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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;

  • The device shall package in a way that its characteristics and performance should not adversely affect during transport and storage.
  • The device shall package in such a way as to minimize the risk posed by contaminants and residues to patients.
  • The package shall ensure that retain the sterile condition, till the pack is broken.
  • Packaging systems for non-sterile devices shall maintain the integrity and cleanliness of the product.

How to conduct Packaging Process Validation ?

  1. The very first step is the Validation Plan

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

  • responsibilities,
  • description of the materials
  • description of equipment
  • how the packaging process going to carry out
  • Description of sterilization process

2. Second is Implementation of validation

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

  • Installation Qualification (IQ)– The equipment is checked for the proper installation according with the specification. 
  • Operational Qualification (OQ)– check whether the equipment work within the pre-limited parameters. Like the sealing temperature, speed contact pressure.

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.

  • Performance Qualification (PQ)– it is performed during normal operation in accordance with predetermined criteria. Usually proof must be given after sterilization that the process is under control and produces optimally sealed and sterile barrier system. This verification is done by seal strength test.

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.

  • The evidences of packaging process validation (result of IQ, OQ and PQ).
  • The results shall be evaluated
  • Formal approval of validation
  • Process Control and monitoring
  • Process changes and re-validation

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:

  • Schedule re-validation at regular intervals, eg. every year, if there is no change in material, sealing process or sterilization.
  • Provide evidence that the packaging process are in line with initially validated parameters.
  • If there is any change in process, material or sterilization then record how this change will affect the packaging process, and according to with this result, individual re-validation plan must be made. For example, OQ, PQ must be partially or fully repeated.  

Reference: EN ISO 11607, EU MDR


4 Replies to “An Overview of Medical Device Packaging Validation”

  1. Pingback: Risk Analysis

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