ABSTRACT
Product and package sterility are expected and assumed by anyone taking a drug.
It is viewed as a requirement, a given, a normal expectation for all pharma-
ceutical products and all pharmaceutical packaging. Few people realize that
producing a sterile product means sterilizing the product and the package in the
same process. Sterilization places many unique demands and requirements on a
package. Sterilization is a key process component for any product and package
development program. It is here that the two entities, product and package,
become inextricably linked. The packaging is considered part of the product by
the FDA and must be capable of preventing any contamination or adulteration of
the product. What few outside observers do not realize is that the packaging
provides the means for sterilizing the product and that the primary package is the
most important barrier for maintaining sterility. Many products are sterilized
after packaging, particularly medical devices that require intricate assembly and
contain many different materials and components. Many of the components and
materials cannot be sterilized by themselves and must rely on the packaging to
protect them while they are undergoing sterilization. Even simple items like
infusion sets have multiple components that must be sterilized after final
assembly. These devices are made of many diverse materials needed to make
them work, which complicate their packaging and sterilization.
