Pharmaceutical Materials and Contaminants
Most pharmaceutical products are specified to be essentially free of visible particles, and there are limits on the number of allowable sub-visible particles. The FDA requires that contamination problems be fully investigated in a timely fashion. Utilizing microscopical examination coupled with sample isolation, preparation, and analytical methods optimized for small particles, this pharmaceutical analysis course teaches an analytical approach to successfully identify particulate contamination for regulatory compliance.
The overall analytical approach for the identification of contaminant particles is outlined at the beginning of the course. The analysis plan includes sample examination, gathering of background information concerning the sample, and particle isolation. Analytical methods taught include: stereomicroscopy, polarized light microscopy (PLM), Fourier transform infrared spectroscopy (FTIR), and Raman. The course emphasizes pharmaceutical microscopy to identify the following typical particle types: metals, minerals, fibers, hairs, glass, polymers, chemicals, excipients, and botanicals.
In addition to using actual samples in this pharmaceutical analysis course, each student has access to the free online McCrone Atlas of Microscopic Particles. The Atlas contains PLM and SEM images, descriptions, and EDS, IR, and Raman spectra for more than 60 fully-characterized pharmaceutical contaminants.
- Inspection and recording
- Sample preparation
- Polarized light microscopy (ordinary light)
- Micrometry (sizing)
- Spot, solubility, and microchemical tests
- Polarized light microscopy (plane polarized light)
- Refractive index
- Polarized light microscopy (crossed polarizers)
- Crossed polarizers
- Isotropic and anisotropic particles
- Birefringence and Michel-Lévy interference color chart
- Extinction type
- Optic sign
- Sign of elongation
- Infrared microspectroscopy (FTIR)
- Raman spectroscopy
- Method integration
- Methods and techniques for pharmaceutical contaminant identification
- Microscopical methods of materials analysis
- Stereomicroscopy and sample preparation
- Polarized light microscopy
- Quality control scientists
- Pharmaceutical scientists
All instrumentation, materials, and supplies necessary for successful completion of this course will be provided onsite by Hooke College of Applied Sciences.
- Detailed course manual
- Olympus BX51 microscope for each student
- SZX10 stereomicroscopes for each student
- Familiarity with pharmaceutical materials
- Vendor or in-house training in use of polarizing microscope and infrared spectroscopy
Students are expected to successfully complete a variety of tasks in the form of hands-on exercises, laboratory exercises, identifications of unknowns, and quizzes. In addition, the students are required to have 100% attendance during the course, participate in class, complete a student evaluation form and pre- and post-course assessment forms.
The student is notified at the end of the course whether or not they have successfully completed the requirements of the course based on:
- 100% Attendance
- Class participation
- Completion of all course material
- Completed and signed student evaluation form
Upon successfully meeting these requirements, a student is awarded a certificate of completion and CEU credits, if available. Those who have not successfully passed the course requirements do not receive a certificate or CEU credits.