Medical Device Packaging Ppt

Most medical devices are packaged either in a pouch or a tray.

Medical device packaging ppt.

Medical device packaging design is an integral part of delivering your device to market safely and securely with the sterile barrier intact. Most single use sterile medical devices can be opened with a high degree of confidence that the. Yet this critical process is often given little attention in the overall product development process. Here is a breakdown of the design sterilization testing requirements and validation processes medical device companies need to consider when tackling a packaging project.

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. When sterile medical devices are involved deficient packaging can cause the following problems. 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. 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.

The package of a medical device will play a fundamental role in the safe delivery of treatment to patients. Seal strength also allows the medical device manufacturer to confirm the reproducibility of their sealing process and adherence to design specifications. If not properly planned for upfront packaging can significantly delay timelines. Poor packaging can cause a host of problems for medical device companies and their customers.

D c act. Packaging strength is important to show that the package protecting the product is strong enough to contain the product system after distribution or aging. Packaging is too often neglected as an important characteristic of a medical device. 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.