Medical packaging validating 1 year of online dating at 50

10-Sep-2015 01:55

A primary purpose of a package is to ensure the safety of a product during transportation and storage.

If a product is damaged during this process, then the package has failed to accomplish a primary objective and the customer will either return the product or be unlikely to purchase the product altogether.

The degree of package testing can often be a business decision.

Risk management may involve factors such as With distribution packaging, one vital packaging development consideration is to determine if a packaged-product is likely to be damaged in the process of getting to the final customer.

Consequently, medical device manufacturers should perform appropriate validation studies in order to justify shelf life and transport stability of their devices.

This includes also the validation of the packaging processes, like forming and sealing process of sterile barrier systems, pursuant to ISO 11607-2.

Afterwards, the products can be subjected to the various test systems in order to evaluate the performance of the packaging system (aseptic presentation and microbial barrier properties) as well as the performance of the containing medical device (functionality and biocompatibility).

We will not only provide the test data , but we will interpret the data and provide conclusions, which can be used as part of a submission to your notifying body.

According to ISO 11607-1, the specific properties of medical devices and their packaging systems must remain stable during their shelf life.

The need for validation is an integral part of the medical device industry and Nelipak understand the demands put on any business by the work involved in validating both devices and equipment.

Nelipak offers a comprehensive range of services specifically providing support to your package testing and validation requirements.

Afterwards, the products can be subjected to the various test systems in order to evaluate the performance of the packaging system (aseptic presentation and microbial barrier properties) as well as the performance of the containing medical device (functionality and biocompatibility).We will not only provide the test data , but we will interpret the data and provide conclusions, which can be used as part of a submission to your notifying body.According to ISO 11607-1, the specific properties of medical devices and their packaging systems must remain stable during their shelf life.The need for validation is an integral part of the medical device industry and Nelipak understand the demands put on any business by the work involved in validating both devices and equipment.Nelipak offers a comprehensive range of services specifically providing support to your package testing and validation requirements.Many have certifications and accreditations: ISO 9000, ISO/IEC 17025, and various governing agencies.