In-Process pharmaceutical manufacturing aqueous coating suspension hold time study
Soto Echevarría, Yarelys
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A 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.