A bar code is an optical machine-readable representation of data relating to the object to which it is attached. The code uses a sequence of vertical bars and spaces to represent numbers and other symbols. A bar code symbol typically consists of five parts: a quiet zone, a start character, data characters (including an optional check character), a stop character, and another quiet zone.
In 2012 the FDA established a Unique Device Identification (UDI) system which adequately identifies medical devices and packaging components through their distribution and use. The FDA’s objectives are to reduce medical errors, simplify the integration of device use information into data systems and to provide more rapid identification of medical devices with adverse events. This all stemmed from the 492,000 adverse reports to the FDA from 2005-2009 that pertained to improper tracking of medical devices and packaging components. The UDI states that packaging components must identify one or more of the following:
- Lot or batch number
- Serial number
- Expiration date
- Manufacture data
Now that you know of the importance of bar coding, let’s get into the different types of bar codes. The four most common types are 1-D linear, 2-D matrix, postal codes and stacked linear bar codes. Within the life science industry the most common of the four is 2-D matrix due to the fact that the matrix code improves readability and can include redundant data so even if one or more cells are damaged, the code is still readable. When it comes to 2-D matrix type bar codes there are several techniques in which they are applied. However, in the life science industry the most common is known as “Direct Mark” due to its resistance to environmental conditions and chemical exposure. Direct marks come in three main forms which are laser marked, laser etched and fired onto ceramic patch. The selection is mainly due to the chemical characteristics of the packaging component. For example, plastic vials are laser marked while glass vials are laser etched. The fired onto ceramic patch direct marking can be applied to plastic or glass but is mainly placed on the bottom of the packaging component. Now that you have essential bar coding knowledge, make sure you comply with the FDA and utilize WHEATON for your bar coding needs!