Unit:
Κατεύθυνση Ανάπτυξη Νέων Φαρμάκων: Έρευνα, Κυκλοφορία και ΠρόσβασηLibrary of the School of Health Sciences
Author:
Katrahouras Anastasios
Supervisors info:
Κων/νος Συρίγος, Καθηγητή, Ιατρική Σχολή, ΕΚΠΑ
Αδάμ Αδαμόπουλος, Επίκουρο Καθηγητή, Ιατρική Σχολή, ΕΚΠΑ
Ανδριανή Χαρπίδου, Διδάκτωρ, Ιατρική Σχολή, ΕΚΠΑ
Original Title:
Έλεγχος μικροβιακού φορτίου φαρμακευτικών προϊόντων, παραγομένων από τα στρατιωτικά φαρμακευτικά εργαστήρια
Translated title:
Microbiological contamination control of pharmaceutical products, produced in militairy pharmaceutical laboratories
Summary:
Microbiological contamination control of pharmaceutical products is a crucial parameter in the area of Pharmaceutical Manufacturing and is vital for patient΄s health and drug΄s quality. Techniques of contamination control, where can be described in Pharmacopoeias and in related bibliography, can offer a clear picture of the number and the genre of microbiological contamination.
In the experimental part of the present dissertation, tests took place for validation of the credibility of the methods for control of contamination, in contaminated expectorant syrup of HCL Bromhexine 8mg/5ml with bacterium of Salmonella Typhi ATCC™ 6539™. Firstly, culture media were produced and underwent quality control. A sample from contaminated syrup cultivated into selective culture media (Rappaport Vassiliadis Broth, XLD Agar) for colonies formation. Nextly bacteria of the formatted colonies stained by Gram method and observed in microscopic device. At the end, a sample from colonies properly modified, poured into RapID ONE panel and conclusions were drawn based on the color changes of the dehydrated reactants.
In the selective culture media XLD Agar, the colonies that formed, had translucent surrounding and black center, characteristic in Salmonella spp. Microscopic findings had shown rod-shaped and red colored cells due to gram staining, also characteristic for these species. RapID ONE Test specified 99,78% the bacteria Salmonella Typhi, which we contaminated the syrup in the beginnings of the experimental process. In conclusion, the above results validated the credibility of the methods for control of contamination and confirmed the accuracy of the described tests.
Main subject category:
Health Sciences
Keywords:
Microorganism, Control, pharmaceutical products
File:
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