Specific Requirements for the Manufacturing of Sterile Products, Parenteral Preparations, and Sterile Ophthalmic Preparations
About Course
Sterile products are highly sensitive and critical in nature, requiring meticulous precautions and preparations to ensure their safety and efficacy. This self-paced online course delves into the specific requirements for manufacturing sterile products, including small volume injectables, large volume parenterals, and sterile ophthalmic preparations. Participants will gain a deep understanding of the stringent standards and practices necessary for maintaining aseptic conditions in all manufacturing areas.
The course covers a wide range of topics, including building and civil works, air handling systems, environmental monitoring, garment requirements, sanitation procedures, and equipment specifications. Participants will learn about the critical role of water and steam systems in the manufacturing process, as well as the importance of containers, closures, and documentation in ensuring product quality.
Whether you are a pharmaceutical professional seeking to enhance your knowledge or a newcomer to the field, this course provides essential insights into the specialized requirements for manufacturing sterile pharmaceutical products. By the end of this course, you will have basic understanding of the regulations, practices, and infrastructure necessary for producing safe and effective sterile pharmaceuticals. Join us on this educational journey and elevate your expertise in sterile product manufacturing.
Course Content
1. Introduction
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Part 1 – Introduction
00:57
2. Building and Civil Works
3. Air Handling System (Central Air-Conditioning)
4. Environmental Monitoring
5. Garments
6. Sanitation
7. Equipment
8. Water and Steam Systems
9. Manufacturing Process
10. Form-Fill-Seal Technology or Blow, Fill-Seal Technology
11. Completion/finalization of sterile products
12. Product Containers and Closures
13. Documentation
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