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April 30, 2025
Sterile Product Preparation Professional Certification
The Saudi Society of Clinical Pharmacy (SSCP) is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
Objectives:
- Implement cleanroom principles and practices that comply with USP 797 and 800 chapters and requirements.
- Ensure compliance with international and local standards.
- Instruct on the guideline for sterile product preparation and best practices in Intravenous admixture and parenteral nutrition.
- Ensures competency of all personnel involved in sterile compounding, validation, staff training and documentation.
- Develop a comprehensive understanding of the principles associated with workflow, cleaning, environmental sampling, validation, and documentation.
- Acquire mastery in engineering controls and air flow science.
Course Content
MoH-SSCP Sterile Product Preparation Program
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introduction
14:31 -
A) Introduction to Sterile Product Preparation
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The Art and science of IV fluid management and compounding
01:11:10 -
USP 797: Primary Engineering Controls (PEC) & Secondary Engineering Controls (SEC), air flow directions, concept of first air
01:01:27 -
Pharmacy Compounding Devices: Fluid Pumps, IV Workflow Systems and IV Robotics
48:41 -
Section Test 1
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B) Aseptic technique
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Consumables Required in the Clean Room
40:51 -
Rules of Clean Room and Personnel Responsibilities
33:46 -
Aseptic Technique and Manipulations
24:16 -
Cleaning and Disinfection (materials and process)
38:07 -
Section Test 2
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C) Material handling and preparation
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Proper Material Handling
15:19 -
Filters and Filtration
05:35 -
Initial Ingredient and Final Product Inspection
43:44 -
Assigning Risk Levels and Beyond Use Dating
52:25 -
Section Test 3
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D) Master Formulation and Labelling
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Master Formulation, Compounding Records, Safe Use of Compounded Sterile Preparations (BUD vs Stability vs Hang Time)
33:54 -
Sterility Testing of Compounding Sterile Preparations (for extension of Beyond Use Dates)
19:29 -
Labeling Requirements (main label and auxiliary label)
03:54 -
Pharmaceutical Calculation
01:38:58 -
Section Test 4
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E) Environmental control
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Cleaning and Maintenance of the Primary and Secondary Engineering Controls
38:07 -
Environmental Quality and Control, Personnel Monitoring (media-fill and fingertip testing)
55:30 -
USP 797 Updates: Changes to BUD, Environmental Testing, Personnel Training and Testing Requirements
28:57 -
Section Test 5
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F) Standards for safe handling and preparation of hazardous drug
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Overview of Chapter
29:53 -
Describe the NIOSH-defined characteristics of a hazardous drug
16:35 -
Describe the importance for an entity to perform an Assessment of Risk for all hazardous
39:30 -
Safe handling and disposal of Hazardous medications
45:10 -
Section Test 6
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Final Exam