Membrane Technology and Application of Glass Bottle Butyl Rubber Plug
This article (China Packaging Bottle Net) makes a simple statement on the status quo and development trend of the butyl rubber plug's membrane technology for your colleagues to read, and hopes to inspire you.
one. Butyl rubber plug membrane technology
Due to its many advantages, the butyl rubber plug coating can effectively reduce the absorption, adsorption, leaching and infiltration between the rubber plug and the drug, and improve the long-term stability of the drug; for example, by forming a film on the surface of the rubber plug. The mechanical lubricity of the rubber plug greatly reduces the increase in the amount of insoluble particles in the liquid due to the silicone oil.
In foreign countries, since the production technology of butyl rubber plugs has taken a long time to develop, such as Japan's production of butyl rubber stoppers in 1957, various economically developed countries in Europe and America also began to mass produce pharmaceutical butyl rubber stoppers in early 1970; Domestically, until 1992, materials began mass production of pharmaceutical butyl rubber stoppers. At the same time, the butyl rubber film coating technology has been developed earlier in the world and the technology is relatively mature. For example, the West Company of The West Company, the Japanese company Nikko Corporation, the Helvoet Company of Belgium, etc. all have different styles. Film-coated butyl rubber plugs, and all have the capacity of mass production. In China, due to the relatively late development of membrane technology for butyl rubber plugs, there are not many manufacturers capable of mass-producing coated butyl rubber plugs and the product quality is relatively stable, but the technicians of domestic butyl rubber plug manufacturers have undergone a large number of tests. , Continuously explore and exchange, there are some manufacturers can mass produce stable quality coated butyl rubber stopper, through the long-term stability test of pharmaceutical companies, and the long-term stability of the relevant drug solution reflects a good result, but also according to the State Bureau No. 13 Order The relevant requirements are for the registration of new drug packaging materials. The following describes the film material requirements, types of film materials, various coating techniques and characteristics of film-covered butyl rubber plugs.
(I) Requirements of film materials for film-covered butyl rubber plugs (Chinese bottle nets)
1) Very low gas permeability.
2), strong water vapor permeability.
3) High chemical resistance.
4) High heat aging resistance.
5) High internal cleanliness.
6), good resistance to ozone and weather resistance.
7) Stable radiation disinfection.
8) It should be non-toxic, odorless and non-polluting.
9) It should have good flexibility.
(B) commonly used film materials
According to the characteristics of the coating material, the most commonly used coating materials are the following:
Polydimethylsiloxane film Poly-p-xylene film Poly-Teflon, ETFE film Polyester film.
(III) Introduction to various coating technologies for film-covered butyl rubber plugs
1, film technology
Most of the membrane materials used in this technology are poly-ETFE membranes, Teflon membranes, polyethylene membranes, and polypropylene membranes. Among them, the film Teflon is an inert material whose technical products have been approved by the U.S. Food and Drug Administration (FDA) for use in the food and pharmaceutical industries. Its material properties are expressed as the carbon-fluorine bond with high bond energy in the molecular structure of the fluorine resin. Because of the shielding effect formed by fluorine atoms outside the carbon chain, Teflon has excellent chemical resistance; the film ETFE (ethylene)? Tetrafluoroethylene copolymer) has excellent physical and chemical properties. It is an advanced material that not only has the excellent performance of PTFE, but also has the advantages of easy thermoplastic processing and low price of polyethylene. This film has a very high flatness. Single-side active treatment features high levels. In conclusion, the excellent material properties of the fluorinated polymer make it a very broad application in isolating drugs, but its extremely low surface energy makes it the most difficult polymer to bond. Therefore, it is particularly important to study the surface treatment technology of materials, which is a technology that can make fluorinated polymers strongly adhere to the surface of polymer elastomers.
The advantage of the film technology is that the heat sealing process does not use any organic solvents and adhesives, so there are no chemical residues; the film that is in direct contact with the drug does not undergo surface treatment, and the minimal surface tension can reduce the adsorption of the drug; Good compactness can ensure good shielding performance and stability with the drug; disadvantages are: easy to film adhesion is not strong, the film is easy to fall off, the membrane material is poor elasticity, plastic rubber coating hardness is relatively large, easy to appear from Poor sealing, poor acupuncture and other issues, while the price is more expensive.
Film technology can be divided into three types:
A. A full-coverage rubber stopper is prepared by a single molding process as follows:
1) Membrane surface activation treatment (chemical or physical method, generally one-side treatment)
2) Film on the film (the surface on which the film material is activated is affixed to the unvulcanized compound film)
3)ã€Vacuum molding vulcanization molding 4)ã€Forming rubber plug (can be neck and sealing surface coating, also can be full coating of neck and crown)
5) Punching
B. The secondary molding method to prepare the covered rubber plug, the process is as follows:
1) Membrane surface activation treatment (chemical, physical)
2) Film coating on the mixed film 3) Vacuum compression molding vulcanization molding 4) Neck molding 5) Neck punching 6) Neck and crown vulcanization bonding molding 7) Neck film forming adhesive Plug 8), punching
C. Adhesive-molded film-covered rubber plugs. This process involves first producing rubber plugs, applying a layer of adhesive to the surface of the rubber plugs, compressing the film into rubber plugs, and applying pressure to the rubber plugs. Tightening can be. The key to this technology lies in the choice of adhesive and how to apply it uniformly. Otherwise, peeling or film peeling will occur, which will affect the use.
