The pharmaceutical rubber stopper is an integral part of medicine. Its main function is to seal and store the medicine in a relatively small aseptic inert environment, isolated from the external common environment so that the medicine can maintain its efficacy within the validity period. If there is an abnormality of the rubber stopper, the medicine may become invalid or even deteriorate, posing a threat to the lives of the people. The physical properties of the rubber stopper play a decisive role in the sealing of the medicine. The physical properties of rubber stoppers are very important and indispensable to the quality of medicines.
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Insoluble particles of rubber stoppers
The insoluble particles that fall off the surface of the rubber stopper are divided into two types, one is liquid droplets that are insoluble in water, and the other is solid particles. Liquid insoluble particles are mainly silicone oil droplets that fall off the surface of the rubber stopper. This type of insoluble particles can be combined with the powdered drug to make the powder insoluble and affect the efficacy. More seriously, it will reduce the transparency of the drug solution and increase the turbidity, resulting in a phase the capacity is unqualified. The sources of solid insoluble particles are not only the components separated from the rubber stopper formula but also foreign pollution particles; the mutual squeezing and friction of the rubber stoppers during production and transportation will generate particles again. When such insoluble particles come into contact with the liquid medicine, they may enter the liquid medicine and affect the quality of the medicine.
Improvement plan: Design a rubber stopper formula that is not easy to precipitate to reduce the composition of the formula to the surface of the rubber stopper; clean production, reduce particle pollution; optimize transportation methods, reduce friction, and reduce the amount of silicification.
The sealability of rubber stopper and container
The main function of the pharmaceutical rubber stopper is to provide a good seal for the medicine contained in the bottle to prevent the medicine from being contaminated by bacteria and deterioration. Therefore, the importance and necessity of the inspection of the rubber stopper are self-evident. At present, the main materials of domestic rubber stoppers are isoprene rubber or butyl rubber (including chlorobutyl rubber and bromobutyl rubber), both of which have good sealing performance, especially butyl rubber has better airtightness. It is suitable for the production of pharmaceutical rubber stoppers.
Improvement plan: With butyl rubber as the main material, with other additives and processing technology, the production of different specifications of pharmaceutical rubber stoppers can meet the sealing requirements of different specifications of bottles.
Puncture force of rubber stopper
Most of the medicinal rubber stoppers are punctured when the medicine is used. The purpose is to puncture the rubber stopper, pour injection water into the medicine bottle (bag) to dissolve the medicine, or absorb the liquid medicine in the medicine bottle (bag), and then inject it into the human body. This requires a relatively moderate puncture force of the rubber stopper. If the puncture force of the rubber stopper is too large, it will be more difficult for the nurse to operate, which may cause accidents. The factors that affect the puncture force of the rubber stopper include: the high hardness of the rubber stopper, less silicone oil on the surface of the rubber stopper, the improper fit between the rubber stopper and the supporting packaging material, and the puncture device is not sharp enough.
Improvement plan: From the formulation design to make the rubber stopper hardness moderate. From the process design, appropriately adjust the amount of silicone oil on the surface of the rubber stopper. From the rubber stopper structure design to make the rubber stopper and the supporting packaging material fit properly. Select a good quality puncture device, etc. Then we can effectively solve the problem of the large puncture force of the rubber stopper
Sealing after puncture
Sealing after puncture, including inspection items such as self-sealing, sealing at injection points, and leakage of needles. Most medical rubber stoppers need to be punctured when used in terminal hospitals. This not only requires that the rubber stopper has a good seal when it is not punctured but also has a good seal after being punctured to ensure the medicinal container ( For example, the integrity of the bottle), to ensure that the liquid medicine will not leak from the puncture hole during the process of liquid withdrawal and infusion. The main reasons for the poor sealing performance of the rubber stopper after puncture are: poor puncture performance of the rubber stopper, large pieces of debris are produced, and the incision cannot be closed; the elasticity of the rubber stopper is poor, and it cannot rebound quickly to close the incision after being punctured; The thickness of the part is insufficient, and the effect of closing the incision is not good; the rubber stopper has poor compatibility with the bottle and aluminum cap (too loose), etc.
Improvement plan: Optimize the structure, formula and process of the rubber stopper, improve the compatibility of the rubber stopper and the supporting packaging materials, improve the puncture chipping performance and resilience of the rubber stopper, and ensure that the sealing performance of the rubber stopper is qualified after a puncture.
Puncture and chip drop performance
Pharmaceutical rubber stoppers in the end-use often will be punctured. in the process may produce fallen chips into the drug solution, and the number and size of these fallen chips will affect the quality of the drug, so control of plugs punctured fallen chips is very necessary. The main reasons for rubber stopper puncture and chipping are rubber stopper formula technology level, cooperation with other packaging materials, rubber stopper processing methods, puncture quality, operator's technique, use environment, etc.
Improvement plan: increase the rubber content of the rubber stopper, appropriately reduce the product hardness, and appropriately increase the amount of siliconization on the surface of the rubber stopper; the matching degree of the rubber stopper is appropriate, and it cannot be too loose or too tight; the rubber stopper processing method is reasonable; the quality control of the puncture device; Operators are trained in standardized operations; the puncture environment meets the standard requirements, etc.
