The technology used in the film material is mostly poly ETFE film, Teflon film, polyethylene film and polypropylene film. Among them, the membrane Teflon is an inert material, its technology products for the food and pharmaceutical industry has been recognized by the U.S. Food and Drug Administration (FDA). Its material properties expressed as a fluorine resin molecular structure with high bonding energy of the carbon-fluorine bond, due to the carbon chain outside the fluorine atoms formed by the shielding effect, so Teflon has excellent drug resistance; membrane ETFE (ethylene tetrafluoroethylene **** polymer) has very good physical and chemical properties, it is a kind of both the PTFE's excellent performance, but also with the Polyethylene easy thermoplastic processing and lower prices of advanced materials, this membrane has a very strong flatness, high level of single-sided active processing. In conclusion, the excellent material properties of fluorinated polymers make it obvious that it has a wide range of applications in isolating pharmaceuticals, 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 the material, which is a technology that enables fluorinated polymers to strongly adhere to the surface of polymer elastomers.
The advantages of laminating technology are: thermal bonding process does not use any organic solvents and adhesives, so there is no chemical residue; direct contact with the drug film is not made surface treatment, very small surface tension can reduce the adsorption of the drug; the film's denseness is good, you can ensure that a good shielding properties and the stability of the drug; drawbacks: easy to film adhesion is not strong, the film is easy to come off, the film is poorly flexible, the laminating adhesive is easy to come off. Film elasticity is poor, the hardness of the laminating plug is large, easy to self-sealing poor, poor pinprick performance and other problems, while the price is also more expensive. A. A molding method for the preparation of fully coated plugs, the process is as follows:
1), the membrane surface activation treatment (chemical or physical methods, generally one-sided treatment)
2), film on the film (membrane activation of the surface of the film material on the unvulcanized mixed film)
3), vacuum molding vulcanization molding
4), molding of the plugs (for the neck and the sealing surface of the film, or for the neck and the sealing surface of the film, or for the neck and the sealing surface of the film, or for the neck and the sealing surface of the film, or for the neck and the sealing surface of the film, or for the neck and the sealing surface of the film. sealing surface lamination, can also be the neck and crown full lamination)
5), punching
B. Secondary molding method for the preparation of film-laminated plugs, the process is as follows:
1), the film surface activation treatment (chemical, physical)
2), film lamination of the film blend
3), vacuum molding vulcanization molding
4), neck molding
5), neck molding
7), the film can be used as a sealing surface, or as the whole of the neck, crown, or the whole of the neck and the crown
8). p>
5), neck punching
6), neck and crown vulcanization adhesive molding
7), neck overlay film molding plugs
8), punching
C. Adhesive molding of the film overlay plugs, the process is to produce the plugs, the surface of the plugs are coated with a layer of adhesive, and at the same time, the film will be pressed into the shape of plugs, and pressed onto the plugs and cured. Curing can be. The key to this technique is the selection of the adhesive and how to apply it evenly, otherwise the film will peel or come off, affecting the use. The film material used in this technology is usually polydimethylsiloxane film, which is a kind of cross-linked dimethylsiloxane oil with appropriate molecular weight and good biological inertness; butyl stopper naturally prevents the adsorption and diffusion of the medicine after coating, which provides a guarantee for the quality of the medicine; at the same time, the surface of the film-coated butyl stopper is very smooth, and it does not need to be silicone in the process of cleaning and using, and it is ready to use after directly sterilizing, which reduces the risk caused by uneven silicone, which is the reason of the lack of uniformity of silicone. The problem of silicone oil particles caused by uneven silicification can be reduced.
The advantages of this technology are: the process route is relatively simple, low cost, has a strong marketing value, market competitiveness. Disadvantages are: the general coating process has more obvious defects is that if the process operation skills are poor, in the vertical and oblique parts of the butyl rubber plugs are prone to sagging and slight film thickness uneven phenomenon.
This technology is usually the process route is: vulcanized film activity treatment → vulcanized film grafting treatment → film coating process → room temperature curing → high temperature curing → cooling curing This process in the butyl plugs on the use of the film material is usually a poly-parylene film (poly-parylene), Parylene polymers are usually three varieties: poly-parylene ( Parylene polymers usually come in three varieties: poly-p-xylene (Parylene N), polychloro-p-xylene (Parylene C) and poly-dichloro-p-xylene (Parylene D). They each have different characteristics and advantages. Their main differences are deposition rate, service temperature and dielectric loss factor. parylene polymer is a chemically inert and biocompatible high purity coating material that has been approved by the FDA and is widely used in a variety of medical devices and packaging materials.
The advantages of vacuum laminating technology are: because Parylene is a unique polymer with post-thermal plasticity, the Parylene coating process is carried out at room temperature, under vacuum, and therefore, can penetrate and cover the object to be treated, the film uniformity and transparency; because of the dry state of the process, there is no catalyst or the presence of organic solvents, there is no hang-ups, loss of liquid. Coating common coating defects, is a true pinhole-free coating film, can be moisture-proof, acid-proof, alkali-proof, anti-bacteria, weather-resistant, heat-resistant (using temperature up to 275 degrees), cold-resistant (minus 200 degrees).
The technical requirements of the vacuum lamination process are: to choose to use specialized vacuum coating equipment, to ensure that the performance of the equipment meets the process requirements. Parylene deposition process
Parylene active monomer Poly-para-xylene
Evaporation chamber Cracking chamber Deposition chamber Cold trap Vacuum pump
Parylene deposition process for the first step in the temperature of about 150 ℃ will be the first step of the solid raw material of paraxylene evaporation, the second step in the temperature of 680 ℃ will be the two side-chain carbon-carbon chain cleavage of the generation of stable active monomer, and finally the active monomer into the room temperature, the last active monomer into the room temperature, and the last active monomer into the room temperature. In the second step, the two side-chain carbon carbon chains are cleaved at 680°C to form stable active monomer, and finally the active monomer enters the deposition chamber at room temperature for polymerization deposition and instantly adsorbs on the substrate to polymerize into poly(p-xylene) film. The remaining gas is trapped by a cold trap to avoid the deposit from entering the vacuum pump.