This thesis addresses the crucial theme of contamination control in the pharmaceutical environment, focusing on the importance of design and environmental control in laboratories. The introduction emphasizes the risks associated with the use of harmful active ingredients and the importance of quality standards to ensure the safety of operators and compliance with requirements. In the first chapter of the thesis, various categories of fundamental regulations for the design of cleanrooms in pharmaceutical laboratories are analyzed. These include some regulations on the classification of cleanrooms, biosafety levels, different types of hoods and filter classification. This in-depth analysis provides a comprehensive overview of regulatory provisions governing various critical aspects of the pharmaceutical production environment. The second chapter presents the case study, which corresponds to the project developed during the internship at Deerns Italia S.p.A. company. The analysis focuses on the specificities and the needs of laboratories, considering the activities performed, the active principles handled, and the project structure. This chapter includes a detailed study of a laboratory called "Kilo Lab," dedicated to the production of one kilogram of active ingredient per process. This quantity is necessary for conducting the initial drug quality tests. The "Kilo Lab" is classified according to UNI EN ISO 14644 as ISO 8, with a particle size equal or higher than 0,5 µm and "in operation". In the third chapter, innovative design solutions are developed for each environment, aiming to ensure safety and compliance with current regulations. The adopted approach is based on the integration of regulations and knowledge acquired during my master’s degree and internship, focusing on contaminantion control and the specific needs of different rooms. Starting from the identification of premises and pressure management, the discussion moves on to defining the required airflows and sizing the Air Handling Units (AHUs) and their components.
La tesi affronta il tema cruciale del controllo della contaminazione negli ambienti farmaceutici, focalizzandosi sull’importanza della progettazione e del controllo ambientale nei laboratori. L’introduzione sottolinea i rischi associati all’utilizzo di principi attivi dannosi e l’importanza degli standard qualitativi per garantire la sicurezza degli operatori e la conformità ai requisiti. Nel primo capitolo della tesi vengono analizzate diverse categorie di normative fondamentali per la progettazione delle camere bianche nei laboratori farmaceutici. Queste comprendono alcune normative sulla classificazione delle camere bianche stesse, sui livelli di biosicurezza, sulle diverse tipologie di cappe e sulla classificazione dei filtri. Questa approfondita analisi fornisce un quadro completo delle disposizioni normative che regolano vari aspetti critici dell’ambiente di produzione farmaceutico. Il secondo capitolo presenta il caso studio, che coincide con il progetto sviluppato durante lo stage presso l’azienda Deerns Italia S.p.A. L’analisi si concentra sulle specificità e le esigenze dei laboratori, prendendo in considerazione le attività svolte, i principi attivi trattati e la struttura progettuale. In questo capitolo è contenuto uno studio approfondito di un laboratorio chiamato "Kilo Lab", dedicato alla produzione di un chilogrammo di principio attivo per processo. Questa quantità e quella necessaria per effettuare i primi test di qualità dei farmaci. Il "Kilo Lab" è classificato secondo la normativa UNI EN ISO 14644 come ISO 8, con una dimensione delle particelle pari o superiori a 0,5 µm e nella condizione operativa "in operation". Nel terzo capitolo, si sviluppano soluzioni progettuali innovative per ciascun ambiente, mirando a garantire sicurezza e conformità alle regolamentazioni vigenti. L’approccio adottato si basa sull’integrazione di normative e conoscenze acquisite durante lo studio e lo stage, focalizzandosi sul controllo dei contaminanti e sulle esigenze specifiche delle diverse stanze. Partendo dall’individuazione dei locali e la gestione delle sovrappressioni, si passerà poi alla definizione delle portate richieste e al dimensionamento delle Unità Trattamento Aria (UTA) e dei loro componenti.
Progettazione e controllo ambientale nei Laboratori Farmaceutici
De Poli, Sofia
2022/2023
Abstract
This thesis addresses the crucial theme of contamination control in the pharmaceutical environment, focusing on the importance of design and environmental control in laboratories. The introduction emphasizes the risks associated with the use of harmful active ingredients and the importance of quality standards to ensure the safety of operators and compliance with requirements. In the first chapter of the thesis, various categories of fundamental regulations for the design of cleanrooms in pharmaceutical laboratories are analyzed. These include some regulations on the classification of cleanrooms, biosafety levels, different types of hoods and filter classification. This in-depth analysis provides a comprehensive overview of regulatory provisions governing various critical aspects of the pharmaceutical production environment. The second chapter presents the case study, which corresponds to the project developed during the internship at Deerns Italia S.p.A. company. The analysis focuses on the specificities and the needs of laboratories, considering the activities performed, the active principles handled, and the project structure. This chapter includes a detailed study of a laboratory called "Kilo Lab," dedicated to the production of one kilogram of active ingredient per process. This quantity is necessary for conducting the initial drug quality tests. The "Kilo Lab" is classified according to UNI EN ISO 14644 as ISO 8, with a particle size equal or higher than 0,5 µm and "in operation". In the third chapter, innovative design solutions are developed for each environment, aiming to ensure safety and compliance with current regulations. The adopted approach is based on the integration of regulations and knowledge acquired during my master’s degree and internship, focusing on contaminantion control and the specific needs of different rooms. Starting from the identification of premises and pressure management, the discussion moves on to defining the required airflows and sizing the Air Handling Units (AHUs) and their components.| File | Dimensione | Formato | |
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2024_04_De Poli.pdf
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https://hdl.handle.net/10589/217906