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.
Medical device packaging ppt.
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.
Packaging is too often neglected as an important characteristic of a medical device.
Most medical devices are packaged either in a pouch or a tray.
Packaging strength is important to show that the package protecting the product is strong enough to contain the product system after distribution or aging.
Yet this critical process is often given little attention in the overall product development process.
When sterile medical devices are involved deficient packaging can cause the following problems.
Most single use sterile medical devices can be opened with a high degree of confidence that the.
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.
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.
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.
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.
Here is a breakdown of the design sterilization testing requirements and validation processes medical device companies need to consider when tackling a packaging project.
Seal strength also allows the medical device manufacturer to confirm the reproducibility of their sealing process and adherence to design specifications.
Instrument intended for internal or external use in the diagnosis treatment mitigation or prevention of disease or disorder in human beings or animals as may be specified from time to time by the central government by notification in the official gazette after consultation with the board.
D c act.
Poor packaging can cause a host of problems for medical device companies and their customers.
