Do you have a medical device that needs sterile packaging? There are a few common challenges that people face when completing this task. There are 4 major concerns that should always be considered:
Specifications and Design
There are plenty of aspects to consider when sterile packaging your medical device. The best place to start is to decide the number of products or product lines you wish to package. This will be determined by your allotted budget. The more product lines or product sizes that you can fit into your package the better. This will dramatically drop your cost because it will reduce the number of validations required.
There is not a clear-cut most effective sterilization method. The most common sterilization methods available are gamma sterilization and ethylene oxide gas. You need to decide which method is compatible with the product and packaging materials. In the case of gamma sterilization, one must monitor the materials after sterilization. They often will change colors. In regards to ethylene oxide gas, there cannot be residual gas on your device. The bottom line is if you need to surface sterilization, gamma is your best bet. If your device has intricate surfaces you may want to select ethylene oxide.
When sterile packaging, one needs to decide if they want to use a tray or a pouch. This decision will influence the timeline of this process. Trays require more lead time than pouches because their tooling is more involved. In the case of pouches, there is not any custom equipment for sealing purposes. There are three major validations that are included in the lead time: equipment implementation, packaging validation, and sterilization validation.
This will be differ depending on whether you currently manufacture in house and have a clean room accessible. If you do, then implementation will have equipment implementation, standard operating procedures and a small restructure of the material requirements planning system. A person who does not have a manufacturing packaging facility needs to engage a packaging contract manufacturer that is ISO 13485 certified.
Advanced Packaging, Inc. for All Your Medical Case Needs
Advanced Packaging, Inc. has an incredible amount of experience making custom demo cases from a wide range of materials for a wide range of objects. We have the latest in quality assurance technology to make sure that whether you need aluminum custom casing or quality package testing for your product, we can get the job done safely, quickly, and expertly. If you would like to learn more about our custom packaging, give us a call at 1-888-206-5250 or visit us online. For more tips on picking the right custom case for you, follow us on YouTube, Flickr, LinkedIn, Facebook, Twitter, and Google+.