© Copyright ISPE 2009. All rights reserved.

www.ISPE.org
ISPE
Knowledge Brief
by David Williams
Fundamental
KB-0015-Oct09
Packaging Material
Selection: Things to
Consider
Introduction
Packaging materials (components)
form an integral part of most, if not all,
pharmaceutical products and devices
and for this reason they need full
consideration during the development
and production life cycle of the product.
Too often, this consideration is at best
minimal and at worst non-existent.
This Knowledge Brief is not intended to
give all the answers, rather to provoke
the questions that need answers before
a packaging material can be safely used
for a pharmaceutical product. It will look
briefy at the major types of packaging
materials, how they are manufactured,
and some issues for consideration to
achieve stability of the product with the
immediate container, closure system –
the most important feature of a packaging
material. This knowledge contributes to
stability studies that are required to be
submitted to the governing agencies
before a particular material can be used.
Detailed specifcations are required on
all packaging materials and testing for
conformance to the specifcations is
critical.
Turn to the Experts
Packaging materials are a science in
their own right, and as such, need the
services of a specialist – a packaging
technologist (Europe) or engineer (USA).
Not only do you need in house expertise,
but success will come easier when
you work in close partnership with the
component suppliers. They know their
processes and what can realistically
be expected from a given technique or
methodology on a daily basis. This is not
to say that you should not push suppliers
to work on cutting edge developments.
However, if you do, you need to be
aware of where those edges are, the
possible disadvantages, and most
importantly, what controls are required to
avoid going over those edges.
Some suppliers may not divulge all of
their technical details or constituents
of the components, preferring to keep
confdentiality through supplying these
details in confdence to the various
regulatory authorities.
Better Understanding Yields
Better Results
No matter what material you are
Page 2 ISPE Knowledge Brief
Packaging Material Selection: Things to Consider
© Copyright ISPE 2009. All rights reserved.
using, it is imperative to have a full
understanding of the constituents of the
component(s). You also should have the
understanding of how the component is
manufactured and what manufacturing
aids are utilized. The only way to be
sure of what manufacturing aids are
used is by physically following the raw
materials through the process from their
raw material warehouse to delivery
at your premises. This should not be
confused with or substituted by a quality
conformance audit.
When selecting a packaging material,
a full understanding of the product to
be packaged is required, along with the
performance required. This performance
could vary from shelf life to moisture
resistance through to droplet size.
The more information, the increased
likelihood that better performing and cost-
effective packaging can be developed
and delivered. With the emphasis on lean
manufacturing, it may be worth spending
relatively more on the initial purchase
of the packaging component to be able
to gain more consistent production and
lower waste, giving a lower cost of goods
price to the customer.
Common Packaging Materials
Here is a brief look at the various
common individual packaging materials,
highlighting some of the key issues
that need consideration. This is not an
exhaustive list and consideration also
should be given to the regulatory needs
of each country in which the product will
be marketed.
Glass
Glass is one of the oldest packaging
materials and has the great beneft of
being almost inert. The caveat to this
is in the feld of the newer biological
molecules which can react with trace
metal ions in the glass formulation. The
raw materials for glass are dug out of the
ground and melted (fused) together. As
a consequence, raw materials can vary
for each manufacturer even if the fnal
products are all sold as “type 1” glass.
For pharmaceuticals, glass is usually
described by the hydrolytic resistance
as type 1, 2 or 3, conveying different
properties in terms of product longevity
and use.
Glass is typically manufactured on a
campaign basis where a glass furnace
produces one type of glass for a period
of weeks or months. Molded glass
containers are produced near a furnace;
therefore, they are totally reliant on the
formulations in that furnace.
Tubular glass products, such as
cartridges, syringes, ampoules, rely on
“bulk” tubes produced near the furnace
and are often stored and shipped
to converters. This, to some extent,
removes the reliance on the furnace
campaign.
There are two effects of this type of
manufacturing campaign:
1. Glass manufacturers often ask for
an annual order for a given bottle,
then may produce a year’s stock in
one production run, and then ship
in smaller lots to the fller. This can
be an issue with amber glass bottles
when sales exceed initial forecasts.
2. During a specifcation change to
a molded glass container, while
the change may be quickly agreed
upon by all parties, the practical
considerations of how to dispose
of the stock in the suppliers
warehouse often is a delaying factor.
If the decision is made to deplete
existing stock, it could mean that
the specifcation change is not seen
in production for several months
following agreement.
The above emphasizes the need to
understand how your supplier(s) operate
and your packaging requirements.
Plastics
Plastics are very complex formulations
and can have many processing
aids added in manufacturing. The
constituents and these additives can
both be extracted and leach out into the
product. This is especially a concern if
the pharmaceutical product is a liquid.
Considerable care needs to be taken to
ensure these leachables do not render
the product unft for use throughout its
designated shelf life.
