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dc.rights.licenseAll rights reserveden_US
dc.contributor.advisorNieves Castro, Rafael A.
dc.contributor.authorSoto Echevarría, Yarelys
dc.date.accessioned2020-06-25T00:55:37Z
dc.date.available2020-06-25T00:55:37Z
dc.date.issued2018
dc.identifier.citationSoto Echevarría, Y. (2018) In-Process pharmaceutical manufacturing aqueous coating suspension hold time study [Unpublished manuscript]. Graduate School, Polytechnic University of Puerto Rico.en_US
dc.identifier.urihttp://hdl.handle.net/20.500.12475/204
dc.descriptionDesign Project Article for the Graduate Programs at Polytechnic University of Puerto Ricoen_US
dc.description.abstractA hold time study is established in the development phase of any product. All the InProcess unit operations require a hold time study to protect the integrity and quality of the final drug product. This study will analyze the hold time study of the collating suspension in a new product to be launched at the pharmaceutical site. The composition of the solution is 20% dye in 80% water. The samples were taken in duplicate to perform the microbiology test; Total Aerobic Microbial Count (TAMC), Total Yeast and Mold (TY&M) and E. coli presence. The solution was performed in 5 lots of equivalents components. The lots were executed on different days, rooms, equipment and operators. All the lots complied with the microbiology bioburden level. It can be established that a 72 hour hold time of color suspension preparation at GMP conditions is capable of reproducibly manufacturing product within predetermined quality attributes. Key Terms  Color Suspension, E.coli, GMP, Hold Time, TAMC, TY&M.en_US
dc.language.isoen_USen_US
dc.publisherPolytechnic University of Puerto Ricoen_US
dc.relation.ispartofManufacturing Competitiveness
dc.relation.ispartofseriesFall-2018
dc.relation.haspartSan Juan Campusen_US
dc.subject.lcshTime management
dc.subject.lcshEscherichia coli--Analysis
dc.subject.lcshAqueous polymeric coatings in pharmaceutical technology
dc.subject.lcshPolytechnic University of Puerto Rico--Graduate students--Research
dc.subject.lcshPolytechnic University of Puerto Rico--Graduate students--Posters
dc.titleIn-Process pharmaceutical manufacturing aqueous coating suspension hold time studyen_US
dc.typeArticleen_US
dc.rights.holderPolytechnic University of Puerto Rico, Graduate Schoolen_US


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