This webinar in designed to provide the basic knowledge needed to create and operate a sterile manufacturing facility.
The manufacture of sterile medical products and medications requires all of the things demanded of non-sterile manufacturing plus a long list of additional procedures, techniques, and specialized facilities required to assure the enhanced cleanliness and sterility that is required of these very special products. A detailed treatment of this subject would take two or three days. To meet the time constraints of this presentation, we will limit the discussion to clean room design and operation - the basic concepts of sterile operation.
The manufacture of sterile medical products and medications requires all of the things demanded of non-sterile manufacturing plus a long list of additional procedures, techniques, and specialized facilities required to assure the enhanced cleanliness and sterility that is required of these very special products. A detailed treatment of this subject would take two or three days. To meet the time constraints of this presentation, we will limit the discussion to clean room design and operation - the basic concepts of sterile operation.
Areas Covered in the seminar:
- Clean Room design - materials of construction; air locks. Air showers, material flow, people movement, and air flow.
- Containment.
- Gowning.
- Sterile Procedure.
- Process control.
- Environmental control and monitoring.
- Assurance of sterility.
- Diofference between pharmaceutical & electronics.
Who Will Benefit:
This webinar in designed to provide the basic knowledge needed to create and operate a sterile manufacturing facility.- Managers
- Supervisors
- Leaders
- Operators
- QA inspectors
- Scientists
- Auditors and researchers wor work in manufacturing
- Quality assurance/quality control
- Regulatory
- Research and development in the pharmaceutical and biologics industries as well as similar workers involved in the medical device and diagnostics industries.
Course Provider
James Harris(PhD),
