Specific Requirements for the Manufacturing of Sterile Products, Parenteral Preparations, and Sterile Ophthalmic Preparations

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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.

 

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What Will You Learn?

  • Building and Civil Works
  • Air Handling System (Central Air-Conditioning)
  • Environmental Monitoring
  • Garments
  • Sanitation
  • Equipment
  • Water and Steam Systems
  • Manufacturing Process
  • Form-Fill-Seal Technology or Blow, Fill-Seal Technology
  • Completion/finalization of sterile products
  • Product Containers and Closures
  • Documentation

Course Content

1. Introduction

  • 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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