Medical device packaging importance

 

Medical device packaging importance states the packaging of medical devices frequently takes place in a clean room, and the packaged devices normally undergo some kind of sterilization. But it is the role of packaging to keep the device sterile right up until use. The correct selection of packaging, therefore, is a crucial but complex decision, and statistics suggest it is often not carried out correctly. 

Medical device packaging importance is a crucial part of the industry with its own separate set of safety and security concerns, for good reason. Packaging serves a number of purposes. It not only protects a product from harm or tampering during transit but can display critical product information and brand marketing. 

• Operon Strategist provides worldwide packaging consultants services to the primary packaging and pharma industries, including strategic, regulatory and environmental compliance.   

Medical device packaging importance is in a class all of its own, due to the important equipment it carries. This makes safety and security measures top priority for this type of packaging. 10% of medical device recalls are attributable to packaging failures and 31% of those are due to a hole in the packaging.

Medical Packaging Standards 

An overview of the current status of the relevant medical packaging standards ISO 11607-1 is the most important. It states that medical device packaging should be:

• Made of known and traceable materials
• Non-toxic, non-leaching and odorless
• Free of holes, cracks, tears, creases and localized thinning
• Intended for use in medical applications.

It must also:

• Allow sterilization
• Provide physical protection
• Maintain sterility up to the point of use
• Allow aseptic presentation.

The packaging is a highly significant part of the medical device market with its own separate set of security and concerns for safety reasons of the consumers. The packaging carries out a number of purposes, not only it protects the product from contamination or harm, but also displays crucial products information and does brand marketing.

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