An essential function of a sterile barrier system (SBS) is to prevent nosocomial and healthcare-associated infection (HAI). With increased awareness of health and operations safety, the global medical system has formulated stricter regulations for SBS materials selection.
In general, medical devices can be divided into “durable” and “disposable.” No matter the type, choosing the right SBS for your products is necessary. The choice of medical packaging needs to consider various important factors, including the device’s size, sterilization type, and transportation requirements, to name a few. In this article, we focus on the usage and delivery scenarios and discuss what you should consider during the materials selection stage.
To maintain the sterility of medical devices throughout production to operation, you should consider the following :
1. How to pack
At this stage, customers should consider what is being packaged, including the type, shape, and quantity of the loaded device as well as how the medical device will be used. Based on the situation at hand, the most appropriate packaging solution can then be advised, whether it be rolls, pouches, packaging machines, and so on.
2. Packaging size
Under current regulations, there is no stipulation for the number of medical devices allowed in sterilized packaging. Packaging that is too small or too large can lead to failure of the sterile barrier, especially during transportation. Therefore, space for sterilization, the weight of the medical device, and the operations scenario for end-users all need to be considered. We would recommend not exceeding 80% of the space of the packaging bag.
3. Type of packaging materials to be used
Materials selection is more complex, as more varieties need to be considered. These include:
● Is the product sharp, any sharp or rough edges?
● Does the package need isolation from water, gas, or light?
● Does the package need any special microbial barrier, or biocompatibility/ toxicology, etc.?
During packaging design and materials selection, the sterilization method and the delivery and storage conditions must also be considered.
At SIGMA, we consistently deliver high-quality products and provide insights to assist customers in packaging development. Our sterile barrier system materials meet the requirements of ISO11607 and EN868.
Stay tuned for our upcoming article where we will continue the discussion on the impact of post-sterilization processing as well as toxicological and biological considerations for materials selection.