A research report submitted to the Faculty of Health Sciences, University of the Witwatersrand, in partial fulfilment of the requirements for the degree of Master of Medicine in the branch of Anaesthesiology Johannesburg, 2019 / Background Anaesthesia frequently involves administration of refrigerated intravenous drugs to patients. Often overlooked, maintenance of the cold chain forms a key component of pharmacovigilance for anaesthetists. However the South African national Department of Health guidelines on: “Cold Chain and Immunisation Operations Manual”, does not detail specific requirements for medically validated cold boxes. Consequently the risk of iatrogenic harm to patients from heat-sensitive pharmaceuticals in inappropriately temperature regulated cold boxes exists. Methods The research design was that of a descriptive, prospective and contextual study. Part I study population comprised the ambient air temperatures of the refrigerator and cold boxes used for storage of heat-sensitive pharmaceuticals in theatre at CHBAH taken at one minute intervals over eight hours. Part II study population was newly purchased cold boxes and cold packs for the purpose of assessing individual cold box thermal performance over eight hours. Results In Part I, only a single cold box (polystyrene box number 19) was able to maintain the recommended temperature range of 2 − 8°C for the eight hour period (4.35%). The refrigerator temperature time plot showed a significant deviation of temperature at approximately 30 minutes. In Part II, only fabric and polystyrene cold boxes with three cold packs in situ were able to maintain the recommended temperature of 2 − 8°C. Conclusion This study highlighted the failure of non-medically validated cold boxes to reliably maintain the temperature of heat-sensitive pharmaceuticals. / E.K. 2019

Diss. (sammanfattning) Linköping : Univ., 2001. / Härtill 4 uppsatser.

Diss. (sammanfattning) Stockholm : Karolinska institutet, 2006. / Härtill 5 uppsatser.

Diss. (sammanfattning) Stockholm : Karolinska institutet, 2009.

Submitted by Johnny Rodrigues (johnnyrodrigues@ufcg.edu.br) on 2018-04-13T17:35:52Z No. of bitstreams: 1 LEILA APARECIDA ALVIM DE PAULA FERREIRA - DISSERTAÇÃO PPG-CEMat 2014..pdf: 2101894 bytes, checksum: 086e0e07fb7a86bb4092c49f395ed931 (MD5) / Made available in DSpace on 2018-04-13T17:35:52Z (GMT). No. of bitstreams: 1 LEILA APARECIDA ALVIM DE PAULA FERREIRA - DISSERTAÇÃO PPG-CEMat 2014..pdf: 2101894 bytes, checksum: 086e0e07fb7a86bb4092c49f395ed931 (MD5) Previous issue date: 2014-07-18 / Este trabalho teve como objetivo a avaliação físico-química, morfológica e estrutural das bolsas de Policloreto de Vinila (PVC) para acondicionamento de sangue e hemocomponentes. As amostras de bolsas plásticas Nacionais e do Exterior utilizadas para este estudo foram selecionadas no Sistema de Dados da ANVISA - DATAVISA entre as bolsas regularizadas junto à ANVISA. As bolsas constituídas de PVC foram caracterizadas por Espectroscopia na Região de Infravermelho com Transformada de Fourier (FTIR), Difração de Raios X (DRX), Microscopia Óptica (MO), Microscopia Eletrônica de Varredura (MEV)/ Espectroscopia por Energia Dispersa de Raios X (EDS), Microscopia de Força Atômica (MFA) e Ensaios Mecânicos (Tração). As análises foram realizadas no Laboratório de Desenvolvimento e Avaliação de Biomateriais (CERTBIO). De acordo com os resultados observados no ensaio de FTIR, pode-se afirmar que todos os componentes apresentam grupos funcionais semelhantes. No DRX foi observado que as amostras apresentaram um perfil de material com caráter semicristalino. Na MO e MEV observou-se um lado mais liso e outro mais rugoso com algumas irregularidades na superfície da amostra. Conforme o ensaio de EDS, os elementos químicos identificados, bem como a concentração dos mesmos, demonstrou que as bolsas seguem um mesmo critério de composição. Baseado nos resultados de ensaios mecânicos para ambos fabricantes, as bolsas de sangue sem anticoagulante apresentaram menor deformação em relação as bolsas de sangue com anticoagulante. Todas as bolsas apresentaram comportamento de material viscoelástico. Desta forma, pode-se concluir que todos os ensaios de caracterização utilizados neste trabalho foram relevantes para avaliação da qualidade das bolsas plásticas para acondicionamento de sangue e hemocomponentes existentes no mercado, considerando os requisitos gerais e específicos estabelecidos nas normas e legislações vigentes. / This research has the objective the physical chemical, morphological and structural evaluation of Polyvinyl Chloride (PVC) bags for blood filling and hemocomponentes. The samples from national and imported blood bags used for this research were selected through ANVISA database from blood bags regularly released by that. The PVC blood bags were characterized by Fourier transform Infrared (FTIR), X-ray Diffraction (XRD), optical microscopy (OM), scanning electron microscopy (SEM), energy dispersed spectroscopy X-ray (EDS), Atomic Force Microscopy (AFM) and Mechanical Testing. The analyses were performed on Biomaterial development and evaluation lab (CERTBIO). On Fourier transform Infrared (FTIR) it was observed that all components show chemical similarity. On XRD was noticed that the samples have showed a semi crystalline characteristics. On OM and SEM it was noticed that the sample has a smooth side and other with sprinkles on surface. ON EDS assay it was observed conformity on chemical compounds identified as well as on their strength. It demonstrates that blood bags follow the same composition criteria. Based on mechanical tests results for both manufacturers, the blood bags without anticoagulant showed less deformation compared to blood bags with anticoagulant. All bags showed viscoelastic material behavior. Thus, we can conclude that all characterization tests used in this study were relevant to assessing the quality of the bags that are used as containers of blood and its components existing on the market, considering the general and specific requirements established in rules and regulations.