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Publication
Quality control of primary packaging in the pharmaceutical industry
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| 1.84 MB | Adobe PDF |
Advisor(s)
Abstract(s)
This 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.
Description
Keywords
Pharmaceutical industry Injectables Quality control Primary packaging Chemical and Physical analyses