Originally Published IVD Technology October 2004
Packaging and labeling materials and components
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| Süd-Chemie Performance Packaging (Belen, NM) offers a wide range of solutions to protect diagnostic test kits and strips from moisture, including desiccant tablets, desiccant packets, and polymer product solutions. |
It often surprises those outside the packaging engineering discipline that a
packaging philosophy actually exists. According to this philosophy, the packaging
for every diagnostic kit must protect, contain, and describe the contents. This
philosophy applies whether the IVD is a state-of-the-art automated platform
or an over-the-counter pregnancy kit retailed at a local supermarket.
The overriding concern of every IVD packaging team is maintaining quality through
protective packaging. The close link between quality and packaging is important
since testing and validation requirements will continue to increase, not decrease,
in the future.
The packaging team focuses on ensuring that the package and the test it protects
are an integrated unit and indistinguishable if separated. For example, an aerosol
product cannot be distinguished from the package that dispenses it. The product
is the package. Product and packaging development are done in conjunction on
an interactive basis.
Suppliers are also closely involved in IVD packaging development. Raw-material
vendors supply film and foil converters, containers, and closures that have
product contact and are considered primary packaging components. Other such
primary components include desiccants that absorb moisture and specialty products
that absorb oxygen and odors.
Secondary packaging components that do not involve product contact include labels,
kit cartons, corrugated shipping containers, blister packs, trays, and foil
or laminate overwraps. For distribution, or tertiary, packaging, IVD manufacturers
need to purchase pallets, strapping, and stretch- or shrink-wrap, as well as
work with consulting and testing laboratories.
Packaging, labeling, and distributing IVDs are complex processes involving many
industries, manufacturing companies, and countless service fields. A packaging
philosophy exists to guide and service these many applications.
Basic Packaging Tenets
As stated above, IVD packaging must protect, contain, and describe the tests
in a quality environment. These basic tenets are strictly followed as the packaging
is developed and must be reviewed during development.
The goal of protection is the packaging’s ability to prevent harm to an
IVD product (e.g., damage from unwanted moisture or oxygen). A quality package
also prevents a product from inflicting harm to the environment or end-users
(e.g., sharp edges, serum-based tests). Since IVDs often involve human serum,
as well as corrosive, poisonous, or radioactive materials, developing and testing
compliant packaging is critical. Quality and protection are intertwined as the
foundations of IVD packaging.
With containment, the packaging provides convenience to those persons who handle
and use IVDs. The packaging should not only provide convenience to final customers,
but also be user-friendly for those that manufacture, transport, distribute,
warehouse, and retail the final product. Containment may also be called unitization,
in which an IVD product is divided into usable quantities.
Description or identification via package labeling and product inserts is how
IVD manufacturers communicate with consumers. Complying with packaging rules
and regulations demands continuous quality improvements to the labeling. For
example, if tests contain hazardous components, manufacturers must introduce
specific warning labeling and marking. If IVD manufacturers market products
overseas, they must revise the labels accordingly.
Protecting against Moisture
With any new and existing packaging, even a little bit of moisture is not good.
IVD companies maintain packaging design and testing labs that are responsible
for the integrity of the primary container and closure systems. In conducting
the tests, the labs follow packaging standards developed by the American
Society for Testing and Materials (ASTM; West Conshohocken, PA).
The packaging engineering team must design bottles, caps, pouches, and accessories
that guard against moisture damage during an IVD’s normal life cycle. One
form of protection against moisture can be achieved by properly designing and
using desiccants, such as packets, canisters, tablets, or cap inserts. An IVD’s
shelf life is increased as product degradation is decreased.
During the prototype stage, leak testing is necessary to discover potential
problems. When introducing new or modified container and closure systems, identifying
potential defects is critical. IVDs are often exposed to extreme temperature
changes during shipment, which can lead to leaks. The packaging is conditioned
and then tested to ensure resistance against moisture.
For example, depending on the final IVD product requirements, new bottle and
closure combinations may be subjected to laboratory stress testing. Labs perform
stress tests to determine their ability to endure temperature extremes ranging
from –70 to 50°C.
Traditional bottles and caps are not always used for IVDs. New packaging may
consist of multilayer foil and plastic composite pouch materials. After being
conditioned, such flexible materials will also be stress tested to detect pinholes
and leaks.
