ISO11607-2 (Validation requirements for forming, sealing and assembly processes), requires Operational Qualification (OQ) of packaging devices to be carried out and documented.
The OQ is requiring providing proof of:
- Intact seal for a specific seal width
- No channels or open seals
- No punctures or tears in seals
- No material delaminating or separation
The OQ needs to be carried out on a daily basis to release the packaging device before use. For this purpose Famos offers two different seal tests: