Page 228 - Biomedical Engineering and Design Handbook Volume 2, Applications

STERILE MEDICAL DEVICE PACKAGE DEVELOPMENT 207

package, and the storage and handling of the package. A manufacturer must become intimately
involved with how the product is packaged and how to maintain consistency and uniformity. He must
have proof that a process performs as it was intended.
The process validation (PV) consists of a series of qualifications of the processes making up the
complete package system. These processes include the installation qualification (IQ), operational
qualification (OQ), and performance qualification (PQ). Each facet of the packaging system must be
challenged and qualified in order to claim validation of the entire system.
ISO 11607 addresses the package system validation in three phases or clauses. Clause 4 specifies
the basic attributes required for a wide range of materials as they combine and interact with various
medical devices, packaging designs, sterilization methods, and distribution modes. Clause 5 defines
the framework of activities to qualify the processes used to make and assemble the final package
configuration. Clause 6 is intended to assist in the selection of tests and to provide criteria that can
be used to evaluate the performance of the final package.

7.7.3 Why Is Package Validation Important?

The primary objective of a package process validation should be to provide the medical device man-
ufacturer with a high degree of assurance that his product will reach the user in a condition suitable
for optimum functionality for its intended purpose, that is, provide a safe and effective medical
device.
The specific benefits of the package process validation include not only reducing the manufac-
turer’s risk of product malfunction or the potential of a nonsterile operating condition but also
improved customer satisfaction, improved manufacturing efficiencies, reduced costs, reduced devel-
opment time, and compliance to regulatory requirements. The “Guideline on General Principles of
Process Validation” provides valuable understanding on quality systems requirements and may be
relied upon with the assurance of its acceptability to FDA.

7.7.4 The Complete Package Validation Process
Prior to beginning any work on a validation, it is essential to write a protocol. The protocol provides a
blueprint stating how testing is to be conducted, including the purpose, scope, responsibilities, test para-
meters, production equipment and settings, and the acceptance criteria for the test. Validation requires
careful planning and preparation, and it begins with a well-conceived and well-written protocol.
As was mentioned earlier, the validation process consists of a series of qualifications of unique
processes that make up the complete package process system. This total package process system
includes the final package design, the materials chosen for the package, and the ability to consis-
tently sterilize the product inside its package. The design of the package and its dynamic interactions
with the product, the machinery used to assemble the package, the setup and maintenance of the
machine, and consistency of production are other important considerations. If one of these processes
is not right, the entire system breaks down and the manufacturer is at risk of malfeasance.

7.7.5 Package Forming and Sealing
While working with a packaging vendor, the package design has been completed. Vendors are usu-
ally responsible for validating that the materials are compatible with the sterilization process, and
that compliance qualification tests are conducted. This responsibility should be clearly communi-
cated and agreed upon during vendor selection and negotiation. Appropriate materials have been
selected and validated for compatibility with the intended product by the manufacturer. But how will
we assemble the product into the package using the most efficient and consistent process? The pack-
age sealing equipment for the job is identified and purchased; however, it must be properly installed
before producing finished packages. Before starting final process development, it must be demon-
strated that the process equipment and ancillary systems are capable of consistently operating within