ISO 11607-01 - Questions Answered
With the recent publicaton of the new ISO 11607-01 standard, many medical device manufacturers and packaging professionals are uncertain of how the revised standard will impact the validation of their medical device packaging.
Following DDL's second Webinar in its series on the ISO 11607 Revisions, DDL received many questions from participants concerned with validating their packaging under the new standard.
Pressing questions include:
• Is it necessary to re-do previous validations to comply with the new standard?
• Is it compulsory to perform distribution simulation?
• Is it necessary to perform integrity testing after the different stages of handling
to qualify the package system?
Fill in the form below to receive the answers to packaging professionals' most pressing questions regarding ISO 11607-01.
Click here to listen to the ISO 11607 Revisions Podcast.
DDL is hosting the third and final Webinar in its ISO 11607 Revisions series - Implementing Clause 6 - on the following dates:
- August 15 at 10 am PST (12 pm CST; 1 pm EST)
- August 18 at 12 pm PST (2 pm CST; 3 pm EST)
- August 23 at 11 am PST (1 pm CST; 2 pm EST)
Don't worry if you missed the first two Webinars in this series, you can register here to listen to them both on-demand.
If you have an ISO 11607-01 related question, click here to have your question answered by an expert DDL package engineer.
Complete the form below to receive the ISO 11607 Revisions FAQ.
