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How Tray Sealers Are Validated
Statistical terms used in tray sealing: CPK and standard deviation Process capability (CPK) is a statistical measurement that describes the accuracy and repeatability of a tray sealing process. Using an archery target as a metaphor, an ideal tray sealing process is...
Creating and Testing a Hermetic Seal
Creating and testing a hermetic seal The most important elements needed to create a hermetic seal between a tray and lid are temperature, time, and pressure—and for tray sealing of medical devices, those three elements must be applied consistently, with little to no...
The Benefits of Sealed Trays and Upward Trends
The benefits of sealed trays compared to pouches and clamshells Sealed trays offer benefits that pouches and clamshell packaging cannot. The major advantage is product protection. A sealed tray protects a medical device for the entirety of its shelf life—through the...
Types of Medical Tray Sealers and Options
Types of sealers used for tray sealing medical products Among all the different types of available sealers, constant heat sealers are the best choice for tray sealing. Constant heat sealers heat up to a set point temperature and then are very stable at that...
How Sealed Trays Are Sterilized
The different types of sterilization processes used with tray sealing Tray sealing is commonly used to package medical devices that need to be shipped and stored under sterile conditions. The sterilization process happens post-packaging, i.e., after the sealed package...
The Medical Tray Sealing Process
What is the medical tray sealing process? Medical tray sealing involves applying a specific temperature for a specific amount of time under a specific pressure so that the lid and tray materials are bonded together. First, the rigid plastic tray, usually empty, is...
Tray Sealing 101
What is tray sealing? Tray sealing is a packaging process that binds a flexible, die-cut lid to a pre-formed, rigid tray that contains whatever it is that needs to be packaged. Usually, the lid is made from thin material such as Tyvek, laminated foil, paper, or film,...
How to Find the Right Vendor
How to select a vendor for heat sealers for medical pouches With so many types of heat sealers and ancillary features available today, the process of choosing for the right vendor can seem a bit daunting. Here are the key capabilities you need to look for: First, it’s...
Validating Heat Sealers
Validation of heat sealers using IQ, OQ, and PQ Heat sealers must be validated before they can be used in production. This validation is a three-phase process. The first phase is the IQ, which stands for installation qualification. During the IQ, the medical device...
