There are many types of syringe packaging products prod […]
There are many types of syringe packaging products produced by syringe printing machine. What are the quality requirements of syringe packaging? Now do the following brief analysis based on some of its characteristics:
First of all, the current syringe packaging mainly includes glass and plastic materials. The syringe packaging is gradually replacing the glass syringe. Its main cost is lower, and the safety is higher than that of the glass syringe packaging. It is not easy to break. The production process of high-quality syringe packaging products is relatively advanced. Generally speaking, injection molding is used to produce syringe packaging. The products produced by the injection molding process are formed at one time without scraps, the product size is accurate, and the weight is uniform.
Second, the sealing requirements of the syringe packaging products are relatively high. When selecting the syringe packaging products, the sealing performance should be tested. Inject half the water in the syringe, insert the piston into the syringe, remove the protective cap, and remove the residual air Then, block it with a protective cap, and apply an axial pressure of 30N on the plunger plug inside the barrel through the push rod for 30 seconds. There should be no leakage at the seal of the protective cap and the seal of the piston.
Third, because the syringe is in direct contact with the drug, its sterility must be guaranteed. Generally, the syringe package should be produced in a clean workshop that meets national standards. In addition, in order to ensure its sterility, if the manufacturer has a high sterility On request, additional ethylene oxide sterilization or cobalt 60 irradiation sterilization can be performed.
The syringe is a new type of medicine packaging container with high technical content, which is suitable for injection and injection forms. It is very convenient to combine the syringe and the medicine liquid packaging container into one, and directly inject when in use. There are strict requirements for syringe discoloration and microbial limits.
The main test methods and requirements are as follows:
Microbial Limit:
The number of bacteria is not detectable per bottle, the number of molds and yeasts is not detectable per bottle, and the number of E. coli is not detectable per bottle.
Decolorization experiment:
Take three groups of 4g test bottles for coloring bottles, cut them into 2.0 × 0.3 cm pieces, divide them into three conical flasks with stoppers, and add 4% acetic acid solution (60 ℃ ± 2 ℃, 2 hours), 65% ethanol solution (25 ℃ ± 2 ℃, 2 hours), n-hexane (25 ℃ ± 2 ℃, 2 hours) soaked in 50 ml, with the same batch of 4% acetic acid solution, 65% ethanol solution, and n-hexane as the blank solution, the color of the soaking solution must not be Deeper than the blank solution. White bottles are not subject to this inspection.
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