Developing a successful stability and compatibility program is a critical part of the packaging process. Failures in stability and compatibility can doom a project, but the proper program can ensure success and avoid the black hole.
After the package has been designed, make sure you understand the specific handling requirements of the products, how it is being used and what type of container it is going into. Then, follow these six steps.
1. Determine a clear set of goals for what tests you want to put the product through in order to determine stability and compatibility.
2. Create a document that outlines the testing protocols.
3. Develop more than one type of material to test. Testing multiple materials is an important insurance policy. If one or more of the options fail, you have backups and do not have to start from scratch. By testing three or more materials, you can be confident that at least one, if not more, will work.
4. Produce a pilot run of sample product to send to the testing lab for evaluation.
5. Once you achieve a positive outcome, outline the production requirements.
6. If your product is an over-the-counter or prescription drug, develop a protocol and then execute three consecutive runs (validation batches) as required by the FDA.
By following these steps, your program will include the documentation and variety of materials needed to avoid the black hole. Oftentimes, when companies start stability and compatibility programs, they only use one or two types of materials. In the event that test results are not positive, more testing will have to be done causing a great loss of time and momentum for the project.
With a testing process that normally takes 90 days, mistakes in documentation and variety selection can delay your project by three months. Do not risk these costly delays. Take the time to do it right the first time around.