1 There is a problem
The commonly used medical plastic bottle material is low density polyethylene (LDPE; PE-FAS-18D022). Because the country still lacks a unified quality standard for the quality control of plastic bottles, the quality of the products is uneven and extremely unstable, and there are mainly the following aspects.
1.1 The bottle volume scale and thickness is not consistent with the standard 100 ml plastic bottle, actually only 95 ml in the cylinder operation; and 8 ml plastic eye drops bottle, has not been verified to meet the requirements. Thickness of plastic bottles (by weight) Medical standards: 16.5 g for 200 ml, 9.3 g for 100 ml, 7.0 g for 60 ml, and 2.0 g for 8 ml. We randomly selected some 100 ml samples for comparison and found that the actual weighing of the plastic bottles produced by several factories was only about 7.8 g.
1.2 The use of recycled plastics in factories is not only harmful to human health, but also affects the smoothness and transparency of plastic bottles, which in turn affects the quality control of the preparations. For example: affect the clarity of eye drops, etc.
1.3 The plastic bottle mouth is not round and it is not matched with the lid. Filling the bottle with the drug preparation will affect the drug content and the preservation time of the preparation.
1.4 Hygiene inspection does not meet the requirements The inner and outer walls of plastic bottles are frequently heavily contaminated, and impurities often appear in the bottles, such as bugs, broken plastic sheets, and so on. At present, common preparations of many units are directly filled with plastic bottles. Due to the fact that the bottles were not cleaned and disinfected before use, even the freshly prepared preparations did not meet the requirements through hygiene inspection. In our hospital, there has been a failure of hygienic examination of a mixture of belladonna and after analysis, which was caused by the quality of the bottle.
1.5 Plastic bottles do not meet the requirements of some manufacturers did not double plastic bottle packaging, and even appear directly with urea bags.
2 Improvement measures
2.1 Strictly control the purchase of the plastic bottle under the premise of other conditions are in line with the provisions of the requirements, the selection of plastic bottles should pay attention to the following points:
2.1.1 Cover lid and bottle mouth should be tight, inside the cover should have a spiral, play inside plug.
2.1.2 The packaging bottle and bottle cap should be packaged together and double outer packaging should be used. In order to achieve dust, moisture, anti-pollution effect.
2.1.3 Leakage test Randomly take the plastic bottles produced by various manufacturers, place them in clean water, and gently hold them by hand. Observe whether there is a bubble overflow and whether or not clear water enters. If not, it indicates that the bottle has good sealing performance.
2.2 Strictly disinfected plastic bottles can be sterilized by the circulation steam method. Experiments confirmed that plastic bottles were sterilized by steam at 100Â°C for 30 minutes. After hygiene tests, pathogenic bacteria, bacteria, and live fleas were all negative and the bottles were not deformed. This method works well, but when sterilizing, it is necessary to pay attention to opening the bottle and the lid must be sterilized at the same time. Plastic bottles can also be processed by other methods. If it is swabbed with 75% ethanol or soaked with 0.1% virgin for 30 minutes, rinse with fresh distilled water and drain.
In summary, the author proposes to formulate a uniform quality standard for the plastic bottles of the formulations. All medical units should strictly control the purchase and disinfection of plastic bottles and eliminate the use of inferior products in clinical practice.
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