Drugs play an important role in safeguarding public health, and their quality has been closely watched by the government. Since the active chemicals in drugs play a role, its stability is directly affected by the packaging materials and packaging forms. Therefore, the packaging of drugs must pay attention.
The "People's Republic of China Drug Administration Law" has a clear standard for drug packaging and management. Packaging materials and containers that are in direct contact with drugs must meet the requirements of pharmaceuticals and meet the standards for ensuring human health and safety. It also approves that pharmaceutical production enterprises must not use unapproved direct contact with packaging materials and containers for drugs. The "Pharmaceutical Production Quality Management Standard" also sets clear requirements for pharmaceutical packaging materials. Therefore, pharmaceutical companies can not ignore the implementation of GMP at the same time. The management of pharmaceutical packaging materials must first be applied to the procurement of packaging materials, followed by specific tools such as inspection, storage, and shipping. In summary, the management of packaging materials is an important component of GMP, and only practical implementation is required. A careful work in order to ensure the quality of good packaging materials can effectively ensure the smooth implementation of GMP.
In order to effectively ensure the quality of drugs, relevant departments must take appropriate measures to improve the quality of drug packaging, establish and improve as soon as possible the standards and management specifications for pharmaceutical packaging, especially pharmaceutical plastics materials, and eliminate unsafe hidden dangers caused by improper packaging.
In recent years, there has been a rapid development in the packaging of pharmaceutical plastic bottles in China. Medicinal plastic bottles have the advantages of light weight, no damage, and hygiene, and meet the special requirements of pharmaceutical packaging. The application of high-quality medicinal plastics can not be accomplished without the improvement of special technical requirements including environment, equipment and personnel.
Plastic packaging container characteristics
Pharmaceutical packaging materials belong to the category of special packaging, which not only has all the attributes of the packaging, but also has special features.
The material of plastic itself is divided into PE, CPP, BOPE, BOPET, BOPA and so on. Due to its superior comprehensive advantages and unmatched advantages of other materials, it will be generally welcomed, although it will cause some harm to the environment. The usage rate will increase rapidly and has partially replaced glass bottles and other materials. Drug manufacturers may select the appropriate pharmaceutical packaging based on the barrier properties of the drug against the packaging materials and the packaging of the drug, taking into account other factors such as transparency, aesthetics, ease of taking the drug, and economy. Plastic packaging containers are packaging materials that are in direct contact with pharmaceuticals. Therefore, in order to ensure that pharmaceutical packaging materials can be used to package pharmaceuticals, it is necessary to monitor the quality of these materials. Based on the specificity of the use of packaging materials for pharmaceuticals, it has the following characteristics:
a. It can protect the drugs from being affected by the environment during storage and use, and maintain the original properties of the drugs.
b. Drugs themselves should have certain stability during storage and use.
c. Drug packaging materials cannot contaminate the drug production environment when wrapping drugs.
d. Drug packaging materials must not contain substances that affect the drug during use.
e. Drug packaging materials and packaged drugs must not have chemical and biological reactions. Requirements for packaging raw materials
Packaging materials, especially packaging materials that are in direct contact with the drug, play a decisive role in ensuring the stability of the drug. Therefore, the applicability of the material will directly affect the safety of the drug. Unsuitable materials can cause migration, adsorption, adsorption, or even chemical reactions of active pharmaceutical ingredients, leading to drug failure and sometimes serious side effects. Therefore, before selecting the container material for a drug, it must be verified whether it is suitable for the intended use. The effect on the stability of the drug must be fully evaluated, and the protective effect of the drug under different environmental conditions during long-term storage should be evaluated.
According to the relevant national laws and regulations, the characteristics of the material are mainly confirmed. According to the different materials, special inspection items such as polyvinyl chloride should be checked for vinyl chloride monomer and polybutylene terephthalate should be checked for residual acetaldehyde. Secondly, the chemical and physical properties of the material were tested, including the amount of material in various solvents, the amount of leachables, the amount of solvent in the composite material, and the tightness of the container. Finally, the microbiological quantity and safety of the material were examined.
In the production process of pharmaceutical plastic bottles, it is unavoidable to generate feeds. In order to reduce costs, individual manufacturers will use excess materials or produce them entirely. After repeated use of recycled materials, the physical properties of the materials will change, which will result in products becoming brittle and decreasing in strength, affecting the shelf life of pharmaceuticals and even reducing their intrinsic quality.
Requirements for the packaging production environment
Pharmaceutical plastic bottle manufacturers must have a clean production environment. The ground, road surface, and transportation of the factory area should not cause pollution to the production of the product. The overall layout of production, administration, life and auxiliary areas should be reasonable and should not interfere with each other. The factory building should be rationally laid out according to the production process and the required level of air cleanliness. Production operations within the same plant and between adjacent plants must not interfere with each other. When designing and constructing a factory building, it should be considered for ease of cleaning when used. The use of drug packaging materials, from the product after the formation of the cleanliness requirements should be the same as the packaging of drug production cleanliness.
The design, selection and installation of the equipment should meet the production requirements, be easy to clean, disinfect or sterilize, facilitate production operations, maintenance, and maintenance, and prevent errors and reduce pollution. The surface of the equipment that is in direct contact with the drug packaging materials that are not in contact with the equipment and used directly should be clean and smooth, easy to clean or disinfect, and resistant to corrosion. Chemical changes do not occur with the packaging materials. Lubricants, coolants, etc. used in the equipment must not cause contamination of the packaging material. Production equipment should have obvious status signs and be regularly repaired, maintained and verified. Equipment installation, maintenance, and maintenance operations must not affect the quality of the product. Unqualified equipment should be moved out of the production area if possible, and there should be obvious signs before being carried out.
The quality of the packaging container
The technical personnel of the pharmaceutical plastic bottle survival company should understand the chemical and physical properties of the bottles they produce, and it should be clear whether the raw materials and auxiliary materials selected for the bottle have an impact on the packaged drugs. If the dosage of the plastic bottle is improper, the migration of trace components will change the medicinal effect of the drug and even endanger the life safety of the drug users. Drugs are a special commodity. Manufacturers of medicinal plastic bottles should be strictly controlled from each production link. They must comply with the relevant requirements of “GMPâ€, and must also grasp the relevant regulations and standards and requirements for the relevant pharmaceutical plastic bottles. At present, most medical plastic bottles in China are used for the packaging of tablets and capsules for pharmaceutical products. Therefore, the production of plastic bottles must protect the drug from moisture deterioration, not easily dissolved by heat, cracking, not easy to encounter photochromism, decomposition, oxidation and contamination.
The packaging materials and containers that are in direct contact with the drug are an integral part of the drug. It is accompanied by the entire process of production, circulation, and use of the drug. Due to differences in drug packaging materials, formulation of containers, choice of raw materials, and different production processes, some components may be dissolved by drugs that are in contact with them, interact with drugs, or be leached and leached by drugs for long periods of time, which directly affects the quality of drugs. Moreover, there are hidden dangers to the quality of medicines and the human body, such as ampoules and infusion bottles. If different formulations and production processes are not used for different drugs, there are often cases where the components are dissolved and the glass is uncoated. Usually, they cannot be found during routine drug tests. For example, the heterosexual proteins dissolved in natural rubber stoppers may be a source of heat for the human body. Dissolution of pyridine compounds is a positive factor for carcinogenicity and teratogenicity, while subtle glass dissociation is a blockage of blood vessel thrombosis or lung granuloma. On the other hand, due to the variety of drugs and the complex active active groups, the requirements for packaging materials and containers in direct contact with them are much higher than those of other products.
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