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Key
Essentials For The Perfect Medical Device Packaging
1. Packaging Design
Requirements
Packaging design should
highlight a clear expectation of the function,
limitations, special features, aesthetics, product/company
branding, cost limitations, size limitations,
sterilization method, labeling requirements, storage
requirements, and possible adverse conditions of use
and/or distribution and storage.
2. Packaging System Hazard
Analysis
Goal is to eliminate all
high-severity hazards and reduce as many medium and
low-severity hazards as possible. Two prime high-severity
hazards are breaching the sterile barrier and damage to
the medical device that may impact its safe and effective
use.
3. Clinical Application Of
The Sterile Medical Device
One should gather information on the direct use of their
sterile medical device on the patient so that the specific
role their packaging system plays in the device will be
safe and effective use.
4. Distribution, Storage,
And Handling Of The Medical Device
Today’s increasingly complex
supply chains require the package designer to perform a
thorough investigation of the anticipated distribution,
storage, and handling conditions of their medical device.
5. Prototype The Packaging
System
Prototyping packages will give
the opportunity to evaluate the performance of different
sterile barrier system designs. Parallel path development
of multiple design options will help ensure project and
timeline success.
6. Evaluating The Sterile
Barrier System, including simulated or real devices, for
these top issues:
• The package can be
effectively sterilized via the designated method.
• The package does not damage the device or present a risk
to patient safety (sterility breach).
• The package/device can be assembled with a time standard
acceptable to your manufacturing team.
Ref:
http://www.medicalpackaginginnovation.com/author.asp?section_id=572&doc_id=559517&
With the continuing growth of
the Medical Device Industry, the need for Sterilizable
Packaging and other packaging requirements for medical/
surgical products is increasing. With increased
performance requirements, medical packaging converters and
material suppliers have to face challenges to provide
products to satisfy the needs.
In order to put before the
Medical Device & Allied Industry the views of Material
Manufacturers, Converters & Service Providers, “Medial
Plastics Data Service” closely interacted with some
leading companies to have their precious views, vision &
opinions about Medical Packaging and the Criteria met by
their materials and services.
We are really very grateful to
and thank the Leaders, Experts and Technocrats for their
valuable contribution and co-operation by spending their
most precious time and
sharing their rich experience, knowledge and vision.
We are reproducing herewith
our dialogue with few of the Experts for benefit of the
industry. The experts examined the following aspects for
which their views are summarized in this article:
Packaging Material
Selection
a) Selection Criteria And
Critical Factors
b) Emerging Global Trends
c) Requirements For Design Of Material
d) Implications Of Material Selection On Design And
Packaging Machinery
e) How To Reduce The Cost Of Packaging Without
Compromising The Quality
f) Applications Of Your Company Materials In Medical
Devices & Healthcare Sectors: Regulations & Compliance Met
By Them
Medical Grade Packaging:
Quality & Compliance Requirements
a) Essential Compliances For
Medical Packaging
b) Availability Of Industry Standards
c) Qualitative Standard Rather Than The Quantitative
Standard
d) Physical, Thermal And Environmental Demands
e) Operational Qualification Of The Equipment
f) Effective Test Methods For Evaluation
g) Top Priorities While Labeling
h) Services Provided By Your Company.
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