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MEI630: PHARMACEUTICAL MATERIALS AND CONTAMINANTS (FORMERLY COM410)
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 are fully investigated in a timely fashion. This pharmaceutical contaminants course teaches an analytical approach that utilizes microscopical examination coupled with sample isolation, preparation, and analytical methods optimized for small particles, to successfully identify particulate contamination for regulatory compliance.
The overall analytical approach for the identification of particles (contaminants) 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), Raman Microscopy. The course emphasizes the identification of the following typical particle types: metals, minerals, fibers, hairs, glass, polymers, chemicals, excipients and botanicals.
In addition to using actual samples in the course, each student has access to the new online McCrone Atlas of Microscopic Particles. The Atlas contains PLM and SEM images, descriptions, and EDS, IR and Raman spectra from over 60 fully-characterized pharmaceutical contaminants.
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Are you interested in this course, but it is either not offered or not at a time that works with your schedule? Let us know and we will notify you when it is available next.
Offline registration is available by calling the registrar at 630-887-7100 or by downloading the offline registration form, completing it, and faxing to 630-887-7412.
* If a scheduled course is full, you may be placed in a waiting list.
- Stereomicroscopy
- Inspection and recording
- Sample preparation
- Polarized light microscopy
- Alignment
- Illumination
- Micrometry (sizing)
- Polarized light microscopy
- Morphology
- Plane polarized light and refractive index
- Spot, solubility and microchemical tests
- Polarized light microscopy
- Crossed polars
- Isotropic and anisotropic particles
- Birefringence and Michel-Lévy Interference Color Chart
- Compensation
- Infrared microspectroscopy (FTIR)
- Raman spectroscopy
- Method integration
- Methods and techniques for pharmaceutical contaminant identification
- Microscopical methods of materials analysis
- Stereomicroscopy and sample preparation using Olympus SZX10 stereomicroscopes
- Polarized light microscopy (using Olympus BX51 microscopes)
- Quality Control Scientists
- Chemists
- Pharmaceutical Scientists
- 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
- completed pre and post course assessment forms
Upon successfully meeting these requirements, a student is awarded a certificate of completion and IACET CEU credits, if available. Those who have not successfully passed the course requirements do not receive a certificate or IACET CEU credits.
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