Puncture device retention
The Puncture device retention includes static retention (needle hanging force) and dynamic retention. Pharmaceutical rubber stoppers used for sealing injection drugs are often used in conjunction with disposable infusion sets for a long time. This requires the rubber stoppers to have a certain static and dynamic retention force, and the infusion set should not fall off during use, so as to avoid accidents. The reasons for the insufficient retention of the puncture may include large silicone oil on the surface of the rubber stopper; low hardness of the rubber stopper; too thin puncture part of the rubber stopper; loose fit with the supporting packaging materials, etc.
Improvement plan: reduce the silicone oil on the surface of the rubber stopper; increase the hardness of the rubber stopper; thicken the puncture part of the rubber stopper; improve the fit between the rubber stopper and the supporting packaging material (appropriate tightness), etc.
A rubber stopper used on a vial serves several critical functions, and its design and composition are carefully chosen to ensure the safe and effective storage and transportation of various substances, particularly in the fields of chemistry, pharmacy, and laboratory work. In this comprehensive explanation, we will delve into the diverse roles of rubber stoppers, their characteristics, and the industries where they are indispensable.
One of the primary functions of a rubber stopper on a vial is to create an airtight and watertight seal, effectively containing the contents within the vial. This hermetic seal is essential for preserving the integrity of the substance inside, be it a chemical compound, medication, or a biological sample. Without a proper seal, the contents could be exposed to the external environment, leading to contamination, degradation, or loss of efficacy.
Rubber stoppers are chosen based on their chemical compatibility with the substance they seal. Different compounds and formulations may react with certain materials, so selecting the appropriate rubber stopper ensures that the substance remains stable and uncontaminated. Common materials used for rubber stoppers include butyl rubber, natural rubber, silicone rubber, and fluorinated rubber, each chosen for its compatibility with specific substances.
In pharmaceuticals and some chemical industries, rubber stoppers are designed to provide tamper-evidence. Once a vial with a rubber stopper has been sealed, it is challenging to access the contents without visibly damaging the stopper. This tamper-evident feature is crucial for ensuring the authenticity and safety of pharmaceutical products and other high-value or sensitive substances.
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Vacuum Rubber Stopper For Blood Collection
While rubber stoppers provide a secure seal, they are also designed for easy removal when necessary. Vials containing medications, reagents, or samples need to be opened for administration, testing, or analysis. Rubber stoppers are engineered to be punctured or removed without difficulty, typically using a syringe, needle, or appropriate tools.
In laboratory and medical settings, rubber stoppers often have self-sealing properties, which allow for repeated injections and extractions without compromising the integrity of the vial's seal. This feature is crucial for processes like liquid chromatography, where samples need to be withdrawn and replaced multiple times.
Rubber stoppers are designed to withstand varying pressure and vacuum conditions. They are commonly used in laboratory glassware, such as flasks and tubes, where the contents may need to be pressurized or subjected to a vacuum. The elasticity and resilience of rubber allow it to expand or contract as needed to maintain a proper seal.
The material and design of rubber stoppers make them highly durable. They are capable of maintaining their sealing properties over time, even when subjected to temperature fluctuations or exposure to chemicals. This durability is essential for long-term storage and transportation of substances.
In pharmaceutical and biological applications, rubber stoppers are sterilized to maintain the sterility of the contents. This is particularly critical in the production of injectable medications and the storage of biological samples. Rubber stoppers can be sterilized using methods like autoclaving, ensuring that no microorganisms are introduced during sealing.
In some cases, rubber stoppers can be reused after proper sterilization and inspection. This reusability is advantageous for reducing waste and cost, particularly in laboratory settings where frequent vial sealing and unsealing are required.
Rubber stoppers come in various sizes and shapes to fit different types of vials, bottles, and containers. The compatibility of the stopper with the specific vial ensures a secure and effective seal. This diversity allows for the sealing of a wide range of substances, from small pharmaceutical vials to large chemical containers.
Rubber stoppers contribute to the safety of laboratory personnel and the public by preventing leaks and spillage of hazardous substances. Proper sealing with rubber stoppers minimizes the risk of exposure to harmful chemicals, toxins, or pathogens.
Rubber stoppers are often color-coded or marked with specific symbols to indicate the type of vial content, its properties, or its intended use. This helps prevent mix-ups and ensures that the right substance is used for a particular application.
In some applications, rubber stoppers can be customized to include features like pre-scored lines for easy breaking, specialized septa for sample analysis, or other unique characteristics tailored to the needs of the specific industry.
In industries like pharmaceuticals and food and beverage, the use of rubber stoppers is highly regulated to ensure the safety and efficacy of products. Rubber stoppers must comply with standards and guidelines set by regulatory bodies, such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA).
In conclusion, rubber vial stopper are essential components in various industries, including pharmaceuticals, chemistry, and laboratory work. They play a crucial role in maintaining the integrity and safety of the substances they seal, whether it's medications, chemicals, or biological samples. Their diverse features, such as chemical compatibility, tamper-evidence, pressure resistance, and ease of removal, make them indispensable tools in these fields. The careful selection and use of rubber stoppers are not only a matter of convenience but also one of safety, quality, and regulatory compliance.
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