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Quality control of primary packaging in the pharmaceutical industry

2023-12Master thesis Open access
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dc.contributor.advisorDias, Nilmara
dc.contributor.advisorGuerreiro, Daniela
dc.contributor.authorJerónimo, Tiago Miguel da Costa Novais
dc.date.accessioned2024-03-07T11:34:48Z
dc.date.available2024-03-07T11:34:48Z
dc.date.issued2023-12
dc.description.abstractThis internship was conducted in Hikma, which is a pharmaceutical company located in Sintra, Portugal responsible for the production of injectables for the Portuguese and American market. To ensure that every single product supplied by the company follows the strict specifications imposed by the European Medicines Agency and the Food and Drug Administration, Hikma uses advanced and specialized equipment and laboratory techniques to test the quality and safety of not only the product itself but also its packaging. For this internship, quality control tests were carried out on the primary packaging materials used for the injectables produced by Hikma. The types of primary packaging analysed consist of glass containers, rubber stoppers, flip-offs and twist-offs. As these are all very different types of primary packaging the analyses differ between each of them, in general each type has chemical and physical analysis except flip-offs and twist-offs that require exclusively physical analysis. Of course, this classification serves only to summarize the considerable number of analyses that need to be carried out for all types of primary packaging, as the physical and chemical analysis of each type differs depending on the specific primary packaging to be analysed, some of these analyses consist of the use of spectroscopy, titration and specialized equipment like a texture analyser. Throughout the internship more than 200 batches were analysed and all the analysis carried out were conform, meaning that they were all according to specification.pt_PT
dc.identifier.tid203479300pt_PT
dc.identifier.urihttp://hdl.handle.net/10400.26/50180
dc.language.isoengpt_PT
dc.subjectPharmaceutical industrypt_PT
dc.subjectInjectablespt_PT
dc.subjectQuality controlpt_PT
dc.subjectPrimary packagingpt_PT
dc.subjectChemical and Physical analysespt_PT
dc.titleQuality control of primary packaging in the pharmaceutical industrypt_PT
dc.typemaster thesis
dspace.entity.typePublication
rcaap.rightsopenAccesspt_PT
rcaap.typemasterThesispt_PT
thesis.degree.grantorInstituto Politécnico de Setúbal
thesis.degree.nameMestrado em Engenharia Biológica e Químicapt_PT

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