Page 110 - Assurance of Sterility for Sensitive Combination Products and Materials

94 Assurance of sterility for sensitive combination products and materials

carbonates to form in the solid dosage form, which decreases the disintegra-
tion and dissolution properties of the product. Packaging in tight containers
and filling the containers as full as possible minimize this condition [22–24].
Degradation of pharmaceuticals as well as label materials can be induced
by light. The effects of light can be minimized by packaging products in
light-resistant containers; products that are light sensitive can be covered
during administration with aluminum foil or an amber plastic overwrap.

5.2.7 Challenges for packaging combination products
As the development of combination products continues to evolve, so will
the challenges to effectively and economically package them. New technol-
ogies need to address unmet needs result in increasingly complex packages.
The packaging industry must keep pace with the rapidly evolving devel-
opment of new materials, sterilization methods, and technologies to deliver
these critical therapies to the patients safely and effectively.
One example of a new challenge is the packaging of biologics. The
Center for Biologics Evaluation and Research (CBER) states ‘In contrast
to most drugs that are chemically synthesized and their structure is known,
most biologics tend to be heat sensitive and susceptible to microbial con-
tamination. Therefore, it is necessary to use aseptic principles from initial
manufacturing steps which is also in contrast to most conventional drugs’
[31]. ‘Biologic products often represent the cutting-edge of biomedical re-
search and in time may offer the most effective means to treat a variety of
medical illnesses and conditions that currently have no other treatments
available.’ Biologics are from the human body or other biological entities,
such as vaccines, etc. These products are labile and very challenging to pack-
age. A typical medical device may be packaged and sterilized and have a
shelf life of 5 years, while a biologic may only be shelf stable for weeks.
This type of product will likely require a new method of filling or packing
and the development of compatible packaging materials. New materials in-
tended to contain biologics will likely require maximum barrier properties
as these biologics are sensitive to moisture, temperature, UV light, as well
as oxidation. Many combination products provide convenience for the user
to deliver a drug dose. Examples include prefilled syringes, insulin injector
pens, transdermal patches, metered dose inhalers, etc. In this case, a device
can be the drug container, the primary package as well as the delivery de-
vice (Fig. 5.5).
It is essential that packaging as well as sterilization are considered very early
in the development planning and design control for a device/ combination