2026-04-13T01:14:57Zhttps://recercat.cat/oai/requestoai:recercat.cat:2117/1739782025-07-23T06:45:37Zcom_2072_1033col_2072_452951
Root cause analysis and process improvement of a nasal spray
Mozota Martínez, Aina
Àrees temàtiques de la UPC::Enginyeria mecànica
Machine design
Maquinària -- Disseny
The following project has been developed in a pharmaceutical industrial environment at Merck,
Darmstadt, specifically in the production and packaging of a nasal spray, which takes place at FAMAR,
in Alcorcón. After receiving multiple complaints in which it was described that the product was open
and its content spilled, Merck decided to perform a root-cause analysis of the aforementioned problem
and to implement a CAPA plan in order to fix it, which consists in the implementation of a set of
preventive and corrective measures, and at the same time, to improve the functioning of the
production line by acting upon the deficiencies found in the analysis.
The methodology followed to find the root of the problem has been a root cause analysis employing
many analysis methods. First of all, a risk assessment of this type of incident has been done, as well as
an exhaustive investigation of the process that the product takes in the production and the assurance
of the Good Manufacturing Practices (GMP) and a study of the defective samples and the comparison
against the retain samples. Concomitantly, a 6M (Ishikawa diagram) study has been developed in order
to determine which factors have had an influence on the result and which have not and the data of the
batches produced has been reviewed, including those batches with and without defective samples.
Lastly, an identical case has been studied and an investigation action has been implemented.
A sole root cause could not be found, however many contributing factors have been found, which has
allowed, on one hand, to come up with corrective actions and implement them to fix the problem, and
on the other hand, to reach preventive actions in order to avoid similar cases in the future, and once
the weak spots and lacks of the production line were revealed, improve upon them.
An environmental study can also be found in this project, where the impact of the development of the
project upon the environment has been evaluated, taking into account the type of material that is used
to package the product as well as the reagent employed to synthetize the product and its risks, and
finally the carbon footprint that meant performing the project, analysing among other things, the
energy consumed and the pollution created.
Finally, an economical study of the cost of the project has been done. In this analysis, the costs of the
used materials, products, power consumption, human resources and lastly the cost of the visits to the
production site have been estimated.
Outgoing
2018-10-23
Bachelor thesis
Restricted access - author's decision
Universitat Politècnica de Catalunya