Design and Development Requirements for the ISO 11607-1 Packaging System

Materials and/or pre-formed sterile barrier systems shall be selected and validated with respect to performance evaluation in clause 5 of ISO11607-1.

The design and development of a packaging system shall include at least the following :

a.      User requirements and the use environment.

b.      Product quality and structure.

c.      Existing sharp edges or bumps.

d.      Needs for physical and other protection.

e.      Product’s sensitivity to specific risks (radiation, humidity, mechanism vibration, electrostatic discharge, etc.)

f.       The quantity of products in each packaging system.

g.      Packaging label requirements.

h.      Environmental limitations

i.       Product expiry date.

j.       Delivery and handling environments.

k.      Storage environment.

l.       Compatibility with sterilization and residues.

 

SBS Evaluation Characteristics

Design and Development Requirements for the ISO 11607-1 Packaging System