Follow Us:

EU & US FDA

Home Medical Device Packaging
Quick Contact
MDR Technical Documentation Support

Find how we can be helpful for your team

Medical Device Packaging

Medical Device Packaging is an important factor to place the device in the market safe and secured during the shelf life. Packaging performs protection and communication with the environment, humans, and vice versa.

 

For a medical device, protection is necessary by maintaining package integrity, 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 by means of labeling.

Types of Packaging

There are many kinds of packaging materials and methods available. The material which comes in direct contact with the medical devices is known as primary packing material and the material which comes contact with the primary pack is 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, which is suitable and yields the requirements of packaging.

 

For example, the packaging material should be compatible with the sterilization process.

Packaging and MDR Requirements

MDR annex I general safety and performance requirements (GSPR), specifies the packaging requirements of medical devices. The requirements can be summarized 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.
  • Test

EU and FDA Standards

  • EN ISO 11607-1 Addressing packaging materials, sterile barrier system
  • EN ISO 11607-2 Addressing validation of packaging processes
  • BS EN 868-2 Packaging for terminally sterilized medical devices. Sterilization wrap. Requirements and test methods
  • ASTM D3330 Package Strength Testing by Peel Adhesion Testing
  • ASTM F88 Package Strength Testing by Seal Peel Testing
  • ASTM F1140 Package Strength Testing by Burst Testing
  • ASTM F2054 Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates
  • Package Integrity (ASTM F2096: Bubble Test)
  • Seal Integrity (ASTM F1886: Visual Inspection, ASTM 1929: Dye Test)
  • Seal Strength (ASTM F88: Peel Test, ASTM F1140: Burst Test)

Packaging Process Validation
(a) Validation Plan

for terminally sterilized medical devices , the validation process involves creating 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

(b) 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 prelimited parameters. Like the sealing temperature, speed contact pressure.

Also, the quality properties shall check 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

(c) 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 revalidation

Packaging Requirements for non-sterile medical devices:

Literally there is no specific standard to follow for the packaging validation of non-sterile medical devices. However, the manufacturer must fulfil the requirement of GSPR. Thus, it is up to the manufacturer to select appropriate packaging for there medical device, and it should not be harmful to the function and efficiency of the device. The package must be sufficient to protect the device, for example if drop will damage your device, then the package must be sufficiently padded/cushioning form to protect the device damage from dropping.

GSPR requirement:

  • The device shall package in a way that its characteristics and performance should not adversely affect during transport and storage.
  • Packaging systems for non-sterile devices shall maintain the integrity and cleanliness of the product.

 

The manufacturer must have to demonstrate to meet the above requirements. And its all up to them how to demonstrate. Some methods we can suggest the following.

 

  • Perform suitable test depends on the risk assessment like drop test, vibration test etc to demonstrate to meet the devices characteristics and performance is not adversely affect during transport and storage.
  • Stability test, by accelerated or real time method.
  • Consider packaging solutions adapted by similar/equivalent device in the market
  • Package the device and send it out with standard couriers to most unsure locations and get it back.

Benefits of conducting Packaging Validation:

  • Packaging validation helps to ensure that the device is met the requirements of packaging needs and regulation requirements. Eg. Ensure the sterility of device.
  • Validation helps the manufacturer to select the optimal packing material and there by cost effective.

Buy Risk Analysis Procedure & Templates

Very useful for small and medium size medical device manufactures