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1.
J Hazard Mater ; 452: 131334, 2023 Jun 15.
Artigo em Inglês | MEDLINE | ID: mdl-37023573

RESUMO

A new power-to-X desulfurization technology has been examined. The technology uses only electricity to oxidize the hydrogen sulfide (H2S) found in biogas to elemental sulfur. The process works by using a scrubber where the biogas comes into contact with a chlorine containing liquid. This process is capable of removing close to 100% of H2S in biogas. In this paper a parameter analysis of process parameters has been carried out. In addition a long term test of the process has been performed. It has been found that the liquid flow rate has a small but notable influence on the process' performance on removing H2S. The efficiency of the process largely depends on total amount of H2S flowing through the scrubber. As the H2S concentration increases, the amount of chlorine required for the removal process is also increased. A high amount of chlorine in the solvent may lead to unwanted side reactions.

2.
PDA J Pharm Sci Technol ; 73(2): 170-180, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30361284

RESUMO

The regulatory expectations introduced by the U.S. Food and Drug Administration in 1999, ICH Q5C, the revised draft of Annex 1, Eudralex volume 4 for consultation, and the recent update of USP general chapters 1207.1 and 1207.2 regarding container closure integrity (CCI) testing have created a need for further development of testing methods, although there are no universally accepted methods to test and evaluate the CCI of a biopharmaceutical drug product. Each testing method and principle has merits and demerits.This paper will present a simple approach to be used in method validation of CCI testing based on headspace oxygen analysis for freeze-dried biopharmaceutical drug products in vials, as well as a method for testing and verifying positive control vials. The model is based on Fick's law of diffusion and is empirically corrected to account for Knudsen diffusion in smaller defect sizes. The model considers storage conditions of the vials, allowing for testing of vials stored under anaerobic and near-sealing pressure conditions and different temperature conditions, as well as testing at different time points. Using this approach based on headspace oxygen analysis, the minimum timeframe for leak detection is dependent on the volume of the object tested, but standard vial sizes have shown that leak sizes of 0.2 µm can be detected within hours of vial stoppering with the model developed. CCI testing by headspace oxygen analysis using this approach can be done quickly and non-destructively. This method can prove its effectiveness in demonstration of a protective critical barrier (CCI) for a biopharmaceutical drug product during real-time situations of manufacturing, transportation, registered storage conditions, etc. (life-cycle approach).LAY ABSTRACT: The recent update of the guideline, USP general chapters 1207.1 and 1207.2, regarding container closure integrity (CCI) testing, has created a need for further development of testing methods. The new methods applied should be deterministic, i.e., describe predefined detection limits and objective quantitative data. Deterministic leak test methods are methods for which the leakage event being detected or measured is based on phenomena that follow a predictable chain of events.At present, there is no universally accepted method to test and evaluate the CCI of a biopharmaceutical drug product.This paper will present a simple model-based method based on headspace oxygen analysis for freeze-dried biopharmaceutical drug products in vials, as well as a method for testing and verifying positive control vials. Positive controls are vials with a known defect, e.g., an inserted micropipette.The model considers storage conditions of the vials, allowing for testing of vials stored under different pressure and temperature conditions, as well as testing at different time points. CCI testing by headspace oxygen analysis using the new approach can be done quickly and without destruction of the vials. This method can prove its effectiveness in demonstration of a protective critical barrier (CCI) for a biopharmaceutical drug product during real situations of manufacturing, transportation, registered storage conditions, etc.


Assuntos
Produtos Biológicos/normas , Contaminação de Medicamentos/prevenção & controle , Embalagem de Medicamentos/normas , Oxigênio/análise , Difusão , Armazenamento de Medicamentos , Liofilização , Guias como Assunto , Lasers , Modelos Teóricos , Temperatura , Fatores de Tempo , Estados Unidos , United States Food and Drug Administration , Estudos de Validação como Assunto
3.
Dan Med J ; 62(9)2015 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-26324084

RESUMO

INTRODUCTION: Undergraduate research among medical students is essential in the education of future physicians and scientists. This study aimed to evaluate the scientific yield of extracurricular undergraduate research among medical students. METHODS: Medical students at the University of Copenhagen who completed an extracurricular research year between January 2004 and June 2013 were evaluated through a manual search in PubMed MEDLINE. The primary focus was the number of peer-reviewed, published articles. RESULTS: Of the 363 included students, 3.1% did their research in 2004-2005 compared with 46.5% in 2012-2013. After three years, 70.4% of the students had published a peer-reviewed article, and of all the 363 students, 36.5%, had published as a first author. In total, 87.7% had a medical specialty as their research area versus a surgical specialty. Most students were involved in cardiology (14.1%). Cardiology was also associated with the greatest scientific yield with a median number of 0.8 publications per year after the students concluded their undergraduate research period. Three or more years after concluding their undergraduate research, 32.8% of the students had continued with research in the context of a PhD programme. CONCLUSION: Overall, the number of medical students who engaged in extracurricular research followed an increasing trend, and more than two-thirds of these students published a peer-reviewed paper within three years. Cardiology was the most popular specialty and also the specialty with the greatest scientific yield. A third of the undergraduate research students continued doing research in the context of a PhD programme.


Assuntos
Educação de Graduação em Medicina/tendências , Revisão da Pesquisa por Pares/tendências , Estudantes de Medicina/estatística & dados numéricos , Adulto , Cardiologia , Dinamarca , Educação de Graduação em Medicina/estatística & dados numéricos , Humanos , Medicina
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