Page 144 - Assurance of Sterility for Sensitive Combination Products and Materials

126 Assurance of sterility for sensitive combination products and materials

software technology are the basis for this technology. While electronic
componentry has long been a part of medical devices, it is relatively
new to packaging materials. The industry has had to adapt by developing
packaging to contain the electronic componentry and such advance-
ments as the ability to print electronics on a package or device. Sensor
technology can be integrated into packaging to monitor the opening of
the package or environmental conditions. It is important to understand
if there are any compatibility concerns with the electronic components
and the proposed method of sterilization. Knowledge of the method and
the ranges and durations of the input parameters is very important for
the assessment.
An example of a new system for the integration of a drug and a de-
livery device is a drinking straw filled with a medication dosage form
of pellets; ‘XStraw’ by Dose Sipping Technologies [96]. The exact dose
is contained within the straw that contains a control filter so no medi-
cation is wasted. This design is an excellent method to assist children or
the elderly with taking their medication. To contain the filled straw, new
packaging was developed consisting of polypropylene and an aluminum
blister that provide an air tight system which does not require any special
storage conditions.
An example of polymer technology evolving to meet the market needs
is the development of the family of cyclic olefin homopolymers and co-
polymers. The family is providing needed performance improvements for
several types of health-care product packages. These thermoplastics can be
injection molded, extruded, or coextruded to make both rigid or flexible
packaging materials. The plastics are inert, pure, safe, and optically clear.
Their inert properties make them compatible with gas, steam, and radiation
methods of sterilization. These materials offer an excellent alternative to
glass vials, bottles, and prefilled glass syringes because of their high opti-
cal clarity, excellent moisture barrier properties, and minimal extractables
and leachables. Packaging constructed of this material is superior to glass
because of its light weight, resistance to breaking, and its elimination of sili-
cone lubricants. The cyclic polyolefins also have found its way into
1. Adhesive systems for medication patches that directly adhere to the pa-
tient skin,
2. Packaging that are used in rigid and flexible thermoforming as an alter-
native to polyethylene terephthalate glycol (PETG) and polyvinyl chlo-
ride (PVC) for rigid or flexible thermoforming,
3. Heat sealing layers for devices and pharmaceuticals that do not adsorb or