Safety of the hottest plastic drug packaging 0

Safety of plastic drug packaging

packaging materials, especially those that directly contact 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, absorption and adsorption of active drug components, resulting in drug failure, and sometimes serious toxic and side effects. Therefore, before selecting the container material for any drug, it must be tested to confirm that it is suitable for the intended use, and its impact on the stability of the drug must be fully evaluated, as well as the protective effect of packaging on the drug under different environmental conditions

because the packaging of drugs is of great importance in protecting the safety of drugs, at present, pharmaceutical enterprises should choose different packaging materials according to the quality characteristics of drugs. First of all, we should consider the effectiveness and stability (physical, chemical, microbial), airtightness, and no pollution. In addition, it should have certain strength, heat resistance, cold resistance, light avoidance, convenient disinfection and other functions. In particular, when selecting liquid and powder drugs, we should consider the composition and formula of packaging materials, the different raw and auxiliary materials selected and production processes. Some may be dissolved by the drugs in contact, or interact with drugs, or directly affect the safe use of drugs due to long-term immersion and corrosion of drugs. Moreover, some packaging materials have hidden dangers on drug quality and human health. The variety of drugs and the complexity of effective active genes also put forward higher requirements for packaging materials. Therefore, all drug manufacturers should conduct stability tests at all stages of drug preparation development, and comprehensively investigate the factors related to packaging

the flexible packaging materials of drugs mainly include polyethylene, polypropylene, polyester, polyamide and other polymer materials. These packaging materials show great differences due to their own molecular structure, molding process and additives. Therefore, it is particularly important for drug manufacturers to choose a packaging material suitable for their products, otherwise there will be problems such as drug safety

in order to maintain the safe and hygienic supply of drugs to consumers during the circulation process, the safety inspection of drug packaging must be carried out. It mainly includes the following aspects:

(1) solvent residue

packaging molding generally needs to go through blow molding, printing, compounding and other processes, which are applied by servo motors and real-time load preservation. In order to improve printability and speed up printing speed, some solvents are generally added. After the "Lanzhou incident", the problem of solvent residue has increasingly become the focus of packaging safety. The national standard stipulates that the solvent residue should be less than 10mg/m2, the enterprise standard is generally higher than the national standard, and the total amount is less than 7mg/m2. For the problem of solvent residue, gas chromatograph can be used for detection and control

(2) barrier property

barrier property includes gas barrier and water barrier. Most of the reasons for the deterioration of drugs are due to the inappropriate barrier property of the selected materials. The selection of materials should be based on different bags, shelf life, storage conditions and other appropriate barrier materials

(3) tensile properties

the film is subjected to mechanical tension during packaging and external forces such as extrusion during transportation, which requires that the film must have sufficient tensile strength. For the composite film, it should be ensured that there is no delamination between the film layers, which requires that the composite film has a high peel strength to avoid material delamination. Electronic tensile machine can be selected to control the tensile properties and peeling properties. The national health and Family Planning Commission issued 53 series of national food safety standards for food contact materials and products at the end of 2016

(4) film smoothness

the film surface should have good smoothness to ensure its smooth high-speed packaging. It should be measured according to GB 10006 (method for measuring the friction coefficient of plastic film and sheet). Generally, the dynamic friction coefficient of the film surface is required to be 0 4. Special attention should be paid here, With the increase of temperature "survival by quality", the surface properties of materials will change greatly. Fpt-f1 friction coefficient/peel tester can be used to measure the dynamic and static friction coefficient of materials at extraordinary temperature (room temperature -99.9 ℃).

(5) Heat sealing performance

the filling speed of modern filling machines is getting higher and higher, and problems such as missing sealing, virtual sealing, sticking sealing head, wiredrawing, sealing fracture are more likely to occur in the sealing process, which requires that the heat sealing temperature, heat sealing time and heat sealing pressure of the heat sealing machine be tested and confirmed before automatic packaging, so as to improve efficiency and avoid waste

(6) ink performance

in addition to the general substrate adhesion and wear resistance, the requirements of drug packaging film on ink should also be able to meet the requirements of sterilization and boiling treatment, as well as frost resistance and heat resistance, so as to ensure that the ink will not fall off and coagulate during transportation and storage. It can be tested according to GB 7707 with a printing combination fastness tester

reprinted from: Global flexible packaging industry