UL Webinar - Packaging Testing For Medical Devices

PACKAGING TESTING FOR
MEDICAL DEVICES
ISTA 2 A and ISO 11607 Requirement
UL and the UL logo are trademarks of UL LLC © 2017. Proprietary & Confidential.
AGENDA
• Introduction
• Regulations / Standard Requirement
• Brief on ISTA 2 A (International Safe Transit Association)
• Package Integrity Test .
• Combined stability and packaging validation
• UL India Services
2
INTRODUCTION
• Medical Device Packaging is highly regulated and must meet regulatory

requirement.
• Packaging must comply with ISO 11607 in order to satisfy European
regulations and obtain a CE Mark.
• Fulfilling ISO 11607, ensures physical protection and maintains sterility up
to the point of use.
• Packaging testing is measuring the characteristics and property of
packing material
• Most precarious factor is the sterility which should be maintained through
the distribution and storage.
• Testing a new packaging design before full scale manufacturing can save
time and money
3
INTRODUCTION
Packages are tested, when?
New Design Design Change Material Change
• Many manufacture conduct packaging testing in-house or through third

party lab (ISO/IEC 17025 accredited)
• Testing and validation should be in compliance to ISO 11607-1 and
designed to meet the compliance with FDA, ISO, EN and CE mark
requirements.
• Package Validation Testing is vital to ensure integrity of the package's seal
4
SIMULATION OF LIFE CYCLE OF A MEDICAL DEVICE?
TYPICAL LIFE CYCLE
Transport
Manufacturing and
Packaging Sterilisation
Final consumption Transport

as final MP
Storage
5
MEDICAL DEVICE STABILITY
Factors influence the medical device product stability:

• General Factors
• Chemical
• Physical
• Microbiological
• Toxicological Considerations/ Biocompatibility
6
PACKAGING TESTING - WHEN?
Packaging testing can be done at many stages of the product cycle:

• Prior to new product launch,
• With new packaging redesigns,
• When product damage is an issue in your company,
• When your clients require testing.
The best way to prepare is to include testing as early in the packaging design
as possible
7
ADVANTAGES OF PACKAGING TESTING
• Protect the Product

• Save Money. Each Time Your Product is Damaged During Shipping, You
Lose Money
• Increase Brand Loyalty
• Reduce the Need for Trial Shipments
• Reduce Product Claim Headaches
8
REGULATIONS AND STANDARDS
ISO 11607 address sterile barrier systems and packaging system intended to
be maintain sterilized until the point of use
Part 1
covers the requirements for materials, Sterile barrier systems and
packing systems mainly for manufacturer
Part 2
covers packing for terminally sterilized medical devices, validation
requirements for forming, sealing and assembly processes
Definition of sterile barrier systems as per ISO11607-2

Minimum package (e.g. pouch or wrapping) that prevents ingress of
microorganisms and allows aseptic presentation of the medical product at the
point of use
9
REGULATIONS AND STANDARDS
Package validation Testing
Package Integrity Distribution Stability Testing

Testing Simulation Testing
Test Procedures: Test Procedures: Test Procedures:

•Seal Integrity • Atmospheric Conditioning • Accelerated Aging
 Visual Inspection (ASTM D4332) (ASTM F1980)
(ASTM F1886) • Drop Test (ASTM D5276)
 Dye penetration • Vibration Test (ASTM
(ASTM F1929) D4728)
•Seal Strength • Compression Test (ASTM
Peel Test (ASTM F88) D642)
Burst test (ASTM F1140) • Low Pressure (ASTM
Bubble Test (ASTM D6653)
F2096)
•Microbial Challenge
ASTM F 1608 ISO 11607-1: Require both accelerated and real time
to be performed simultaneously
The key areas to be focused in the packaging areas are stability, package
integrity, performance and strength testing.
10
ISTA 2 A (INTERNATIONAL SAFE TRANSIT
ASSOCIATION)
ISTA 2 A is for Packaged-Products 150 lb (68 kg) or Less
ISTA 2 Series tests are a combination of basic test elements from ISTA 1
Series (Non-Simulation Integrity Performance Testing) and advanced test
elements from ISTA 3 Series (General Simulation Performance Testing).
• They challenge the capability of the package and product to withstand
transport hazards, but
• They only simulate some actual transport hazards, and
• They do not necessarily comply with carrier packaging regulations.
When properly applied, ISTA procedures will provide tangible benefits of:
• Shortened packaged development time and confidence in product launch
• Protection of products and profits with reduced damage and product loss
• Economically balanced distribution costs
• Customer satisfaction and continued business.
11
BEFORE YOU BEGIN ISTA 2 A
12
OVERVIEW OF ISTA 2A TEST SEQUENCE
13
TRANSPORT SIMULATION: ISTA 2 A: 2011
(ATMOSPHERIC CONDITION)
14
COMPRESSION TEST
15
DISTRIBUTION SIMULATION TESTING
TRANSPORT VALIDATION
Compression Test ASTM D 642
Implementation of Compression Test (stack test), eg. Apply-and-hold method.

