After the medical mask is produced through a series of processes, it needs to complete the "release" step before it can be used normally on the market. The most time-consuming requirements for release are sterility testing and analysis of ethylene oxide. Let's explain in detail the two release requirements.
1. About sterilization release
At present, the more popular aseptic release method in China is to perform sterility test according to the sterility test method of the Chinese Pharmacopoeia. The so-called sterility test is to take a sample after sterilization, and check whether the product is free by membrane filtration method or direct inoculation method. bacteria. It is explicitly stated in this method that a 14-day incubation period is required to determine whether the product is ultimately sterile. In other words, the medical surgical masks produced on the first day of the New Year's Day, even if the sterilization test can be completed on the day, it will not be determined until the Lantern Festival that the batch of masks can be shipped.
Second, about EO residue
As long as EO is used for sterilization, the influence of EO residue must be considered. On October 27, 2017, the International Agency for Research on Cancer of the World Health Organization published a list of carcinogens, and ethylene oxide was on the list of carcinogens. EO is a central nervous system inhibitor, stimulant, and protoplasmic poison. A small amount of contact for a long time shows neurasthenia syndrome and autonomic dysfunction. Therefore its limit must be controlled very strictly.
At present, the three standards of medical protective masks (GB 19083-2010), medical surgical masks (YY 0469-2011), and disposable medical masks (YYT 0969-2013) stipulate that the EO residual amount cannot exceed 10 μg / g. In fact, the domestic requirements are already very strict. By contrast, the international standard ISO 10993-7 does not exceed 4 mg / piece. According to the general mask 3-4g / piece, the heaviest can generally reach 10g / piece, according to the requirements of domestic standards calculated as 40-100μg / piece, the international standard is 40-100 times the domestic standard.
On the one hand, domestic requirements are stricter. On the other hand, to achieve release standards as soon as possible after EO sterilization, EO analysis of sterilized products is required. The main problem of EO analysis is the primary packaging materials of medical masks. At present, the packaging materials of most masks on the market are plastic bags, and plastic itself is a gas-tight packaging. The EO analysis under this packaging material takes longer (usually 7-14 days).
So how can we effectively speed up the release of products in response to this urgent use demand?
Thermoformed packaging is usually done by ZY AUTOMATION DPXB-B model thermoforming packaging machine and fabricated from plastic, Tyvek, foil, paper, polyethylene, polypropylene, or laminates of these materials and sealed to form peel-open or tear-open packages. New packaging materials continue to come onto the market, including polyester/polyester combinations and linear low-density polyethylene. The integrity of the pouch, and its sealing, is one of the most important steps in medical device manufacturing.