Attention should be paid to drug packaging contain

2022-06-21
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For any product, the purpose of packaging is to protect the whole process from loading and unloading, transportation, storage to users' use. The packaging form shall be determined according to the relevant characteristics of the product. The materials used for packaging shall be compatible with the packaged product and have no impact on the quality of the packaged product. As a kind of special products, drugs play an important role in maintaining public health, and their quality has been paid close attention by governments all over the world. As active chemicals play a role in drugs, their stability is directly affected by packaging materials and packaging forms, so the packaging of drugs should be paid special attention

however, pharmaceutical enterprises have always focused on the production and processing process, and have not paid enough attention to the packaging link. At the same time, it is common to see cases of drug safety and even major brewing accidents due to improper packaging materials. In order to effectively ensure the quality of drugs and ensure the safety of public medication, it is suggested that relevant departments must take corresponding measures to improve the quality of drug packaging, establish and improve the standards and management specifications for drug packaging, especially pharmaceutical plastic materials, as soon as possible, and eliminate the hidden dangers of unsafe drug use caused by improper packaging. In recent years, medical plastic bottle packaging in China has developed rapidly. The safety of plastic and other parts used in medical kitchen appliances has attracted more and more attention. Plastic bottles have the advantages of light weight, no damage, sanitation and so on, and meet the special requirements of drug packaging. The application of high-quality medical plastics is inseparable from the improvement of special technical requirements including environment, equipment and personnel

overview of plastic packaging containers

even if biodegradable plastic bags are used, they refer to the containers that contain and protect products. They play an important role in maintaining product quality, reducing losses, facilitating transportation, storage and sales, beautifying goods and improving service quality. Because drug packaging materials are used to package special commodities - drugs, drug packaging materials belong to the category of special packaging. They have all the attributes of packaging and have particularity

the materials of plastics include PE, CPP, BOPE, BOPET, BOPA, etc. Due to its strong comprehensive advantages and incomparable advantages of other materials, although it will cause certain harm to the environment, it is still popular. Its consumption has increased rapidly and has partially replaced other materials such as glass infusion bottles. Drug manufacturers can select appropriate pharmaceutical packaging according to the barrier performance requirements of drugs on packaging materials and the packaging form of drugs, and comprehensively consider other factors such as transparency, aesthetics, convenience of taking drugs, economy, etc. Plastic packaging containers are packaging materials that directly contact drugs. Therefore, in order to ensure that drug packaging materials can be used to wrap drugs, it is necessary to monitor the quality of these materials. According to the specificity of the use of drug packaging materials, they have the following characteristics: bra. they can protect drugs from the impact of the environment during storage and use, and maintain the original properties of drugs

b. the nature of the drug should be stable during storage and use

c. drug packaging materials shall not pollute the drug production environment when wrapping drugs

d. drug packaging materials shall not contain substances that can not be eliminated during use and have an impact on drugs

e. there shall be no chemical or biological reaction between the drug packaging materials and the packaged drugs

requirements for raw materials

packaging materials, especially those in direct contact with drugs, play a decisive role in ensuring the stability of drugs, so the applicability of materials will directly affect the safety of drugs. Unsuitable materials can cause the migration, adsorption, adsorption and even chemical reaction of active drug components, resulting in drug failure, and sometimes serious toxic and side effects. Therefore, before selecting container materials for drugs, it is necessary to verify whether they are suitable for the intended use. It is necessary to fully evaluate the impact on the stability of drugs and evaluate whether they are suitable for different environmental conditions during long-term storage? Temperature, humidity, light, etc? Protective effect of snow containers on drugs

according to relevant national regulations and standards, the characteristics of materials shall be mainly confirmed, and special inspection items shall be set according to different materials, such as vinyl chloride monomer and polyethylene terephthalate for PVC? Acupoint pet? Snow materials should be checked for acetaldehyde residues. Secondly, the chemical and physical properties of the materials are tested, mainly including the amount of the material extracted in various solvents, harmful substances, residual solvents in the composite materials, container tightness, etc. Finally, the microbial quantity and safety of the material were tested. Failure to meet the above indicators will lead to qualitative change of drugs and endanger health

in the production process of pharmaceutical plastic bottles, it is inevitable to produce recycled materials? Second material? Snow, in order to reduce costs, some manufacturers will use excess or all recycled materials for production. After repeated use, the physical properties of the returned material will change, which will lead to product embrittlement, lower strength, affect the storage life of the drug, and even reduce its internal quality

