The importance of sterilization of rigid blister packaging for medical devices is the most basic element in terms of materials, environment, temperature, Tyvek, etc. First of all, we must understand the main functions and functions of the following sterile medical device packaging:
(1) Provide microbial barrier and physical protection
(2) Must be suitable for sterilization
(3) Maintain sterility and integrity until it is used
(4) Easy to open and sterile delivery
(5) Identify products, clearly indicate information and warnings
When sterilization methods such as ethylene oxide, steam or low-temperature oxidation are used for medical devices, the blister packaging material for sterile medical devices must have a breathable part” is clearly required by the sterile medical packaging standards.
The main reasons for this requirement are:
(1) Enable the sterilizing agent to enter the medical device packaging to kill microorganisms-to ensure the effective realization of sterilization.
(2) Enable the sterilization gas to escape from the package and reduce the residual concentration-to ensure the safety of medical staff and patients.
Especially in terms of ethylene oxide residues, because it involves the safety of medical devices and doctors and patients, the State Food and Drug Administration has strict requirements for ethylene oxide residues on medical devices that are sterilized by ethylene oxide. And often conduct special supervision and random inspections. Choosing a sterile packaging material with good air permeability and antibacterial properties is very important to ensure the effectiveness and safety of ethylene oxide sterilization.
Post time: Sep-14-2021