What is sterile packaging and when is it used?
Single-use medical technology devices are often required to remain sterile until use in healthcare or by the patient. This places great demands on the packaging, which must not only protect the product against mechanical damage during transport and handling, but also act as a barrier against microbiological contamination. While the packaging must have good barrier properties, it must also be permeable to various sterilisation media such as ethylene oxide gas and ionising radiation.
Sterile packaging therefore usually consists of a thick plastic film combined with a paper-like plastic film that is permeable to gases, often called Tyvek™ (DuPont) after the first commercially available product.
Possible sterile packaging solutions
Every project has its unique challenges when it comes to an optimal packaging solution. Everything from requirements for permissible external effects, user-friendliness, packaging efficiency (size) to sterilisation method and production volumes must be considered. However, in principle there are three basic solutions:
- Manual packaging in standard bags sealed by welding.
- Manual packaging in preformed hard or soft blisters where sealing takes place by welding in a permeable plastic film in generic sealing equipment.
- Fully automatic packaging during the process where a robotic solution places the product in moulded hard or soft blisters, after which the package is sealed with Tyvek.
In order to avoid misunderstanding, it’s important to emphasise that while AMB produces this type of product in cleanrooms, the products do not leave our process sterile. We do the groundwork, but sterility is not achieved until after the product undergoes a sterilisation process, which is the next step after packaging. The majority of available sterilisation processes are governed by strict safety and environmental standards, which means sterilisation competence is concentrated to highly specialised companies. AMB has established partnerships with a number of suppliers in Europe to meet various sterilisation requirements.