For any kind of product, the purpose of packaging is to protect the product from handling, transportation, storage to the end of the whole process of user use. The form of packaging should be based on the relevant characteristics of the product, and the materials used for packaging should be compatible with the packaged product and have no effect on the quality of the packaged product. As a class of unique products, pharmaceuticals play an essential role in maintaining public health, and governments have closely monitored their quality. As the part of drugs is the active chemical substances, its stability by the packaging materials and packaging form of direct impact, so the packaging of drugs need to pay particular attention.
However, the focus of pharmaceutical companies on drug quality has been on the production and processing process. Packaging has not given sufficient attention to the link. At the same time, the inappropriateness of packaging materials and affect the safety of drugs or even brew significant accidents are not uncommon examples. To effectively ensure the quality of drugs, to protect the safety of the public medication, it is recommended that the relevant departments must take appropriate measures to improve the quality of drug packaging as soon as possible to establish and enhance the standards and management of pharmaceutical packaging, especially pharmaceutical plastic materials, to eliminate the hidden danger of drug insecurity caused by improper packaging.
Pharmaceutical plastic bottles have the advantages of a lightweight, no breakage, hygiene, etc., which meet the unique requirements of pharmaceutical packaging. The application of high-quality pharmaceutical plastics cannot be achieved without improving special technical needs, including environment, equipment, and personnel.
Packaging refers to the container that holds and protects the product. It has a vital role in maintaining product quality, reducing losses, facilitating transportation, storage, and sales, beautifying goods, and improving the service quality. Pharmaceutical packaging materials are used for special packaging goods-drugs, so pharmaceutical packaging materials belong to the category of special packaging; it has all the properties of packaging and has a unique nature.
The plastic material itself is divided into PE, CPP, BOPE, BOPET, BOPA, etc. Because of its solid, comprehensive advantages and the incomparable superiority of other materials, although it can cause some harm to the environment, still generally welcomed, its use is proliferating, has partially replaced other materials such as glass infusion bottles. Drug manufacturers can be by the requirements of the barrier properties of packaging materials and drug packaging forms and other factors such as transparency, aesthetics, ease of access, economy, etc., to choose the appropriate pharmaceutical packaging. Plastic packaging containers are packaging materials that come into direct contact with drugs. Therefore, to ensure that pharmaceutical packaging materials can be used to wrap drugs, it is necessary to quality control these materials, according to the specificity of the use of pharmaceutical packaging materials, which have the following characteristics.
a.protect the drug in storage, use process from the impact of the environment and maintain the drugs' original properties.
b.The drug itself should have specific stability in the storage and use process
c.Pharmaceutical packaging materials in the wrapping of drugs can not contaminate the drug production environment
d.Drug packaging materials should not have in the process of use can not be eliminated on the drug substances that have an impact
e.Drug packaging materials and the drugs packaged can not have a chemical, biological sense of the reaction.
Packaging materials, especially those in direct contact with the drug, play a decisive role in ensuring the stability of the drug, so the suitability of the material will directly affect the safety of the drug. Unsuitable materials can cause the migration of active pharmaceutical ingredients, absorption, adsorption. Even chemical reactions occur, leading to drug failure and sometimes severe toxic side effects. Therefore, before selecting a container material for a drug, it must be tested to confirm its suitability for the intended use. The impact on the stability of the drug must be thoroughly evaluated. The effect of the container on the strength of the medicine must be thoroughly evaluated to assess its effectiveness in protecting the drug under different environmental conditions(such as temperature, humidity, light,etc.)during long-term storage.
According to the relevant national regulations and standards, we mainly confirm the characteristics of the materials. Special inspection items should be set according to different materials, such as vinyl chloride monomer(VCM)for PVC and glycol polyethylene terephthalate(PET)for acetaldehyde residue. Secondly, the chemical and physical properties of the material should be inspected, including the amount of leached material in various solvents, hazardous substances, solvent residues in composite materials, and container sealing. Finally, the number of microorganisms and the safety of the material are tested. If the above indicators do not meet the standards, it will lead to the quality change of drugs and health hazards.
