PFT505 - Fundamentals of Physical Testing

Subject Title
Fundamentals of Physical Testing

Subject Description
This subject provides a theoretical and practical study of some of the most commonly used, but critical physical testings in the pharmaceutical industry of solid, semi-solid and liquid dosage forms. Such testing is mandatory as per regulations and critical from a quality point of view and includes in-process testing of bulk product, finished product and raw-material. in recent years, testing also focused on pre-formulation studies and physical characterization of pharmaceutical active ingredients. Students practice using instruments such as a microscope, particle size analyzer, viscometer, moisture analyzer and various tabletting in-process test instruments including disintegration tester, hardness tester and friability tester. Students gain theoretical knowledge of x-ray diffraction, particle size analysis by laser defraction and differential scanning calorometry (DSC). Students also learn about applying these various techniques for analytical and formulation purposes. (Lecture and Labs)

Credit Status
One credit towards the Pharmaceutical Instrumentation Analyst (PIA) Certificate Program

Learning Outcomes
Upon successful completion of this subject the student will be able to:

1. Demonstrate basic understanding of a variety of physical characterization techniques used in pharmaceutical industry in analytical and formulation areas.

2. Apply the principles of physical testing for an understanding of drug physical properties.

3. Identify various physical testing to be performed on a drug from regulatory and quality point of view.

4. Assess the physical properties of bulk product, finished product and raw material for quality assurance and release purposes.

5. Prepare method development and validation protocols for physical testing.

6. Analyze and interpret the results of various physical testing obtained from an outside lab to support in process release testing, pre-formulation and stability studies etc.

7. Use basic laboratory equipment to characterize basic physical properties of solid, semi-solid and liquid dosage forms.

Academic Integrity
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Please visit the Academic Integrity website http://open2.senecac.on.ca/sites/academic-integrity/for-students to understand and learn more about how to prepare and submit work so that it supports academic integrity, and to avoid academic misconduct.

Discrimination/Harassment
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Accommodation for Students with Disabilities
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Camera Use and Recordings - Synchronous (Live) Classes
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