requirements for production environment

pharmaceutical plastic bottle manufacturers must have a clean production environment; The ground, pavement and transportation of the plant shall not cause pollution to the production of products; The overall layout of production, administration, living and auxiliary areas shall be reasonable and shall not interfere with each other. The plant shall be reasonably arranged according to the production process flow and the required air cleanliness level. Production operations in the same plant and between adjacent plants shall not interfere with each other. In the design and construction of the plant, it shall be considered that it is easy to clean when it is used. Clean Room? Acupoint area? The inner surface of the snow shall be flat and smooth without cracks, tight interfaces, no particles falling off, and can withstand cleaning and disinfection. The junction between the wall and the ground should be curved or other measures should be taken to reduce dust accumulation and facilitate cleaning. Enter the clean room? Acupoint area? The snow air must be purified. For drug packaging materials that are used without washing in production, the cleanliness requirements of each process after the product is formed shall be the same as the production cleanliness of the packaged drugs

the design, type selection and installation of the equipment shall meet the production requirements, be easy to clean, disinfect or sterilize, be convenient for production operation, repair and maintenance, and prevent errors and reduce pollution. The surface of the equipment in direct contact with the drug packaging materials that are in direct contact with the drug packaging materials that are used without washing shall be smooth, easy to clean or disinfect, corrosion-resistant, and free from chemical changes with the drug packaging materials. The lubricant and coolant used in the equipment shall not pollute the drug packaging materials. The production equipment shall have obvious status signs, and shall be regularly repaired, maintained and verified. The operation of equipment installation, repair and maintenance shall not affect the product quality. Unqualified equipment shall be moved out of the production area if possible, and there shall be obvious signs before moving out

requirements for product quality

the technical personnel of the survival enterprise of pharmaceutical plastic bottles should understand and be familiar with the chemical and physical properties of the medicine bottles they produce, and should be clear about whether the raw materials and auxiliary materials used for bottle making have an impact on the packaged drugs. If the dosage used in making plastic bottles is improper, the migration of trace components will change the medicinal effect of drugs, and even endanger the life safety of drug users. Drugs are a kind of special commodities. Manufacturers of pharmaceutical plastic bottles should strictly control each production link, comply with the relevant requirements of "GMP", and master the relevant laws and regulations as well as the standards and requirements of pharmaceutical plastic bottles. At present, most of the pharmaceutical plastic bottles in China are used for the packaging of tablets and capsules. Therefore, the produced plastic bottles must protect the drugs from moisture deterioration, which will help to improve the effectiveness of packaging and sorting in plastic recycling, and are not easy to be dissolved and burst by heat, discoloration, decomposition, oxidation and bacteria infection

packaging materials and containers in direct contact with drugs are an integral part of drugs, which accompany the whole process of drug production, circulation and use. Especially for pharmaceutical preparations, some dosage forms are dependent on packaging? Acupoints such as capsule, aerosol, water injection, etc? snow. Due to different drug packaging materials, container composition, selected raw and auxiliary materials and production processes, some components may be dissolved by the drugs they come into contact with, or interact with the drugs, or be corroded by the drugs for a long time, which will directly affect the drug quality. Moreover, some have hidden dangers to the drug quality and human body? Acupoint means that the problems can not be found in time through the routine inspection of drug quality and human body? snow. Such as ampoules, infusion bottles? Pocket? Snow, if different formulas and production processes are not adopted for different drugs, components will often be dissolved and glass flakes will fall off, which can not be found during routine drug inspection. For example, the foreign protein dissolved in natural rubber plug may be a heat source for human body, the dissolved pyridine compounds are a positive factor for carcinogenesis, teratogenesis and mutagenesis, and subtle glass flakes are hidden dangers of blocking blood vessels, forming thrombus or pulmonary granuloma, etc. On the other hand, due to the variety of drugs and the complexity of effective active groups, the requirements for packaging materials and containers in direct contact with them are much higher than those for other products

conclusion

the drug administration law of the people's Republic of China has been revised, which regulates the management of drug packaging. Direct contact with drug packaging materials and containers must meet the pharmaceutical requirements, meet the standards to protect human health and safety, and be approved by the drug supervision and administration department when approving drugs. Drug producing enterprises shall not use unapproved packaging materials and containers that directly contact drugs

in order to strengthen the management of drug packaging materials and containers, the State Drug Administration adopted and promulgated the measures for the management of packaging materials and containers in direct contact with drugs No. 13 on june18,2004. The categories of drug packaging materials subject to registration management were clearly defined, and the production flow links of drug packaging materials were spot checked.

the specifications for the quality management of drug production also put forward clear requirements for drug packaging materials, Therefore, pharmaceutical enterprises should not ignore the management of pharmaceutical packaging materials while implementing GMP. First of all, we should control the purchase of packaging materials. Second, we should carefully do a good job in the specific tools such as inspection, warehousing and delivery. In short, the management of packaging materials is an important part of GMP. Only by doing a good job in every step can we control the quality of packaging materials and effectively ensure the smooth implementation of GMP

source: China electromechanical

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