Medical Plastic Data Service Magazine



Our 30th Year of Publication
Page  4 of 5

Cover Story



Mr. Sanjay Shah
Unikal Consultants

This article covers basics of packaging material regulatory requirements for medical device packaging and how to evaluate the vendor.

Technical information for specifications is based on the EN ISO standards and FDA guidelines. The requirements for Indian Medical Device regulations are based mostly on EU guidelines. In preparing the article, author has referred to various standard requirements, vendor evaluation based on ISO 13485 and online search. I have interpreted some of the requirements based on my years of experience as regulatory consultant for medical device manufacturing facilities.

In present scenario, definition of medical device and regulatory requirements are well understood across the board. The same is not repeated here. Need for extensive medical device regulations world over and specifically for India is well justified, my views on the same, some other time.


Packaging needs are outlined and clearly defined in the Indian context and are described in MDR. Even then, need for vendor (packaging manufacturer & distributor) evaluation and basic need to comply to ISO 13485 requirements and compliance are not understood, even not found necessary. Why so?


The answer lies in the fact that packaging was not considered very critical. Even sterile barrier packaging was thought of as manufacturer assured. Now requirements for ISO 11607-1 & 2 have been applicable for packaging material.


ISO 11607 are primary standards, which medical device packaging should meet, viz. it should be made of known and traceable materials; non-toxic, non-leaching and odorless. Free of holes, cracks, tears, creases, and localized thinning. The standard outlines basic requirements for sterilized medical device packaging. Sspecifically, the standard identifies two parts:

  • The sterile barrier system (SBS), which protects and “minimizes the risk of ingress of microorganisms and allows aseptic presentation of the sterile contents at the point of use”

  • Protective packaging, an additional layer which protects the sterile barrier system.

Together, these elements form the packaging system, and maintaining its integrity is paramount to safety. However, one study found that 10% of all medical device recalls were caused by packaging failures, with 31% of those occurring due to a hole in the packaging system.


Needs for packaging requirements are part of design development [ISO 13485’s clauses 7.3.3 a, b and usability file], but it was not taken seriously, to say the list. If you asked people what comes to mind when you say designing a medical device, you’re likely going to have responses related to design controls or the device itself. What one is not likely to hear is packaging or labelling.


Device manufacturers will need to consider the design and functionality of the device: the specific nature of the medical device. Some specific areas to address are:


• What are the intended sterilization methods?
• What is its intended use?
• Where will it be used?
• Who are the end-users?
• How will it be transported?
• How will it be stored and for how long?
• What is the device expiration date?


In that scenario, to understand need for primary & secondary & outer packaging (box & carton & shipping), was not even thought necessary. Evaluation process was, we will go for trial & error method. If box breaks, user will complain, and we will at the most replace the box, then we will re-design the packaging. Thought of validation was difficult to come in the mind.


What is the Impact of packaging to the device? It protects, preserves and act as barrier if device is sterilized or to be used after sterilization. Risk benefit analysis of the packaging should be always a part of the CER.


Concept of damage, improper labeling, or partial damage to the information available was not thought very critically. “Refer clause 7.5.11 and specifically clause a) designing and constructing suitable packaging and shipping containers”


What does ISO 13485 (now accepted world over as a gold standard) say? It is very clearly defined as referred above.


Still, it seems that one of the last things on one’s mind, when designing a medical device is how one is going to package it. More often than not, it’s because people underestimate what it takes to design and test the packaging. Thus packaging design process is all too often given little attention in the overall product development process. But with so much riding on the packaging process & designing decisions at hand, manufacturers cannot risk letting packaging become some sort of afterthought.


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