Our 30th Year of Publication

From Editor's Desk

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..

Mr. D.L. Pandya


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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