aug 19. PDA J Pharm Sci Technol. 2023. PMID: 35987519
The container closure integrity (CCI)-which is a major requirement for aseptic or sterile packaging systems-at these extremely low temperatures has not been fully understood. For vial-based systems particularly, the commonly used rubber stoppers are expected to lose their …
The container closure integrity (CCI)-which is a major requirement for aseptic or sterile packaging systems-at these extremely low temperatu …
Fungal endophthalmitis associated with compounded products.
Mikosz CA, Smith RM, Kim M, Tyson C, Lee EH, Adams E, Straif-Bourgeois S, Sowadsky R, Arroyo S, Grant-Greene Y, Duran J, Vasquez Y, Robinson BF, Harris JR, Lockhart SR, Török TJ, Mascola L, Park BJ; Fungal Endophthalmitis Outbreak Response Team. Mikosz CA, et al. Emerg Infect Dis. 2014 Feb;20(2):248-56. doi: 10.3201/eid2002.131257. Emerg Infect Dis. 2014. PMID: 24447640 Free PMC article.
We identified 47 cases in 9 states: 21 patients had been exposed to the intraocular dye Brilliant Blue G (BBG) during retinal surgery, and the other 26 had received an intravitreal injection containing triamcinolone acetonide. Both drugs were produced by Franck's Compoundi …
We identified 47 cases in 9 states: 21 patients had been exposed to the intraocular dye Brilliant Blue G (BBG) during retinal surgery, and t …
Determination of ICH-Q3D Elemental Impurity Leachables in Glass Vials by Inductively Coupled Plasma Mass Spectrometry.
Breckenridge L, Oni Y, Evans C, Franck J, Wood S, Xu M, Sahin E, Zacour B. Breckenridge L, et al. PDA J Pharm Sci Technol. 2023 May-Jun;77(3):197-210. doi: 10.5731/pdajpst.2021.012655. Epub 2022 Oct 14. PDA J Pharm Sci Technol. 2023. PMID: 36241213
A study was undertaken to assess the degree of elemental impurity leaching from one type of pharmaceutical glass vial under specific, fixed environmental controls. Multiple buffer systems representing a broad spectrum of possible parenteral drug product formulations were u …
A study was undertaken to assess the degree of elemental impurity leaching from one type of pharmaceutical glass vial under specific, …
Balancing Container Closure Integrity and Aesthetics for a Robust Aseptic or Sterile Vial Packaging System.
Oni Y, Song X, Schrader M, Kulshrestha A, Franck J, Asselta R, Flores-Crespo C, Mantri RV. Oni Y, et al. PDA J Pharm Sci Technol. 2019 Nov-Dec;73(6):572-587. doi: 10.5731/pdajpst.2018.009670. Epub 2019 May 17. PDA J Pharm Sci Technol. 2019. PMID: 31101708
Container closure integrity (CCI) is one of the requirements for a sterile packaging system. For vial-based systems, the capping process is a critical step in creating and ensuring an adequate seal with acceptable CCI. ...A failure to do this could result in high rejects d …
Container closure integrity (CCI) is one of the requirements for a sterile packaging system. For vial-based systems, the capping proc …
[Evolution of the pelvis and hip throughout history: from primates to modern man].
Lapègue F, Jirari M, Sethoum S, Faruch M, Barcelo C, Moskovitch G, Ponsot A, Rabat MC, Labarre D, Vial J, Chiavassa H, Baunin C, Railhac JJ, Sans N. Lapègue F, et al. J Radiol. 2011 Jun;92(6):543-56. doi: 10.1016/j.jradio.2011.04.006. Epub 2011 Jun 12. J Radiol. 2011. PMID: 21704250 French.
Vitamin E levels in premature infants during and after intravenous multivitamin supplementation.
Phillips B, Franck LS, Greene HL. Phillips B, et al. Pediatrics. 1987 Nov;80(5):680-3. Pediatrics. 1987. PMID: 3670969
Vitamin E sufficiency was not maintained in all infants receiving 30% of a vial daily. Of the infants weighing less than 1 kg who received 65% of a vial daily, 31% had serum levels greater than 3.5 mg/dL, whereas no infant weighing less than 1 kg who received 30% of …
Vitamin E sufficiency was not maintained in all infants receiving 30% of a vial daily. Of the infants weighing less than 1 kg who rec …
[No obvious difference in Streptococcus pneumoniae antibiotic resistance profiles--isolates from HIV-positive and HIV-negative patients].
Stephan C, Just-Nübling G, Franck S, Bickel M, Shah PM, Babacan E, Staszewski S. Stephan C, et al. Med Klin (Munich). 2008 Feb 15;103(2):69-74. doi: 10.1007/s00063-008-1011-5. Med Klin (Munich). 2008. PMID: 18270662 German.
PATIENTS AND METHODS: Between January 2001 and December 2005, samples from internal medicine patients of one university hospital laboratory were investigated on culture of Streptococcus pneumoniae and in case of a positive vial, a resistance test was done by agar diffusion …
PATIENTS AND METHODS: Between January 2001 and December 2005, samples from internal medicine patients of one university hospital laboratory …