Simulation of the lowest package in the stack:
The test load is applied uniformly over an hour on the container to be tested.
16
RESULTS OF TESTS
Compression Test
Rating: results in product damage,
high risk
Avoidance: More stable adhesive
tapes, cardboard stronger, eventually
filling material or deposits
17
VIBRATION TEST
Fixed displacement Vibration:
Calculate the test duration after the frequency required to bounce the packaged product is determined in the vibration test.
Random Vibration:
Overall Grm s level of 1.15. The theoretical stroke required to run this vibration profile is 22.45 mm (0.884in) peak to peak.
18
Drop Test Random Vibration Test
Drop (ASTM D 5487) Random Vibration Test (ASTM D 4728)

• one drop on a base corner, on each • To simulate real world environments.
edge radiating from that corner, and • Random testing can be used to
one on each flat face of package; a duplicate transportation, seismic and
total of 10 impacts. operating vibrations.
• Material placed on table moved at
25mm displacement in linear or
circular motion
Most labs does not specify the corner of the impact or number of drops required
19
DROP TEST
20
RESULTS OF TESTS
SPONSOR
Result of Drop Test Result of Vibration

Rating: mostly cosmetic problem Rating: mostly cosmetic problem
Avoidance: corners reinforce from the Avoidance: only about Pallet Delivery
inside
21
PACKAGE INTEGRITY TEST
• To ensure the integrity of the package seal and packaging system

• Validation will provide assurance and security that a package is sealed
properly, leak-free, and secure from any number of outside contaminants.
Integrity testing includes

• Visual Inspection
• Peel strength
• Burst test
• Bubble emission test
22
SEALING PROCESS EXAMINATION
Visual Appearance :
• Inspection of the sealed seams for defects
• Determination of the minimum seal width
Observation
• no damage
• same sealing seam width around the pack
• no wrinkles at the film or paper
• cutting edges around the laminate are clean
• no dirt or foreign matter in the paper and film
23
VISUAL INSPECTION
Deformation Break / crack and / or
Irregular Tyvek /
or further damage deformation of the
Blister fixation
of the Box blister surface
24
SEALING PROCESS- EXAMINATION
Burst Test (ASTM Dye Penetration Bubble Test (ASTM

F2054) (ASTM F1929) F2096)
• Determine the burst • Introducing a dye • Submerging the

pressure using solution having a package in a water
boundary plates detergent to the bath and inflating
• Documentation of inside of the with air pressure
the failure point package • Observation of the
• Leak testing of air flow from the
sealed seams over deep-drawing tray
a defined period • Note: the deep-
each seal portion drawing tray must
be sealed with a film
for this test
25
INTEGRITY TEST - DYE TEST
• No sealing failures (channels or holes at the sealing seam)

• Can be tested by sealing seam integrity test (blue colored test liquid)
No channel = sealing seam is integral channel = sealing seam is not integral
26
DYE TEST - INTERPRETATION AND DAMAGE
PATTERN
1 Tunnel like Incomplete Penetration 2 Channel like incomplete Penetration
27
PEEL TEST
Seal Separation Modes
Adhesive Cohesive Delamination
Interferences
Break Break (remote) Elongation Peel with elongation
28
AIR PERMEANCE TEST
• Test using the following standard:

• ISO 5636-5: “Paper and board - Determination of air permeance and
air resistance (medium range) - Part 5: Gurley method”
• Test method is mentioned explicit in ISO 11607-1 as resistance test of
impermeable materials to the passage of air
• Method can also be used for air permeable materials
• Verification of possible impacts of the packaging material due to degassing
of substances, printings, transport and storage stress
29
MICROBIAL BARRIER TESTS
• Test using the following standard:

• DIN 58953-6 „ Sterilization - Sterile supply - Part 6: Microbial barrier
testing of packaging materials for medical devices which are to be
sterilized”
• Chapter 3: Germproofness test at wet conditions
• Chapter 4: Germproofness test using an air steam
• Detection of germ permeance of air permeable packaging materials (e.g.
Tyvek, paper)
30
COMBINED STABILITY AND PACKAGING
VALIDATION ACCORDING TO ISO 11607-1
• Simulation of a medical device life cycle

