Aseptic Usability Guidance | Maintaining Sterility to the End
This webinar reviews ISO 11607-1:2019 to stress the importance that a document usability evaluation shall be conducted and shall include an assessment of the ability to identify where to begin opening, the ability to recognize and perform the technique required to open the sterile barrier system, and the ability to subsequently present the contents aseptically. Additionally, the presenter concludes that the evaluation must be done under real or simulated conditions of use.
The webinar also briefly reviews best practices along with a case study from Packaging Compliance Labs.
- Regulations: ISO 11607-1 Section 7
- User Selection & Credentialing
- Study Design & Format
- Reporting Results