Sartorius Stedim Biotech Flexsafe 3D Bag For Palletank Benutzerhandbuch Seite 14

7. Shelf Life of a Flexsafe 3D Bag
®
The shelf life after gamma sterilization has been validated as indicated on the
labelling (product packaging and case) and in the specifications. Details are available
from Sartorius Stedim Biotech upon request.
8. Product Complaint
When is a complaint justified?
When a deficiency related to the safety, quality, identity or purity or a deficiency in
providing a service is identified on a marketed product.
To whom should the complaint be sent?
To your Sartorius Stedim Biotech commercial contact or distributor.
How and which information should be conveyed?
A complaint form will be provided by your Sartorius Stedim Biotech commercial
contact and should be returned by e-mail, fax or letter with the following
information:
− the bag or bag system product part number and lot number
− the description of the issue
− the description of the process in which the issue was detected
− the amount of products affected
− samples (or pictures if no samples are available)
If samples are returned, they must be empty, rinsed and decontaminated
(if applicable). They must be returned with the signed the Health and Safety part
of the complaint form.
14 Shelf Life of a Flexsafe ® 3D Bag | Product Complaint