بسته بندی ایمپلنت های ارتوپدی بر اساس استاندارد ISO 11607

نویسنده	امیرحسین گوهریان

The package barrier system is intended to be a physical barrier system to prevent penetration of any kinds of contamination (e.g. bacterial microorganism, organic carbon, or oil residues) to the internal space of the package. a

The functional requirements of the package are to keep the product safely against of surrounding environment. The package is to preserve cleanliness, sterility, and physical surface conditions of the product after production and during storage and transportation until using in the operation room. Furthermore, the package should be sealable to facilitate packaging of the implants after cleaning process. a

The package safety might be associated to its material to be compatible with the sterilization process. a

Objective. 4

Scope. 4

General requirements. 4

Packaging barrier system performance requirements. 4

Packaging barrier system functionality requirements. 4

Packaging barrier system safety requirements. 4

Associated risks. 4

Applicable standards. 4

Quality systems. 5

Sampling. 5

Testing methods for validation of package barrier system.. 5

Testing methods and associated standards. 5

Description of test methods. 6

Seal strength test 6

Dye penetration test 6

Accelerated test 6

Tensile properties. 7

Gas transmission rate. 7

Sterility test 7

Package compatibility with sterilization method. 7

Paper and board — Determination of tensile strength after immersion in water 8

Paper and board – Determination of air permeance. 8

Paper and board — Determination of tensile properties. 8

Validation parameters of test methods. 8

Suitability of the testing methods (Rationale for the selection of the appropriate tests for the packaging system) 9

Seal strength test 9

Dye penetration test 9

Accelerated test 9

Tensile properties. 10

Gas transmission rate for plastic film.. 10

Package material compatibility with sterilization method. 10

Paper and board — Determination of tensile strength after immersion in water 10

Paper and board – Determination of air permeance. 10

Paper and board — Determination of tensile properties. 10

Acceptance criteria. 10

Determination of test method repeatability. 11

Determination of test method reproducibility. 11

Materials and preformed sterile barrier systems. 11

General requirements. 11

Microbial barrier properties. 12

Compatibility with the sterilization and labeling processes. 12

Storage and transport 12

Design and development requirements for packaging systems. 13

Package design & performance. 14

Packaging design for sterile and non-sterile products. 14

Packaging procedure. 15

Qualification of the packaging equipment 15

Description of equipment and how it works. 15

Qualification of the sealing equipment 16

Package routine plan of validation testing. 16

Package routine control 17

بسته بندی ایمپلنت های ارتوپدی بر اساس استاندارد ISO 11607