Plastics are polymers that are built up
from repeating monomers that are joined
in a variety of forms and are produced
by a number of different methods. Many
of these methods involve the use of
additives and catalysts, all of which are
present in the fnal formulation.
Polymer production facilities are
invariably built using the latest
technology, making each production
facility unique. Thus a grade of polymer
produced in plant A will be different
than the “same” grade of polymer
produced in plant B. This will hold true
even if the polymer has the same name
and is supplied by the same supplier.
These differences may or may not
make a difference to your product.
Full understanding and testing will be
required.
In addition to the fundamental
differences built in during the
manufacture of the polymer, conversion
of the polymer to the fnal packaging or
device component will invariably add
other ingredients to give the performance
required by the user.
Some typical additives are UV inhibitors,
anti block/slip agents, plasticisers,
antioxidants, colors (dyes and pigments),
stablizers, and lubricants. Each of
these will convey a modifcation of the
polymer properties and will require full
understanding in terms of its effect or
lack of, on your product.
Many component suppliers include these
additives during the molding operation
or even spray them onto the fnal mold
to facilitate release of the components.
Each component supplier has their own
ways of working and preferred suppliers.
Therefore, a component molded by two
suppliers using the same base polymer
could have very different chemical
profles when examined analytically. The
bottom line is that while components
from two different suppliers may look
ISPE Knowledge Brief Page 3
Packaging Material Selection: Things to Consider
© Copyright ISPE 2009. All rights reserved.
identical, they could have very different
formulations.
Resins produced for Blow/Fill/Seal
(B/F/S) applications should have
minimal adulteration from additives,
due to the nature of the B/F/S process
which requires the use of basic material
free from plasticizers and antioxidants.
No mold release should be used with
B/F/S technology and colorant must
meet the same stringent non-additive
requirements as base resin.
The above may or may not matter to
your product; hence, the need to fully
understand the needs of your product.
Metals
Metals are used in many packaging
applications. Aluminum is used in
blisters, overseals, and induction heat
seals. Steel can be used for syringe
needles and springs in devices, such as
injections or inhalations.
Consideration should be given to the
grades of steel and purity of metals
that are combined with any processing
aids (chemicals). If aluminum foil will be
printed and sealed, print receptive and
heat sealable layers need to be added to
the base metal.
Secondary and Tertiary
Packaging
Secondary packaging is the term used
to describe items, such as the carton,
labels, and leafets (inserts), while
tertiary packaging looks at transport
packaging, such as shippers and pallets.
Many products use cartons to collate a
number of packs, such as blisters and
information or instruction leafets. As with
primary packaging materials, there is
considerable technology behind paper
based packaging. For example, cartons
from one supplier may not work as well
as those from another. They may look
as good, but fail to perform when being
flled on the production line, resulting in
increased levels of rework and/or scrap.
Tertiary packaging requires detailed
knowledge of where the product is being
marketed as well as how the product is
going to reach the market. This routing
will determine the protection required
and if any transit legislation must be met.
Conclusion
There cannot be a pharmaceutical
product on the market without a greater
or lesser degree of packaging used to
get the product to and promote patient
compliance. The few examples above
should demonstrate the need to consider
packaging early on in the development
process and throughout the production
life cycle.
All packaging components are not
equal even if they look identical.
Full understanding of the materials,
conversion, and use of the component
is required to ensure that the packaging
materials selected give the required
performance in the most economical
fashion.
For Further Information
For more detailed and related
information, the following ISPE
resources are available:
Recorded Webinars:
• Enabling On-Demand: A Practical
Alternative to the Traditional Method
of Packaging and Labeling of Clinical
Supplies
http://www.ispe.org/onlinelearning
• Packaging Evolution – Research
Through Launch – The
Considerations
http://www.ispe.org/onlinelearning
Publications:
• Pharmaceutical Engineering, March/
April 2002, Volume 2, Number 2
http://www.ispe.org/
pharmaceuticalengineering
Packaging Community of Practice
(COP):
• Visit our Packaging COP on the
ISPE Web site for the most current
and up-to-the-minute discussions on
packaging materials and other related
topics.
http://www.ispe.org/
communitiesofpractice
About the Author
David Williams has more than 35 years
of experience in packaging across a
wide range of industries, components,
and techniques since achieving an
honors degree in bacteriology from
Trinity College, Dublin. His lifelong
interest in packaging started when
he joined the research department of
Jefferson Smurft before subsequently
working with Loctite and then National
Adhesives. He joined the pharmaceutical
industry in 1987 and spent more than
15 years with GlaxoSmithKline (GSK).
Packaging technology roles within
GSK included responsibility for material
specifcations, the investigation of
suspect packs, and the introduction
of new technologies with both site
and global project and management
responsibilities. He holds a Masters
degree in project management and
was elected a Fellow of the Institute of
Packaging. He runs his own consultancy
specializing in the benefts of packaging
technology and project management.

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