PARTICLE ANALYSIS AND PREVENTION PLAN IN QUALITY ASSURANCE PROCESS OF OMEPRAZOLE FREEZE DRIED POWDER IN FACTORY X
The visible particulate parameter is one of the quality aspects for injection products. Factory X has a problem regarding visible particles found in freeze dried Omeprazole powder made using the lyophilization process in a tray but not found in the lyophilization process in vials. Isolation of pa...
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Main Author: | |
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Format: | Theses |
Language: | Indonesia |
Online Access: | https://digilib.itb.ac.id/gdl/view/44032 |
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Institution: | Institut Teknologi Bandung |
Language: | Indonesia |
Summary: | The visible particulate parameter is one of the quality aspects for injection
products. Factory X has a problem regarding visible particles found in freeze
dried Omeprazole powder made using the lyophilization process in a tray but not
found in the lyophilization process in vials. Isolation of particles is carried out by
filtering the reconstituted product using a 0.45 micron filter under Laminar Air
Flow (LAF). Characterization of particles is carried out using particle
identification paths listed on PDA TR 78. Based on testing using the Fourier
Transform Infra Red (FTIR) spectrophotometer, the similarity with mannitol with
a purity index of 0.9112 and 0.8446 towards omeprazole was obtained. Tests
using X-Ray Difraction (XRD) showed a similarity with mannitol hemihydrate.
Tests using the Scanning Electrone Microscope (SEM) show the particles look
solid and there are no cavities that can help solubility. Based on the risk analysis
carried out, the method / process aspect has a critical role in the formation of
particles. The slow cooling rate causes the uneven cooling process and the
formation of mannitol hydrate is thought to be a factor causing the formation of
particles. The proposed strategy for handling visible particulates is a controlled
nucleation process when freezing before annealing, preventing the formation of
mannitol hemihydrate through the addition of sodium chloride into the formula to
inhibit the crystallization process during the cooling process so as to prevent the
appearance of mannitol hydrate, addition of annealing process with prolonged
time, removal of mannitol hydrate through the secondary drying process with
temperatures> 40 ° C and a vacuum pressure close to 0.000 mbar, and also
change mannitol with other bulking agent. Another possible root cause is the
interaction between omeprazole sodium with mannitol, but it was not explored in
this final project.
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