Shock and Vibration Testing
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| Technipaq Inc. (Crystal Lake, IL) provides packages that can be tailored to achieve required porosity levels, mechanical-strength and barrier properties, seal integrity, and sterilization methods. |
In today’s distribution environment, IVD kits need to be rugged. IVD manufacturers
must package their products to guard against shock and vibration damage during
truck, railroad, and airline shipping. Vibration damage can take many forms
since IVD products are accelerated and decelerated thousands of times a minute
during shipment to customers. The products are also subjected to repetitive
and random shock sequences.
Vibrations affecting product and packaging integrity come from many distribution
sources. IVD manufacturers need to implement distribution packaging development
and testing. Such testing is conducted in accordance with standards developed
by the International Safe Transit Association (ISTA; East Lansing, MI)
and ASTM.
Product and packaging should be tested from 0 to 1000 Hz, which simulates shipping
via truck, railroad, and airplane. Such vibration testing prior to shipment
prevents damage that is unseen during transit and not apparent until the customer
receives the final kit.
While real-life field testing that recreates actual shipping by truck, train,
and airplane distribution is the only way to truly review packaging and product
protection, there are alternatives. Many packaging testing labs can conduct
repeatable motion testing with vibration tables. Such vibration tables allow
engineers to analyze product packaging during distribution so the IVD manufacturers
can safeguard against damage. Full pallet distribution loads can also be tested
on vibration tables.
Another alternative is using an accelerometer, which is a small instrument designed
to measure acceleration. The instruments are modified for package stress testing
and are used to pinpoint product design strengths and weaknesses. For example,
liquid-reagent concerns about foaming can be studied.
As shock and vibration testing has evolved, distribution testing has become
even more complex. The test equipment can be programmed to simulate simple or
complex vibration waveforms. Such testing helps to determine the resonance frequencies
of individual parts, the whole IVD product, or the packaging system. Resonance
occurs when the input frequency is the same as the natural frequency of the
product or packaging system, which causes damage to the product. Packaging engineers
can design the proper packaging that allows the shipping container and tonnage,
not the IVD kit, to absorb the damage.
Bottles, caps, and pouches can become susceptible to leakage due to multiple
vibration frequencies. After distribution packaging testing, the packaging engineering
team may have to modify the secondary packaging to eliminate any leakage.
Protective dunnage or cushioning can be designed to prevent leakage. Such packaging
includes expanded polystyrene foam, open- or closed-cell foams, inflatable pillows,
and corrugate. Returnable packaging and dunnage can also be created if a closed-loop
system can be defined.
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| Saf-T-Pak Inc. (Edmonton, SK, Canada) manufactures packaging for the transport of infectious substances and diagnostic specimens. |
Other distribution damage can be equally detrimental to product performance
and customer satisfaction. As labeling and printed materials are critical during
a test’s life cycle, the printed components must be subjected to printed-commodity
qualification and material structural evaluation. Such testing must be done
since elevated or frozen temperatures and relative humidities will cause label-adhesion
problems.
Scuffing and abrasion occurs when printed cartons and labels rub against each
other during shipment. Such damage can also occur as cartons rub against the
interior of corrugated containers during distribution. Label or carton vendors
will work with packaging design teams in selecting proper label and carton stock,
as well as the correct rub-resistant inks or overcoats to minimize damage.
As IVD manufacturers ship more around the world, they should also conduct refrigerated-shipment
development and testing for components using dry- and wet-ice shipments. At
times, distribution packaging will require insulated shipping containers, refrigerated
or frozen gel packs, and temperature-monitoring devices. Temperature monitors
used during shipment provide product security. However, they are no substitute
for testing at the front end.
Conclusion
The formal education history of packaging engineers is still relatively short,
having had its origin in the 1950s. This article provides an introduction to
the complexity of the overall packaging design and testing processes. Product
and packaging compatibility, product quality and safety, production line performance,
and solid-waste management all lend themselves to many other articles and entire
reference books.
The packaging and labeling of an individual IVD test or a complex kit are essential
parts of the overall product design. Proper packaging, labeling, and design
testing make it possible for an efficient system of mass, worldwide distribution
of IVDs. By doing so, such protection, containment, and identification continue
to contribute to the well-being of customers and their quality of life.
Robert P. Adams,
Abbott Laboratories (Abbott Park, IL)
Copyright ©2004 IVD Technology
