Flexel ® 3D Bag Storage Conditions; Shelf Life Of A Flexel ® 3D Bag; Product Complaint - Sartorius Stedim Biotech FLEXEL 3D-Beutel Benutzerhandbuch

6. Flexel ® 3D Bag
Storage Conditions
®
Flexel 3D Bags can be stored in their origi-
nal primary packaging at room temperature
(5°C to 40°C), in a dry environment.
6
7. Shelf Life of a Flexel
The shelf life after gamma sterilization has
been validated as indicated on the labeling
(product packaging and case) and in the
specifications. Details are available from
Sartorius Stedim Biotech upon request.
® 3D Bag

8. Product Complaint

When may a complaint occur?
When a malfunction or deterioration in
the characteristics and|or performance of
a marketed product as well as any inade-
quacy in the labeling, instructions for
use, release certificate and|or customer
services have occurred.
To whom should the complaint be sent?
To your Sartorius Stedim Biotech com-
mercial contact person or distributor.
How and which information should be
conveyed?
A complaint form is available at
http://www.sartorius-stedim.com and
should be sent by e-mail, fax or letter
with:
- the defect description;
- the description of the process in which
the defect was detected;
- the bag or bag system traceability
(product code & lot number).
The bag or device deemed defective is
required to perform the investigation.