Effective control of infusion stoppers
With the development of medical science and technology, various infusion preparations have higher and higher requirements for visible particles and invisible particles (collectively referred to as insoluble particles) of cork stoppers, and are particularly concerned about the particulate factors and how to control the cork stoppers in applications.
I. In recent years, in order to meet the requirements for the butylation of bottles, various infusion preparation plants have tried and improved the cork packaging. However, in the process of switching, they all encountered substantial problems. The most serious problem is the control of particulates. . We analyze the following:
Glass bottle stoppers and plastic stoppers are stoppers that are in direct contact with pharmaceutical preparations, while soft-bag packaging used in mouth gaskets (bottle stoppers) is just a kind of isolation and sealing effect. The former is particularly strict with particle control requirements, but the latter is made of a translucent plastic material used in the mouth tube. There are still some liquids in the mouth tube that cannot detect hidden particulate matter, affecting the clarity. Some European countries took the lead in adopting poly carbonate resin. Transparent mouthpieces, and the stoppers are in direct contact with the drug formulation, plus an aluminum plastic cover.
Second, we believe that China's current infusion packaging is divided into three types (1) glass bottles (2) polypropylene plastic bottles (3) non-PVC soft bags, these three kinds of packaging are inseparable from the bottle stopper. The original glass bottle stopper is used in the application. In order to avoid the particulate contamination agent, a natural rubber plug with a padding polyester film is used for the purpose of ensuring that no insoluble particles are produced in the preparation, and the clarity is not affected, so that the medicine is safe and effective.
Third, according to the above three types of infusion bottle cork, the source of particles appears as follows:
1. During the vulcanization molding and slicing process, it is contaminated by the production environment.
2. Artificial contamination of production employees (dander, hair, fiber).
3. The indirect friction between the cork and the bottle stopper and the indirect friction between the cork and the cylinder of the cleaning equipment during the post-treatment of the cork will gradually produce particles in the process, and more serious The particles caused by the direct friction produced when the corks are dried are quite amazing. Our experience in the past 14 years is that the longer the washing, the dirtier the washing. “Because the corks themselves have electrostatic adsorption.†(Recommended to use disposable plastic stopper)
4. The butyl stopper itself will generate static electricity and the adsorption force is very strong. It is impossible to remove the stopper surface particles by ordinary cleaning methods.
5. Pressure of the heat produced by the stopper when the formulation container is sterilized by pressure after squeezing causes contaminating infusion of invisible particulates, ie, exudates and insoluble particulates, produced inside the bottle and inside the stopper.
6. The silicone oil itself has a particle size of 13-18 microns.
Fourth, the method of control
1. The rationality of the formula.
2. Resolve the cork particles in the key process workshops and sections must be air purifying, require the implementation of GMP total quality management, grasp the particle source control.
3. The stopper mold should be smooth in contact with the drug cavity, making it less likely to attract various particles.
4. All tooling equipment should be made of stainless steel as much as possible. The compressed air used for production must be degreasing, water removal, and dust removal.
5. Because the stopper is an elastomer, it is easy to produce particles after friction. Therefore, static cleaning and vacuum defoaming should be used in the post-treatment of the stopper to reduce the frictional collision. (You can also use static cleaning method, Lanling has a special equipment process patent)
6. Invisible particles (extracts) take special processes (high temperature, high pressure, pressure holding, extraction).
7. When the stopper is dry, a special process should be adopted (semi-static drying, both to ensure not sticking, but also to make the rubber plug does not clump).
8. The infusion plant should open the layer package strictly according to different levels of the process environment before using the rubber plug. First check its clarity, number of particles and particle diameter. If it is unqualified, it shall be immediately returned to the bottle stopper factory for disposal. Doing repeated cleaning causes contamination.
9. Use large-capacity, small-diameter containers as much as possible to reduce the degree of contamination of the stoppers and to reduce the amount of acupuncture particles and beads (but not to break through the stoppers at high pressure).
10. High value-added formulations use butyl overwrap rubber plugs.
11. The level of silicidation is determined, and the best use of a special rubber plug post-processing equipment results in the absence of silicone oil in the contact liquid.
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