Product Classification System
As a part of our new catalog number initiative, “general use” products will also receive a Classification so that customers are aware of the manufacturing level of the product. We anticipate that this will be of most help to manufacturers of commercial microparticle reagents. These types of products will receive one of the following classifications:
I. Validated Products
Manufacturing process with documented evidence that the process consistently yields a product with results that meet predetermined specifications and quality attributes. Manufacturing processes have been validated through the ISO 13485 Design and Development process.
II. Standard Products
Manufacturing process yields a product with results that meet predetermined specifications and quality attributes. Products and processes are not validated but are capable of being reproduced. Material is produced with validated equipment and test methods under ISO 13485 guidelines.
III. Supported Research Products
R&D manufacturing processes are conducted in accordance with established techniques, but may have some differences in formulation and/or the overall production process, as compared to Validated and Standard products. Manufacturing processes are documented, and may be repeated on a custom basis as needed.
IV. Unsupported Research Products
R&D manufacturing processes are conducted in accordance with established techniques, and have undergone basic characterization. Bangs has not made an effort to validate or reproduce the product.