2, dipping, spraying and brushing technology
The membrane material used in this technology is usually a polydimethylsiloxane membrane, which is a cross-linked dimethyl silicone oil with suitable molecular weight and good biological inertia; the butyl stopper naturally hinders the drug after it is coated. Adsorption and diffusion provide a guarantee for the quality of pharmaceuticals; at the same time, the surface of the coating butyl rubber plug is very smooth, no silicidation is needed during cleaning and use, and sterilization can be used directly to reduce the uneven siliconization. Caused silicone oil particles problem.
The advantages of this technology are: relatively simple process route, low cost, strong market promotion value, and strong market competitiveness. The disadvantages are: The obvious defects in the general coating process are that if the process operation skills are poor, sag and slight uneven film thickness are likely to occur in the vertical and inclined parts of the butyl rubber plug.
The usual process routes of this technology are: Active treatment of vulcanized film → Grafting treatment of vulcanized film → Coating process → Curing at room temperature → Curing at high temperature → Curing after cooling
3, vacuum coating process
The coating material used for this process on butyl rubber plugs is usually poly-parylene. Parylene polymers are usually of three types: parylene N, poly-p-xylene. (Parylene C) and Polydichloroparaxylene (Parylene D). Each of them has different characteristics and advantages. Their main differences are deposition rate, operating temperature, and dielectric loss factor. Parylene polymer is a kind of high-purity coating material with good chemical inertness and good biocompatibility. It has been approved by FDA and has been widely used in various medical equipments and packaging materials.
The advantage of vacuum coating technology is that because Parylene is a unique, thermally post-plastic polymer, the Parylene coating process is carried out at room temperature and under vacuum, and therefore can penetrate and cover the objects to be processed. The film is uniform and transparent; because it is a dry process, there is no catalyst or organic solvent, there is no coating defect common to liquid coating such as sagging and loss, and it is a true pinhole-free coating film, which can prevent moisture and acid. Anti-alkali, anti-bacterial, anti-weathering, high temperature (use temperature up to 275 degrees), anti-cold (minus 200 degrees).
The requirements of the vacuum coating technology are: To use a special vacuum coating equipment to ensure that the equipment performance meets the process requirements.
The technical route of the vacuum coating process is:
Parylene deposition paraxylene reactive monomer parylene evaporation chamber cracking chamber deposition chamber cold trap vacuum pump
The Parylene deposition process is the first step to evaporate the solid feedstock p-xylene at a temperature of about 150° C. The second step is to cleave the two side chain carbon-carbon chains at 680° C. to form a stable reactive monomer, and the final activity sheet. The body enters the deposition chamber in the room temperature to perform polymer deposition and instantaneously adsorbs on the substrate to polymerize into a parylene film. The remaining gas is trapped in the cold trap to avoid deposits entering the vacuum pump.
two. Development trend of butyl rubber plug film technology
According to the above brief introduction of (China Packaging Bottle Net), combined with the current status of domestic and foreign butyl rubber plug membrane technology, to obtain a butyl rubber plug with good film forming performance, with the following trends:
1. The elasticity and flexibility of the film are better and uniform.
2. Membrane materials should have good biological stability and biocompatibility, and must undergo rigorous biological tests. Tests include acute systemic toxicity test subcutaneous toxicity test.
3. The membrane material and the butyl rubber plug are not easy to fall off after they are combined and cause secondary pollution.
4. The membrane material must have good isolation performance, which can effectively prevent the absorption of metal ions in the butyl rubber plug by the chemical solution.
5. It has good lubricity. Due to the movement of the butyl rubber plug during the filling process of the liquid medicine, good lubricity can ensure that the butyl rubber stopper moves efficiently on the conveying track, ensuring the production efficiency of the pharmaceutical factory.
6. The membrane material must have good thermal stability and high temperature sterilization resistance, because the butyl rubber plugs have to go through various sterilization and sterilization processes in different liquids, such as high-pressure damp heat sterilization, dry heat sterilization, Radiation sterilizing and so on.
7. The process is simple, safe, and efficient. It is also the pursuit of the technical personnel in the development of butyl rubber plug membrane technology.
Three. Summary
In short, the development of membrane technology for butyl rubber plugs is still relatively new in the country. It is necessary to mass-produce plastic butyl rubber plugs that can be accepted by the majority of domestic pharmaceutical companies, and it is also necessary for technicians of domestic butyl rubber plug manufacturers to continue Explore the optimization, find the right membrane material, find a simple and fast process, and then mass produce the coated butyl rubber plug to meet the needs of pharmaceutical companies.
Reproduced, please indicate the source: Chinese bottle net
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