Flexel
®
3D bags can be stored in their origi-
nal primary packaging at room temperature
(5°C to 40°C), in a dry environment.
The shelf life after gamma sterilisation 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.
When is a complaint justified?
When a malfunction or deterioration in
the characteristics and/or performance of
a marketed product has occurred or any
inadequacy in the labelling, instructions
for use, release certificate and/or cus-
tomer services is found.
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 following:
- description of the defect;
- description of the process in which the
defect was detected;
- the bag or bag system traceability infor-
mation (product code & lot number).
The bag or device deemed defective is
required in order for our specialists to
investigate the complaint.
6
6. Flexel
®
3D Bag
7. Shelf Life of a Flexel
®
3D Bag
8. Product Complaint
Storage Conditions
