Medical Pouch Sealing
Medical pouch sealing is a process that is used within the medical device and life science industries for packaging medical products that require sterilization. The process involves two main components: a medical pouch and a medical grade heat sealer.
A medical pouch is a flexible package consisting of laminated or mono-layer flexible materials including but not limited to Tyvek®, coated foil, film, and coated paper. The pouch is created by bringing two webs of material together and sealing them on three sides, leaving the fourth side open. The product is inserted into the pouch and then it is heat sealed across the fourth and final side to create a sealed package in preparation for sterilization.
The heat sealer used in this process must be a medical grade sealing system that provides accurate and repeatable control over temperature, pressure and seal time. In addition, the system should include process alarms and features to prevent the operator from modifying the validated settings, and the heat sealer should be ISO 11607 compliant, cleanroom compliant and able to be validated and calibrated.
Because medical packaging is so critical for keeping medical and life science products free from contamination, medical pouches are considered part of the product delivery system. When a medical device manufacturer is designing a package, they qualify the package along with the product because the product is not considered usable unless it can arrive at its ultimate destination as a sterile product. So, the sterile barrier system is the package, and in most cases, the package is part of the product, because the product cannot be used without proper packaging.
Medical pouch sealing is used for a variety of items that need to be kept sterile
Manufacturers use medical pouches to package a wide range of high value products used in health care and the life sciences. For example, medical pouches are used to package single use disposable devices, such as catheter delivery systems. . In addition, medical pouches can be used for devices that ultimately become a permanent part of a patient’s anatomy, such as stents, the components used for hip replacements and the screws and rods that can be used to repair bone fractures. Medical pouches are also used for packaging certain surgical instruments, although in many of these cases, the instrument is cleaned/reprocessed, sterilized, and packaged more than once.
Typically, medical pouches are not used for lower value medical products, such as gauze or bandages. They are used mostly to package medium or high value, low volume medical products.