Medical Device packages supplied for use already sterile have a very important function, which is to serve as a sterile barrier. That is: in addition to the natural function of protecting the product against shocks during transport and contributing to the stability of its functional properties, they also need to maintain the sterility of the product.
Maintaining this sterile barrier depends on three main factors: choosing a packaging technology that is capable of forming this barrier, maintaining the integrity of the package, and maintaining the seal of the package.
Over time, and depending on storage conditions, the packaging or its sealing may deteriorate, compromising the sterile barrier. Thus, it can be said that there will be a maximum time (shelf-life) in which it is proved that the product remains sterile.
More humidity and higher temperature tend to deteriorate packaging material more quickly. Thus, the storage conditions defined by the manufacturer must take into account maximum values of humidity and temperature, which will influence the shelf life. It is a choice between restricting storage conditions and having a longer shelf life, or flexing storage conditions at the cost of a shorter shelf life.
To validate this maximum time, it is not necessary, at first, to age the product in real time within the critical conditions established for storage. There are protocols for accelerated aging, where the temperature and humidity conditions defined as input data for the project are taken as a basis, and thus a maximum shelf life is defined within the specified storage conditions.
Here is a valuable tip: do not let the laboratory define its validity and storage condition for you. If you are contracting a stability or shelf-life study and the laboratory has not asked about your storage condition, think twice. Ask. Each company has a logistics chain and distributors with specific needs. It is important to take this into account when defining the accelerated aging protocol. It is common for some laboratories to define “European” aging protocols, which greatly restrict the storage condition, without taking into account the logistical difficulties encountered in Brazil.
If you have any questions, we have a team of experts in validation and verification of projects in the field of medical devices. Make contact with us!
TIP: In addition to validating the packaging against storage conditions, it is also relevant to validate the packaging against storage conditions. transport. There are road, air and sea transport simulation protocols that impose possible shocks and falls to the product inside the package, and that provide important data for product quality assurance.
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