With excellent chemical stability, air tightness, low extractability and good biological properties, butyl rubber stoppers provide a reliable guarantee for drug quality.
There are two main production processes for butyl rubber stoppers at present.
▷ Injection process
Mating → Refining out strip → Vulcanization → Punching → Pre-cleaning → Cleaning → Inner wrapping → Outer wrapping
▷Molding process
Mating → refining (dense refining, open refining) → hot refining or extrusion pressing → cutting and weighing → vulcanization → punching → pre-cleaning → cleaning → inner packaging → outer packaging
For moulding, due to the poor thermal conductivity of the rubber, the internal temperature of the rubber layer rises slowly, and the temperature difference between the inner and outer layers is large, so when the outer layer enters the best vulcanization stage, the inner layer starts to vulcanize and is in the under-sulfur stage. When the inner layer rubber reaches the best vulcanization stage, the outer layer rubber is already over sulfur. Therefore, the greater the temperature difference between the inner and outer layer rubber, the greater the impact on product quality, the use of low-temperature vulcanization, can make the inner and outer layer rubber temperature curve by disturbing, but to greatly extend the vulcanization time, thus low efficiency. The injection vulcanization process itself provides the condition of uniform temperature of inner and outer rubber, thus giving the possibility of high temperature vulcanization.
Among them, the quality of butyl rubber pharmaceutical stopper depends largely on the quality of vulcanization molding, and the vulcanizer is the key and important equipment. Out of the characteristics of butyl rubber with good gas tightness and poor thermal fluidity, this requires the vulcanizing machine to have the ability to make the mold close and open repeatedly under vacuum in a short period of time so that the gas is continuously extracted. Meanwhile, in order to make the butyl rubber in molten state flow in the mold cavity and make the crown of the stopper of uniform thickness, the vulcanizing machine must have high pressure to force the rubber to flow during molding, and the hot plate of the vulcanizing machine It also needs to have a high uniform and consistent temperature, and a stable vulcanization time at a constant temperature.
Under a suitable formulation of vulcanization system, usually produced at about 195℃, the product has less bubbles, high qualification rate, high production efficiency and more stable size. Therefore, injection vulcanizing machine has been a trend in the development of butyl rubber plug processing at present.
The professional cleaning machine has the functions of strong impact, self-cleaning, centrifugal shaking dry, and the cleaning time is short, and the cleaning produces less rubber filaments and rubber chips, and the silicone oil is more accurate and uniform, thus ensuring the better cleanliness of the finished plugs. Of course, from the generation of particles and dropable foreign matter, it is important to strengthen the production environment control, improve the quality awareness of employees, and restrain from the rules and regulations.
▷We are developing the use of butyl plugs to meet the needs of a wide range of therapeutic infusion drugs, with a wide range of adaptability and excellent long-term stability.
▷ Ultra-clean stoppers to ensure low extraction when compatible with drugs.
▷ Selection of rubber and main raw materials.
Due to the various raw materials in the formula, there is a concentration gradient relationship, and in the process of use, after the drug is adsorbed and absorbed by the stopper, it starts to penetrate and extract, thus contaminating or destroying the drug and reducing the efficacy, especially the acidic or alkaline drugs, which may destroy the rubber stopper. Therefore, in the production of good control of precipitates, the choice of high purity, stable performance of raw materials is very important, but also pay attention to the "solubility parameters" of the raw materials, according to the "similar solubility" principle, can reduce the migration of various ingredients in the plug, and improve the compatibility with the drug The principle of "similar solubility" can reduce the migration of various ingredients in the stopper and improve compatibility with drugs.
Film-coated stoppers have become a hot topic of development in the industry. Film coated stoppers are good for improving the compatibility of stoppers with drugs, especially for I.V. stoppers. Nowadays, there are three main coating or laminating technologies: first, direct coating on the surface of the stopper, the film material is incompletely fluorinated polyethylene material, dissolved with organic solvent and then coated; second, activation of the surface of the stopper, and then chemical grafting reaction with the graft material, in which the graft monomer and the precursor stopper are connected by a common bond to achieve surface inerting treatment, the selection of a suitable coating path and excellent film material is Third, a special polymer material is applied to the surface of butyl plugs by vacuum electroplating.
No-clean gel plugs are already being tried. Usually the ordinary butyl rubber plugs, which need to be cleaned and sterilized before use in pharmaceutical factories, are to be sterilized in the following process: the plugs are cleaned with pure water conforming to pharmacopeial standards, then cleaned with injection water conforming to pharmacopeial standards, silicified and dried, and then cooled and packaged in a class 100 clean environment, where the special bags are put directly into the steam cabinet sterilization cabinet and dried. The thermogenic, bacterial load and particle indexer of the no-clean gel plugs are to be controlled.
▷ Strict requirements for product quality, focus on batch stability, and tighter control of visible and invisible particles.
▷ The stopper meets various physical and chemical performance requirements with less chip fall.
Needle drop has now become one of the focus of many pharmaceutical companies. Needle structure is one of the main factors affecting needle drop, in addition, good plasticizers should be selected in the composition of the formula, so that the fixed extension stress of the rubber is lower, which can reduce needle drop.
In conclusion, the antibiotics and infusion preparations such as penicillin sodium salt for injection, penicillin zinc salt, aminopenicillin, sulfur streptomycin, oral liquid biological products, all use butyl glue plugs, if you have order requirements for butyl glue plugs, please contact us.
