ISO 11607 Training
Our training program covers ISO 11607, which sets out rules and testing methods for packaging medical devices that have been sterilized. It ensures the packaging works for sterilization, protects the device, keeps it sterile until you use it, and is safe for the materials. Following this standard is really important to make sure the device is safe, works well, and meets regulations.
At the end of the program participants should be able to do the following:
Understand the philosophy and principles of sterile barrier systems and packaging systems.
Aware of validation and routine control of the sterile barrier systems and packaging systems method and requirement.
Understand the key factors for sterilization process development.
Set the State- Overview:
• Ice breaker- “Recognizing and Identifying STERILE Product
• Objectives of the workshop
• Administrative arrangement
Session 1: Overview of Sterile Barrier Systems and Packaging Systems
• Representative’s types of sterile barrier systems and packaging systems
• Packaging verification
Session 2: Key Factors of Sterile Barrier Systems and Packaging Systems Process Development
• Packaging process validation
• Awareness of ISO 11607-1 and ISO 11607-2