The objective of this paper is to have the overview of packaging material when developing a sterile barrier system for medical devices packaging. There are critical qualities to be considered in choosing the packaging and qualification of sterile barrier system (SBS). Packaging is not typically at the forefront of manufacturing, but is an extremely significant component to the overall marketability and durability of a product. Medical device manufacturing is no different. In fact, without appropriate packaging, a huge risk is posed to the patients’ health, with the likelihood of an infection or in the worst case, even death. With such risks involved, it is evident why medical device manufacturing is among the highest regulated for packaging.

Apart from the main reason being patient health, effective and suitable packaging is a large contributor to the overall success of a company. When a high volume of products is permitted to be manufactured, a single FDA recall related to medical packaging can possibly cost the company millions of dollars. An instance in which thousands of medical device products are recalled caused by faulty packaging affects current revenue for a medical company; it also impacts the overall reputation of the company in healthcare industry. The paper here presents an overview of the medical packaging material selection process, with specific emphasis on the unique requirements of medical applications. Download to read more