In the production process of pharmaceutical plastic bottles, it is inevitable to produce back materials(secondary materials) to reduce costs. In order to reduce the cost, individual production manufacturers will use excessive or all of the return material production Return material after repeated use, its physical properties change. It will cause the product to become brittle, reduce the strength, affect the storage life of drugs, and even reduce its intrinsic quality.
Pharmaceutical plastic bottle production enterprises must have a clean production environment; plant ground, road, and transport should not cause pollution of products; production, administration, living and auxiliary areas of the overall layout should be reasonable, not to interfere with each other. Plant should be by the production process and the required air cleanliness level for a good design.
The same plant and the production operations between adjacent plants shall not interfere with each other. In the design and construction of the plant.Should consider the use of easy to clean on the work. The inner surface of the cleanroom(area)should be smooth, no cracks, familiar interfaces, no particles off, and can withstand cleaning and disinfection; the junction of walls and floors should be curved or take other measures to reduce the accumulation of dust and easy to clean. The air entering the cleanroom(area)must be purified. The production of pharmaceutical packaging materials without washing, the cleanliness requirements of each process since the product is formed should be the same as the cleanliness of the production of packaged drugs Equipment design, selection, installation should meet the production requirements, easy to clean, disinfection or sterilization, easy to produce operation and repair, maintenance, and can prevent errors and reduce pollution. Direct contact with the direct contact, direct contact with the drug package without washing the surface of the equipment should be clean and smooth, easy to clean or disinfect, corrosion-resistant. It does not occur with the drug package chemical changes.
Equipment used in the lubricant, coolant, etc., shall not cause contamination of pharmaceutical packaging materials. Production equipment should have a clear state mark and regular maintenance, maintenance, and inspection. Equipment installation, repair, maintenance operations shall not affect the quality of products. Unqualified equipment should be moved out of the production area; if possible, it should be clearly marked before moving out.
The technical personnel of pharmaceutical plastic bottle survival enterprises should be familiar with the chemical and physical properties of the pharmaceutical bottles they produce and should be clear about whether the raw materials and excipients chosen for the bottles impact the drugs they are packaged with. If the production of plastic bottles with improper dosage, the migration of trace components will change the medicinal effect of drugs and even endanger the lives of people taking drugs. Drugs are a particular commodity. Manufacturers of pharmaceutical plastic bottles should be strictly controlled from each production step to meet the requirements of "GMP" and to master the relevant laws and regulations and the standards and requirements of pharmaceutical plastic bottles. Most of the plastic bottles for pharmaceuticals in China are used for packaging tablets and capsules. Therefore, the production of plastic bottles must protect the drug is not accessible to moisture deterioration, not easily dissolved by heat.
Direct contact with pharmaceutical packaging materials and containers is an integral part of the drug. It accompanies the whole process of drug production, circulation, and use. Especially pharmaceutical preparations, some dosage forms are inherently dependent on packaging (such as capsules, aerosols, water injections, etc.). As the drug packaging materials, container composition formula, the choice of raw and auxiliary materials, and different production processes. Some components may be contacted by the drug leaching, interact with the drug, or by the drug long-term immersion corrosion off the piece and directly affect the quality of medicines.
Moreover, some of them have hidden effects on the quality of drugs and the human body (i.e., the problems cannot be found in time through the routine inspection of drug quality and the human body). For example, suppose ampoules and infusion bottles (bags) are not used for different drugs with different formulations and production processes. In that case, there are often dissolved components and glass flakes that cannot be detected during routine drug testing. For example, the dissolved anisotropic proteins in natural rubber plugs may be thermogenic to humans. The dissolved pyridine compounds are a definite factor in carcinogenesis, teratogenesis, and mutagenesis. And the fine glass flakes are blocking blood vessels to form thrombosis or lung granuloma hidden, and so on. On the other hand, because of the variety of drugs and the complexity of active groups, the requirements for packaging materials and containers in direct contact with them are much higher than those for other products