IMPLEMENTATION OF REAL TIME RELEASE TESTING ON DOXYCYCLINE CAPSULE MIXING PROCESS IN PT. PQR
Along with technology development in pharmaceutical industry, currently process of quality product measurement has been develop into real time measurement during the process or Real Time Release Testing (RTRT) using Process Analytical Technology (PAT) tools that is near infrared spectroscopy. Thi...
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| 格式: | Theses |
| 語言: | Indonesia |
| 在線閱讀: | https://digilib.itb.ac.id/gdl/view/56612 |
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| 機構: | Institut Teknologi Bandung |
| 語言: | Indonesia |
| 總結: | Along with technology development in pharmaceutical industry, currently process
of quality product measurement has been develop into real time measurement
during the process or Real Time Release Testing (RTRT) using Process Analytical
Technology (PAT) tools that is near infrared spectroscopy. This study aims to
implement Real Time Release Testing (RTRT) to replace conventional quality
product measurement with sampling along the process and followed by offline
measurement. In this study, mixing process of Doxycycline Capsule was carried out
and conducted in-line measurement of Critical Quality Attribute (CQA) i.e. blend
homogeneity using near infrared spectroscopy. Then, proceed with capsule filling
process and samples were taken to measure content uniformity of the product using
HPLC (High Pressure Liquid Chromatography) method. Based on the research,
the mixing of Doxycycline capsules with number of revolutions of 100 and speed of
11 rpm (revolutions per minute) was scanned and processed data spectrum using
Moving Block Model (MBM) with F-test statistical analysis, the result was F value
below the critical F value which was in the state of homogeneous condition. After
filling process, the results of content uniformity using HPLC (High Pressure Liquid
Chromatography) method showed that Relative Standard Deviation value for each
sampling interval below 5.00%, the value of each individual sample fall between
90.00 - 120.00%, and the L1 value is less than 15.0. The results of capability
analysis process provide value of centering capability index (Cpk) 1.63 and
performance centering index (Ppk) 1.62, which indicates that the process of inter
and intra batch are satisfactory, reliable, and consistent. Based on the research
results, the real-time release testing process of the Doxycycline Capsule mixing
process can be applied at PT. PQR.
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