Medical Device Packaging Ppt

A package that holds a sterile medical device not only has to arrive at the hospital or clinic free of holes tears and broken seals it also has to withstand sitting on a shelf possibly for years without breaking down.

Medical device packaging ppt. The importance of packaging to the implementation of a medical device is illustrated in a speech by george brdlik in 1982 that is no less true today. Introduction a medical device is an instrument apparatus in vitro reagent implant or other similar or related article which is intended for use in the diagnosis of disease or other condition or in the cure mitigation treatment or prevention of disease or intended to affect the structure or any function of the body and which does not achieve any. Poor packaging can cause a host of problems for medical device companies and their customers. Seal strength also allows the medical device manufacturer to confirm the reproducibility of their sealing process and adherence to design specifications.

Most single use sterile medical devices can be opened with a high degree of confidence that the. When sterile medical devices are involved deficient packaging can cause the following problems. The package of a medical device will play a fundamental role in the safe delivery of treatment to patients. Lockhart s utility function encompasses a diverse array of basic functions such as containment and other added value features for example allowing aseptic presentation in medical device packaging.

Medical device packaging design is an integral part of delivering your device to market safely and securely with the sterile barrier intact. Here is a breakdown of the design sterilization testing requirements and validation processes medical device companies need to consider when tackling a packaging project. Packaging strength is important to show that the package protecting the product is strong enough to contain the product system after distribution or aging. Most medical devices are packaged either in a pouch or a tray.

Yet this critical process is often given little attention in the overall product development process. It needs to ensure the integrity of the product from the manufacturer to its final point of use and in some cases the packaging could function in the treatment application. An outlook on medical device packaging market growth is presented in this latest research report that reviews industry growth drivers trends regional factors companies as well as provides forecasts for next few years. If not properly planned for upfront packaging can significantly delay timelines.