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6. Flexel ® <strong>3D</strong> <strong>Bag</strong> 7. Shelf Life of a 8. Product Complaint<br />
Storage Conditions Flexel ® <strong>3D</strong> <strong>Bag</strong><br />
Flexel ® <strong>3D</strong> <strong>Bag</strong>s can be stored in their original<br />
primary packaging at room temperature<br />
(5°C to 40°C), in a dry environment.<br />
6<br />
The shelf life after gamma sterilisation has<br />
been validated as indicated on the labelling<br />
(product packaging and case) and in the<br />
specifications. Details are available from <strong>Sartorius</strong><br />
Stedim Biotech upon request.<br />
When may a complaint occur?<br />
When a malfunction or deterioration in<br />
the characteristics and/or performance of<br />
a marketed product as well as any inadequacy<br />
in the labelling, instructions for<br />
use, release certificate and/or customer<br />
services have occurred.<br />
To whom should the complaint be sent?<br />
To your <strong>Sartorius</strong> Stedim Biotech commercial<br />
contact person or distributor.<br />
How and which information should be<br />
conveyed?<br />
A complaint form is available at<br />
http://www.sartorius-stedim.com and<br />
should be sent by e-mail, fax or letter<br />
with:<br />
– the defect description;<br />
– the description of the process in which<br />
the defect was detected;<br />
– the bag or bag system traceability (product<br />
code & lot number).<br />
The bag or device deemed defective is<br />
required to perform the investigation.
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