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Medical Device Packaging
With the growth of the Medical Device Industry, the need for Sterilizable
Packaging , Barrier Packaging , and other packaging requirements for medical
devices is increasing . The performance and regulatory requirements makes it
essential for medical device manufacturers, packaging converters and material
suppliers to be aware of important packaging issues involving both design and
manufacture.
Medical Device Packaging Failures have been the most important issue. It
has a major contribution towards sterility of the product and is considered to
be the major source for Sterility recalls.
Packaging Material Suppliers, Converters, Medical Device Manufacturers, Service
Providers including Sterility and Quality Assurance Experts as well as Medical
Packaging and Testing Equipment Manufacturers need to work closely to prevent
“gross” packaging failures and to meet global regulatory requirements.. |
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Over the last few years , Medical Device Packaging has become more interactive
and will continue to be more communicative in the time to come.
This issue focuses on various critical aspects related to Medical Packaging .
The lead article by Dr R Rangaprasad, Business Head, Packaging 360,
highlights key considerations starting from Design to testing processes
including required quality and regulatory standards. As has been rightly
emphasised by Dr Rangaprasad , “Medical device packaging doesn’t 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 altered “.
Another very important article on “Vendor Evaluation by Medical Device
Manufacturers" , Mr Sanjay Shah , CEO, Unikal Consultants has explained the
essential aspects of vendor evaluation process as per ISO 13485 requirements. As
also rightly mentioned by Mr Sanjay Shah , Packaging needs are outlined and
clearly defined and described in the Indian context in the Medical Device Rules.
It is estimated that more than one million tons of clean, non-infectious
healthcare plastic waste is generated in healthcare facilities each year
according to “The Healthcare Plastics Recycling Council ( HPRC ) . One area
where there is an opportunity to reduce waste through increased innovation and
process and material optimisation is in healthcare packaging.
This issue also highlights some of the misconceptions about Medical Device
Packaging.
Biomaterial Basics : Introducing Biocompatibility and Bio stability
A detailed technical article by the company, “ Lubrizol” defines
biocompatibility and bio stability for medical polymers and explains “why both
matter to patient health and comfort and provides examples of how performance
properties of commonly used polymers determine what devices in which they may be
successfully be used”.
In our regular column on “Global Markets" , Mr Amit Shah explains how
various global regulatory authorities are classifying Medical Devices in their
countries.
This issue covers our regular columns including Regulatory , Industry & Industry
Association News , Global Trends, Events and more...
D.L. Pandya
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