This USP <788> course covers the United States Pharmacopeia National Formulary Method <788> Particulate Matter in Injections, Microscopic Particle Count Test. This one-day course provides students with a hands-on understanding of the Microscopic Particle Count Test portion in the method as well as instruction on how to prepare samples for counting, and performing microscopic particle counts. This course is taught by members of the cleanroom staff at McCrone Associates who have analyzed a wide variety of pharmaceutical products by USP <788> method, students benefit from years of instructor experience.
USP <788> Particulate Matter in Injections
- Overview of USP <788> Method Particulate Matter in Injections
- Microscopic Particle Count Test
- Filtration setup
- Obtaining a blank
- Sample Filtration
- Mechanical and optical alignment of a microscope
- Particle counting
- Data interpretation
- Given an interpretation of USP <788> Microscopic Particle Count Test, Method 2, along with understanding proper filtration and microscope set up, the student will perform their own filtrations and particle count tests and learn to interpret the results
- Given an interpretation of USP <788>, Method 2, the student will understand the testing environment, the best time to use the test method, and the defined parameters
- Given a demonstration of proper filtration set up, the student will prepare blanks and a real-time sample set
- Given an overview of proper microscope set up, the student will understand equipment requirements and perform particle count tests
- Instructed in how to count particulate filtered, the students will learn to calculate counts to interpret results
- Pharmaceutical scientists
- Pharmaceutical laboratory technicians
- Detailed course manual
- Olympus BX51 polarized light microscope for use by each student
“I want to thank you once again. In all of the training I have attended (including the aerospace industry) I feel the course you presented yesterday is at the top of the list. I have already incorporated some changes to my protocol which will ultimately improve our test method and be more efficient.” Baxa Corporation
- Familiarity using a microscope
- Exposure to USP <788> method
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.
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