• Planning of a combined stability study
31
SIMULATION OF A MEDICAL DEVICE LIFE CYCLE
ACCELERATED AGING ACCORDING TO ASTM F 1980
Background o ISO 11607-1 requires: The stability test must be carried out using real time aging.
o BUT: The stability test using reports on accelerated aging shall be regarded as sufficient evidence
for the expiry date required until data from studies on real time aging are available.
Accelerated
Beschleunigte Aging
Alterung
ASTM F1980: Standard Guide for Accelerated Aging of Sterile Medical Device Packages
General Determination Ageing Factor Determination Storage Period
o Basis for the storage simulation AAF  QAATAATRTTRT/10/10 

is the Arrhenius equation. AAF  Q10T10
o Increase in environmental Where:
temperature results into an
AAF: accelerated aging factor
increase of the reaction rate.
TAA: accelerated aging
o Observe the temperature temperature (°C)
tolerance limits of the ageing
TRT: ambient temperature (°C)
materials and the MD! Advice of
Q10: aging factor; typically 2.0
ASTM F 1980: below or at 60 °C
(conservative approach)
32
PLANNING OF A COMBINED STABILITY STUDY
EXAMPLE
Selected testing systems for performance test of the packaging
 Applicability of the systems
 Determination of the specification limits
Baseline – before Sterilization
Sampling Dates
Baseline - after sterilization
After transport simulation
After accelerated aging
1Y 3Y 5Y After real-time aging
1Y 3Y 5Y
Visual Inspection X X X X X X X X X
Peel Test X X X X X X X X X
Dye Test X X X X X X X X X
Test Systems
Burst Test X X X X X X X X X
Bubble Emission Test X X X X X X X X X
Air Permeability X X X X X X X X X
Functional Tests (X) X X X X X X X X

Biocompatibility (X) X (X) X X X X X X
33
OUR SERVICES IN ISO 11607-1
• Protocol and Test Plan generation

• Transportation and Distribution Testing.
• Accelerated and Real Time Testing
• Integrity testing
 Bubble test
 Peel test
 Dye test
 Burst Test
 Air Permeability
 Microbial Challenge
• Final reports
34
UL SERVICES
• UL has Competent persons and complete facility to perform all the test.
• UL can perform Functional test for active devices after Packaging test.
• UL can perform Transport Simulation in Shorter TAT.
• UL Chambers and Hot air oven can be remote Monitored.

• UL has experts in Packaging test , Microbiological test , functional and
performance test.
• UL is the only dedicated lab for testing Medical Devices.
35
THANK YOU
Version 1.0 / December 2017

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What are the main regulations and standards for medical device packaging?

What are the main regulations and standards for medical device packaging?

What are the different types of packaging tests mentioned in the document?

What are the different types of packaging tests mentioned in the document?

PACKAGING TESTING FOR

• Medical Device Packaging is highly regulated and must meet regulatory

Packages are tested, when?

New Design Design Change Material Change

• Many manufacture conduct packaging testing in-house or through third

Final consumption Transport

Factors influence the medical device product stability:

Packaging testing can be done at many stages of the product cycle:

• Protect the Product

Definition of sterile barrier systems as per ISO11607-2

Package validation Testing

Package Integrity Distribution Stability Testing

Test Procedures: Test Procedures: Test Procedures:

Compression Test ASTM D 642

Implementation of Compression Test (stack test), eg. Apply-and-hold method.

Drop (ASTM D 5487) Random Vibration Test (ASTM D 4728)

Result of Drop Test Result of Vibration

• To ensure the integrity of the package seal and packaging system

Integrity testing includes

Burst Test (ASTM Dye Penetration Bubble Test (ASTM

• Determine the burst • Introducing a dye • Submerging the

• No sealing failures (channels or holes at the sealing seam)

No channel = sealing seam is integral channel = sealing seam is not integral

Adhesive Cohesive Delamination

• Test using the following standard:

• Test using the following standard:

• Simulation of a medical device life cycle

o Basis for the storage simulation AAF  QAATAATRTTRT/10/10 

Baseline – before Sterilization

Bubble Emission Test X X X X X X X X X

Functional Tests (X) X X X X X X X X

• Protocol and Test Plan generation

• UL can perform Transport Simulation in Shorter TAT.

• UL Chambers and Hot air oven can be remote Monitored.

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