The process of designing and
developing a packaging system for terminally sterilized
medical devices is a complicated and critical endeavor.
The device components and the packaging system should be
combined to create a product that performs efficiently,
safely, and effectively in the hands of the user.
The packaging system shall be
designed to minimize the safety hazard to the user and
patient under the intended specified conditions of use.
The packaging system shall
provide physical protection and maintain integrity of the
sterile barrier system. The sterile barrier system shall
allow for sterilization and be compatible with the chosen
processes. The sterile barrier system shall maintain
sterility until the point of use or until the expiry date.
Maintenance of sterile barrier
integrity may be used to demonstrate maintenance of
sterility. The loss of sterility is regarded as
event-related rather than time-related. When similar
medical devices use the same packaging system, a rationale
for establishing similarities and identifying the
worst-case configuration shall be documented.
The sterile barrier system is
essential to ensure the safety of terminally sterilized
medical devices. Regulatory authorities recognize the
critical nature of sterile barrier systems by considering
them as an accessory or a component of a medical device.
Preformed sterile barrier systems sold to healthcare
facilities for use in internal sterilization are
considered as medical devices in many parts of the world.
One significant barrier to
harmonization was terminology. The terms “package,” “final
package,” “final pack,” “primary pack,” and “primary
package” all have different connotations around the globe,
and choosing one of these terms to be the harmonized basis
for this part of ISO 11607 was considered a barrier to
successful completion of this document.
As a result, the term “sterile
barrier system” was introduced to describe the minimum
packaging required to perform the unique functions
required of medical packaging: to allow sterilization, to
provide an acceptable microbial barrier, and to allow for
aseptic presentation. “Protective packaging” protects the
sterile barrier system, and together they form the
packaging system. “Preformed sterile barrier systems”
would include any partially assembled sterile barrier
systems such as pouches, header bags or hospital packaging
Key Drivers In
One is to help reduce
hospital-acquired infections, which requires packaging
that maintains its integrity, withstands sterilization,
and protects against damage to expensive devices.
A second trend is easy
identification and handling of medical devices that
require transparent packaging materials before and after
Third driver is cost
containment. Eastman is collaborating with packaging
engineers early on to understand their needs to work
through the packaging design process and material
selection, which helps them execute that design without
Sustainability Issues With
Regard To Medical Device Packaging
The safety of patients and the
healthcare professionals who interact with the packaging
are the top two priorities. Then the third part is
sustainability. There are emerging purchasing programs,
such as environmentally preferred purchasing, that examine
what happens to the packaging materials from an
Put quality systems in
place to define processes to eliminate hazards in
The goal of a thorough
packaging system hazard analysis is to eliminate all
high-severity hazards and reduce as many medium- and
low-severity hazards as possible. Two prime high-severity
hazards are breach of the sterile barrier (for a sterile
barrier package) and damage to the medical device, which
is not easily detectable and may impact the safe and
effective use of the device.
The number-one failure mode
for a sterile medical-device package is the loss of
physical package integrity, such as holes, tears,
punctures, and open seals. Hazard analyses will assist in
determining how the loss of physical integrity occurs in
your package design.
Develop design inputs
the mass and configuration of
the presence of sharp edges or
the need for physical and
the sensitivity of the product
to particular risks, e.g. radiation, moisture, mechanical
the number of products per
package labeling requirements;
expiry date limitations of the
Also Create a document that
defines product protection requirements, including
fragility, light, temperature, oxygen, and moisture,
before picking out packaging materials. Evaluate
competitive devices to understand how they package their
products—learn from the good and the bad examples.
ESSENTIAL FOR PACKAGE COMPLIANCE
storage, and handling
Perform a thorough analysis of
distribution conditions for your medical device. With
clinical trial packaging, you have low volumes of packages
being sent to many distant sites. Conduct an environmental
monitoring study of cold-chain packaging, understanding
how a package may be exposed to extreme conditions.
Understand that the
selection and evaluation of materials and sterilization
compatibility is critical.
Use real-time aging to test
package shelf life and stability