Do you understand the "expiration date" of medical device sterilization packaging?
In daily communication, we have found that there are some misunderstandings regarding the "expiration date" of sterile packaging. What is the relationship between the expiration date of the packaging and that of the product? Let's discuss this topic today, hoping to assist you in better supply chain management and product validation.
Conclusion first:
The expiration date of the packaging is not equal to the sterility expiration date of the product.
Let's clarify the concepts of these two together.
Expiration date of the packaging
The shelf life of packaging refers to the shelf life of unused empty packaging under specified storage conditions. It is usually concluded by the packaging supplier after conducting accelerated aging and real-time aging tests on the sterilized packaging products.
Within the validity period, it can ensure the stability of the sterilization packaging performance, preventing issues such as edge cracking, significant reduction in peeling strength, and deterioration of the physical properties of materials that could affect the quality of the packaging itself.
The shelf life of the packaging usually starts from the completion of the finished product production.
Sterile expiration date
The sterile validity period refers to the time during which a medical device product can maintain its sterile state after packaging, sealing, and undergoing sterilization treatment, under specified storage conditions. This is a key piece of information that must be indicated when the final product is marketed.
There are many factors that affect the sterile barrier system.
Material Selection:
Appropriate packaging materials and packaging forms.
Sealing process:
Sealing equipment's process parameters, proficiency of the operators.
Sterilization process:
The impact of sterilization methods, loading and stacking methods, sterilization duration, and changes in pressure and temperature during the sterilization process on the sealing of packaging.
Transportation and Storage:
Handling during transportation, bumps, pressure changes; temperature and humidity of the storage environment, etc.
Only through system sterilization validation, transportation testing, and aging validation can the sterile shelf life of the entire medical device product be determined.
Sure, here's the translation: "Small question:"
Can double-layer packaging extend the sterile shelf life?
The answer is no.The sterile validity period depends on the antibacterial properties of the material and the integrity of the sealing. Increasing the number of packaging layers may help enhance physical protection to prevent punctures or abrasion during handling, but it does not change the aging performance of the seal, so it cannot be directly equated with an extension of the sterile validity period.
When using gas sterilization, attention should also be paid to the breathability effect of double-layer packaging and the resolution efficiency.
It is recommended that you choose the packaging materials and forms according to product requirements. Refine the management of packaging material inventory in production planning, adhere to the "first in, first out" principle to avoid excessive accumulation leading to material expiration, thereby reducing unnecessary losses.
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