Our 21st Year of Publication
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Cover Story

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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