It’s not uncommon to have a process in your business that may be affected by any number of standards. Luckily, there are various guidance documents that can help you choose among the many options to find the best solution for your situation. The ASTM F2097, “Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products,” in one such standard. It’s just been updated this month and the new edition is available at Document Center now.
When will you use this guide? As early in your process as possible! After all, changes during design are cheap compared with changes later on down the road. And the ASTM F2097 is meant to be used during the design and evaluation phase of product packaging development. It’s a compilation of the various test methods, practices and procedures you might want to use.
Multiple categories for evaluating flexible medical packages and materials are described. You’ll get information on the following:
- safety
- barrier properties
- durability
- package and seal integrity
- visibility and appearance
- processing
- the properties of printing ink
- packaging performance
You won’t get information on sterilization. It also doesn’t cover acceptability criteria (which should be determined jointly by you and your package producer).
How does this happen? The categories are sub-divided into various properties and standards for each of the sub-divisions are detailed. This will give you a way to sort through the properties you need to have for your product, leading to the various standards options you then have. There’s a table that helps you find your solutions, then a section that reviews the coverage of each possible standards choice and the applicability of each.
The main focus of this update is to add a number of new referenced standards to the guide. Most of the new additions are released by ASTM. You’ll also notice that a number of referenced standards are now withdrawn, but still available if required.
Next, you’ll want to know how you can get a copy of this new release. Document Center Inc. has been an authorized dealer of the ASTM standards since the 1980’s. You’ll use our website, www.document-center.com, to search for and order the standards you need. Or you can contact our staff via phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). Not only will you get notifications of future changes to the documents you purchase from us, but you can check to see if your copies are still current at any time just by registering on our site.
Document Center works hard to provide you with the tools and services you need to keep your compliance documentation current. Make us your Standards Experts!
