Medical Device Packaging Equipment

Medical device packaging must allow its contents to be sterilized and then must maintain that sterility until the time of use all while optimally balancing the multitude of considerations that are part of the package development process.

Medical device packaging equipment.

Medical device packaging validation varies greatly depending on the risk policy of the medical device manufacturer as well as the class of medical device. Labeling regulations pertaining to medical devices are found in the following parts of title 21 of the code of federal regulations cfr. Packaging for terminally sterilized medical devices published in 2006 is the principal reference guide for medical device packaging and includes information on testing requirements. The medical device market is right in the sweet spot of making the most of our expertise in compliance and our turnkey solutions in packaging systems.

From dental devices to post partum medical supplies viking masek has a flexible packaging solution to increase your production and provide high accuracy in accordance with your package filling specifications. The package of a medical device will play a fundamental role in the safe delivery of treatment to patients. Astm and ista series distribution testing offer a set of specific test methods for compliance with iso 11607. Typical distribution simulation for medical devices is defined in astm d4169 standard practice for performance testing of shipping containers and systems dc 13.

Flexible packaging machines for medical supplies. This article is in follow up to sterilization methods for medical device packaging packaging insights newsletter july 25 2016. 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. Poor packaging can cause a host of problems for medical device companies and their customers.

General device labeling 21 cfr part 801 use of symbols. Testing intensity is determined based on the specific device and system. Neil thompson is business development manager of steriliant llc a one stop shop for medical device companies packaging needs. Flexible packaging in the medical industry is a rapidly growing and changing market.

Thomas packaging has spent more than 50 years optimizing packaging equipment for the needs of multiple industries.