TESTING & VALIDATION OF
MEDICAL DEVICE PACKAGING
Dr. R. Rangaprasad
Definition of a Medical Device
The Global Harmonization Task Force (GHTF)
proposed the following harmonized definition of a medical
Any instrument, apparatus, implement,
machine, appliance, implant in vitro reagent or
calibrator, software, material, or other similar or
Intended by the manufacturer to be used, alone or in
combination, for human beings for one or more of the
specific purpose(s) of:
Diagnosis, prevention, monitoring, treatment, or
alleviation of disease.
Diagnosis, monitoring, treatment, alleviation of, or
compensation for an injury.
Investigation, replacement, modification, or support of
the anatomy or of a physiological process.
Supporting or sustaining life.
Control of contraception.
Disinfection of medical devices.
Providing information for medical or diagnostic purposes
by means of in vitro examination of specimens derived from
the human body, and
b. Which does not achieve its primary intended action in
or on the human body by pharmacological, immunological, or
metabolic means, but which may be assisted in its intended
function by such means.
By definition, devices are involved in many different
aspects of healthcare. As such, devices, their
manufacturing processes, and the packaging that contains
and protects them are extremely disparate. Complicated
capital equipment, such as MRI tunnels and X-ray machines,
are medical devices, but so are simple, commodity-like
items such as tongue depressors and syringes. Some are
meant for mass markets; others are niche items. Some are
packaged individually; others are packaged in boxes of 100
s or 1000 s. Some are reprocessed, others are disposable,
and some are used for a lifetime. Risks associated with
device misuse and failures are equally varied, ranging
from inconvenience to patient death.
Classification of Medical Devices
The great variation present in the medical device industry
means that devices can be classified in a number of ways.
Devices can be categorized by:
The risk associated with improper use or a failure
(generally high, moderate, and low).
Conditions of processing (reusable, disposable, capital
Conditions of the therapy (invasive, noninvasive).
Conditions of shipping and handling (capital equipment,
commodity surgical, etc.).
Because the goal of these therapies is to maximize
efficacy and protect patient safety, the most common way
to classify devices is based on risk.
Key Considerations for The Development of Medical Device
In addition to the normal functions of a packaging system,
the following requirements are unique to Medical Devices.
Sterile Barrier System
The vital importance of maintenance of the sterile barrier
system (SBS) is a distinctive characteristic of medical
device packaging. Medical device packaging for disposables
must not only maintain the SBS but, in many cases, also
facilitate the sterilization of the device within. Such
protective characteristics can be achieved
through the package shape, particularly in thermoformed
parts, in order to avoid product shifting or to keep kit
components separated or nested. For sealed packages, seal
integrity is an important characteristic in product
protection. Seals must be free of channels and must
withstand the rigors of sterilization and transit.
Utility is related to the ease of use of the system. For
many medical devices, quick and easy opening and removal
of contents are crucial. While this consideration is also
important for devices with relatively low risk, such as an
adhesive bandage, it is extremely critical for sterile
medical devices that are used in surgical arenas where the
packaging must allow the device to be removed without
contamination. This particular need has led to the
development of special materials and sealants that, when
used in combination, can provide package strengths that
are adequate to endure the severity of processing and, at
the same time, can be manually opened without imposing
excessive stress on product or user.
As with consumer goods packaging, secondary and primary
medical device packages are a means to convey information
through graphics, materials, and shape. Packaging
communication operates at different levels, depending on
the type of medical device.
For over-the-counter (OTC) medical devices, such as
condoms, glucose meters, adhesive bandages, thermometers,
and so on, the communication role involves motivating a
purchase, as well communicating important information for
the safe and effective use of the medical device.
Information may include directions, warnings, product
benefits, brand differentiation, and so on. A very
important aspect of package communication is product
identification. This is especially true for devices that
go into institutional settings, such as hospitals, where
personnel may have to identify the correct device for a
patient when seconds count.
Key Package Design Considerations
During the early design stages, it is critical to define
the following parameters:
Critical product characteristics.
Type(s) of protection required (physical, ultraviolet
light, O2, water vapor transmission, etc.).
Type of sterilization process.
Where and how the product is going to be
dispensed (OTC, surgery, etc.).
Medical device packaging requirements
Complying with packaging requirements is the
responsibility of the medical device manufacturer. This is
the only way to guarantee that the products will be
protected during transportation, and that they comply with
health and safety regulations.
Pharmaceutical and medical products have certain special
characteristics (such as their limited shelf life). For
this reason, their requirements for transportation and
commercialization must be aligned with them.
The protocols aimed at guaranteeing their safety focus on
factors such as the seal integrity, materials or how the
package reacts to the passage of time.
At a government level, the most important regulations are
those of the Food & Drug Administration (FDA) in the
United States, and the Medical Devices Directive in the
Medical device packaging doesnt just need to arrive at
the hospital, clinic, or end customer free from holes,
tears or missing seals; it must also withstand the passage
of time in storage, where it must be able to remain for
years without the drug or device having their composition