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Individuals responsible for medical packaging system design and validation are required to provide a safe and effective packaging system that can deliver the enclosed product to the end-user without incurring defect or risk to patient safety.
For manufacturers of terminally sterilized medical devices, compliance to ISO 11607:2006 –“Packaging for Terminally sterilized medical devices”---Part 1 and Part 2 is a requirement. A published tool to guide and assist you in compliance with ISO 11607 is AAMI TIR 22. TIR 22 is a technical information report published by AAMI for compliance assistance. It is not a balloted standard but is reviewed by an AAMI technical committee. The focus of this article is to provide those responsible for medical device packaging system design with some key best practices and insights for the design and development of the medical packaging system. We do not address Part 2, equipment and process validation.
The following seven essentials are not comprehensive however, if they are ignored, a successful package design is at risk or delayed in the ever critical time to market.
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Click here to read all 7 Essentials for Successful Medical Package Design
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DDL's knowledge Center is a resource for medical device manufactures to utilitze in times when questions arise about their package testing projects. DDL's educational resources include white papers written by industry professionals, helpful hits, steps to compliance and quick tips on getting your product to market on time while also maintaining the efficacy of your product.
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12 Essential Steps to Deliver Your Medical Device Packaging System to the Clinical Site or the Marketplace
Essential #1: Packaging Design Requirements
It’s imperative to define the packaging system in order to proceed with development and implementation. The packaging engineer/designer must collaborate with the relevant project team members to create a packaging design requirements document which provides a clear expectation of the function, limitations, special features, aesthetics, product/company branding, cost limitations, size limitations, sterilization method, labeling requirements, hospital/clinic storage requirements, case count and possible adverse conditions of use and/or distribution and storage
Essential #2: Packaging System Hazard Analysis
The goal of a thorough packaging system hazard analysis is to eliminate all high severity hazards and reduce as many medium and low severity hazards as possible. Two prime high severity hazards are breach of the sterile barrier (for sterile barrier package) and damage to the medical device which is not easily detectable and may impact the safe and effective use of the device.
In summary, perform a packaging system hazard analysis early on after the package design requirements have been established to ensure patient safety through product and package safety and efficacy.
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Click here for all 12 Steps to Deliver your Medical Device Packaging System to the Marketplace!
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Emphasis on Testing: How to Work Successfully With a Package Testing Lab
Many medical device packaging manufacturers struggle to understand what they need to do to test and certify their packages. Here are 10 tips to help you work efficiently and effectively with a third-party package testing lab in order to satisfy your package testing expectations and regulatory requirements.
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Click here to read all 10 tips on how to sucessfully work with a package testing lab.
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