Medical Device Industry- Packaging and Distribution study

1. PACKAGING AND
DISTRIBUTION STUDY

2. PACKAGING AND DISTRIBUTION
• Accelerated & Real-Time Aging
• Altitude Testing
• Climatic Conditioning Testing
• Cold Chain Testing
• Container Compression Test
• Dangerous Goods Package Testing
• Impact & Drop Testing
• Package Transportation Testing
• Rub & Abrasion Testing
• Shock Testing
• Temperature & Humidity Testing
• Vibration Testing

3. WHAT IS PACKAGE TRANSPORTATION TESTING?
Package transportation testing is used to determine how a packaged product
will perform under simulated environmental and distribution conditions.
The tests will determine if the packaging and cushioning materials being used
will protect its contents while being transported and stored.

4. WHY PACKAGE TRANSPORTATION STUDY ?
• To validate package performance
• To reduce product damage in transit
• To introduce an appropriate level of package
protection
• To evaluate whether cost savings can be made by
removing excessive packaging

5. PACKAGING TEST INCLUDE
• Protocol and test plan
• Sampling programs
• Transportation testing
• Shelf life
– Stability studies
– Aging (accelerated and real time)
• Integrity testing:
– Bubble leak
– Tensile/peel
– Dye penetration
– Vacuum decay
– Burst test
– Microbial challenge

6. SHOCK TESTING
• short duration of high amplitude pulses
that simulate a sudden acceleration.
• similar to vibration analysis
• simulate shocks and impacts to define
the degree product is damaged /fails.
• Calibrated vibration equipment is used
expose to poor mechanical layout,
miss-alignment of components, and
weaknesses in brittle materials like
plastic and glass.
STANDARDS:
ASTM D880, D999, D4728 and D6344,
IEC 60068-2-6, IEC 60068-2-27 and IEC
60068-2-29.

7. VIBRATION TESTING
• Random and sine test methods are used
for vibration testing.
• Random vibration is better simulation of
actual transport and preferred method.
• It will stimulate and accelerate mechanical
fatigue by exposing weaknesses,
deformities, cracks, imperfections
• Exposes poor connectivity on connectors
and overall poor mechanical layout.
• Sinusoidal, /sine, is used in conjunction
with the random method to determine and
observe resonances.
• It will stimulate and accelerate unwanted
resonances, which, if not detected and
fixed, will lead to early life failure.

8. HUMIDITY AND TEMPERATURE TESTING
What is Humidity Testing?
• Exposing products to humidity stress in an environmental chamber precipitates
corrosion by causing oxidation, contamination, and electro migration defects.
• Humidity can penetrate porous materials causing leakage between electrical
conductors.
• Moisture can cause swelling in material and is also an important stress factor when
evaluating coatings and seals.
What is Temperature Testing?
• Temperature testing is the process of subjecting units under test to extreme heat
and/or cold, as dictated by relevant standards or by the Customer, in order to
reveal possible latent defects or areas of concern.
• The imposition of temperature stress is one of the most common test methods in
order to simulate real-world storage and distribution conditions.

9. CONTAINER COMPRESSION TESTING
To determining the behavior of packaging and/or products under a
crushing or compressive force.
This testing is used in both package and product design verification to
determine the strength and structural integrity.
This testing is intended to recreate compressive loads that may occur
during warehouse storage or vehicle transport.
• Minimize damage costs and ensure the product’s packaging will be
adequate to give high levels of protection for worldwide distribution
• Determine if the packaging can withstand being stacked, height it can
be stacked without damage

10. RUB AND ABRASION TESTING
• Abrasion/rub testing is used to evaluate the scuffing /rubbing resistance of the
printed or coated surface of paper, paperboard, film, container board,
corrugated board, and other materials. The test is used to assess what
damage to printed materials can occur during shipment, storage, and
handling.
• Abrasion between materials during shipment, storage, and handling can
cause product appearance issues that may result in a reduction of legibility to
critical product information. The reduced legibility of print on labels or other
materials can be detrimental on medical device and pharmaceutical products.
• Methods: Dry rub, Wet rub, Wet bleed or transfer, Wet smear and Functional
rub
• Applicable to labels, folding cartons, corrugated boxes, inserts, circulars, and
other packaging materials that have graphics applied on a flat substrate.

11. AGING STUDIES
• Accelerated aging is used to simulate the effects of real-time aging by
subjecting samples to elevated temperatures for specific periods of time. It
also helps provide data that allows the manufacturer to accurately predict the
effect of real-time aging on a package and its enclosed product.
• Manufacturer must also conduct real-time studies in order to substantiate the
data generated during the accelerated aging process.
• Accelerated aging techniques are based on the chemical reactions involved
the deterioration of materials follow the Arrhenius reaction rate function. This
function states that a 10°C increase /decrease in the temperature of a
homogenous process results in approximately two times or ½ time change in
the rate of a chemical reaction.
• At 55°C, 6.5 weeks is equivalent to one year on-the-shelf. For example, at
55°C, 13.0 weeks would be equivalent to two years, and 32.5 weeks is
equivalent to five years.

12. CLIMATIC CONDITION TESTING
• Testing, involves exposing a package / product to different controlled levels of
temperature and humidity inside a calibrated test chamber. This simulates a
range of climatic changes that may occur during distribution.
• Different environments create different changes in physical properties of a
product or packaging. The tests including humidity and thermal testing,
simulate varying extremes of hot, cold, dry, and humid environments that
cause degradation in the product or package.
• These conditions can expose flaws in packaging, such as seals and glue
joints becoming impaired and packaging getting damaged, impairing the
package’s ability to protect the product

13. CLIMATIC CONDITION TEST

14. INTEGRITY TESTING
Bubble
Leak
Testing
Burst
Testing
Dye
Penetrati
on
Testing
Medical
Device
Packaging
Package
Integrity
& Seal
Strength
Testing
Peel And
Tensile
Testing
Rub &
Abrasion
Testing

15. WE ARE DEDICATED TO MAINTAINING A NATURAL,
SAFE AND GREEN ENVIRONMENT…
so that our children can enjoy the same resources
and beauty that we have for generations.

16. Contact us for more information:
regulatory.one@yahoo.com
info@regulatory1.in