An Overview of Medical Device Packaging Validation

Do you know why medical device packaging is so important? Usually proper packaging is required by the medical device is to avoid, physical damage, biological contamination, and any other external disturbance. The other motive is the proper identification of the device. The medical device packaging validations are mostly required for terminally sterilized medical devices. Because here the main goal is to keep the product sterile.

Types of packaging:

There are many kinds of packaging materials and methods are available. The material which comes direct contact with the medical devices are known as primary packing material and the material which comes contact with primary pack are called secondary packing this may be a paper/cardboard box. For the bulk storage and for transportation tertiary packing system can be used, this may be a carton box. Thus, the main goal of packaging validation is to confirm the material and method used for the primary packaging of the device, is suitable and yields the requirements of packaging. For example, the packaging material should be compatible with the sterilization process.  

The international standards for packaging validation recognized by EU regulation:

1. EN ISO 11607-1:2009 – Addressing packaging materials, sterile barrier system
2. EN ISO 11607-2:2006 – Addressing validation of packaging processes

MDR Requirements on Packaging Validation:

MDR annex I general safety and performance requirements (GSPR), specifies the packaging requirements of medical devices. The requirements can be summarised as;

1. The very first step is the Validation Plan

The validation process involves drafting of a validation plan, that shall contain the following.

Packaging equipment qualification is carried out by Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

Also, the quality properties shall checked through proper test methods, example : 

– intact seal

– no punctures or tears

– no open seals

– no material delamination

Then the sterile barrier system also checked, for this the packages which met all the above quality properties and correct packing are selected. This has been carried out by specific test methods.

The below quality properties must be verified and tested by suitable test methods.

– continuous closeness or the integrity

– no punctures or tears

– no other visible damage

– no material irregularities

3. Packaging Process validation Report:

Packaging process validation report shall document the following.

Process control and monitoring:

Routine test methods have to be developed to check the packaging quality. That is to avoid losing sterile barrier system and other requirements. Some of the test methods are listed.

Test Method:

Test methods are established to verify whether the quality properties are met.

1. Seal integrity test- done by Dye penetration, Bubble leak and visual checks.
2. Seal Strength testing- seal peel test, burst test
3. Seal integrity indicator
4. Visual Inspection

Process changes and re-validation: