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SMP505: SAMPLE PREPARATION: PHARMACEUTICAL AND MEDICAL DEVICES (FORMERLY COM310)
Taught by members of cleanroom staff at McCrone Associates, specialized techniques are demonstrated for isolating and mounting contaminants from pharmaceutical and medical devices. Students use an Olympus SZX10 stereomicroscope. More than 50% of class time is spent practicing the techniques. Topics related to these techniques may include but are not limited to, tablets, contact lenses, and contaminants/foreign materials.
This 2-day practical course is customized to meet the needs of each individual student. A maximum class size of 10 students allows the instructor(s) to provide individual attention. Prior to the course, each enrolled student is asked to fill out a questionnaire to ensure their individual needs are met. Students are also encouraged to bring samples with them to the class.
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 100 fully-characterized microscopic materials.
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No sessions currently scheduled for this course.
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
- Overview
- Lighting techniques including: coaxial and oblique illumination
- "The Microscopist Bench" Tools and Supplies
- Proper handling of tools and samples including; needles, blades, micro-pipettes, micro-coverslips, glass rods
- How to use micro volumes of solvents
- Preparing Particles on Substrates for Analysis
- Salt plates (KBr)
- Carbon planchet
- Beryllium
- TEM grids
- Silicon wafers
- E-glass slide
- Well slide
- Filtration Methods
- Glass apparatus
- Choice of filter (PC, PE, MCE)
- Direct vs. pooling
- Isolation Methods
- Liquids
- Solids
- On surfaces
- Specific examples
- Glass delamination
- Tablet defect
- Medical device contaminant
- Dark specks in powders
- Identification of haze in Parenterals
- Identification of contaminants in Parenterals
- Hands-on techniques using provided samples and student samples
- Techniques for isolating contaminants and foreign material from pharmaceuticals and medical devices for analysis
- Proper handling of microtools
- Basic Stereomicroscopy using Olympus SZX10
- Students are strongly encouraged to bring their own samples, related to their job, to learn how to isolate, mount, and manipulate them
- Pharmaceutical technicians/scientists
- Quality control technicians/scientists
- Cleanroom personnel
- Professionals who must prepare, isolate, mount, or manipulate samples relevant to pharmaceuticals and medical devices
- Detailed course manual
- SZX10 stereomicroscopes for each student
- Students should be familiar with light microscopy and stereomicroscopy.
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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