Pharmaceutical packaging testing project

Packaging----An important guarantee for the quality of drugs

The pharmaceutical industry is a high-tech industrial group that integrates multi-disciplinary advanced technologies, and its impact involves various aspects such as national health, social stability and economic development. According to the data, the pharmaceutical industry has maintained a high growth rate of more than 18% in the past three years. The fly in the ointment is that the successive drug safety incidents in recent years have slowed down the development of the pharmaceutical industry. The incident of zui's recent injections was contaminated by bacteria, which made everyone pay more attention to the quality of drugs. Quality is the foundation of a production enterprise, and the pharmaceutical industry is such a special and key industry. The quality of medicine is a key link that cannot be relaxed at all times.

As a pharmaceutical company, the first thing to focus on is the pharmaceutical ingredients. However, many pharmaceutical companies despise all aspects of the drug development and production will have an impact on its quality, and some factors may cause the drug to deteriorate or even produce toxins. To sum up, after the production of drugs, the quality of drugs is mainly caused by the drug storage environment. The main problems with the deterioration of drugs in this process are these five aspects: temperature, humidity, air, light, and time. So how to control the impact of these five aspects on the quality of the drug, then briefly introduce the monitoring of these five aspects.

First, temperature control.

Whether it is Western medicine or Chinese medicine, temperature changes may cause changes in the physical or chemical properties of the drug, thus affecting the quality of the drug. For western medicine, a slightly higher temperature will denature proteins in vaccine serum, enzyme preparations, biological agents and other drugs to reduce their efficacy; and temperature will cause some sugar-coated tablets and capsules to deform and stick. Traditional Chinese medicine also has a certain range of adaptation to temperature. If the temperature is too high or too low, the quality of traditional Chinese medicine will change. When the temperature is higher than 35 ° C, plants with more fat are more likely to be oiled. If the ambient temperature is too high, it will easily lead to mildew. If the temperature and humidity are combined, it is more likely to cause bacteria and mold to grow in a large amount and the eggs to hatch, so that the Chinese herbal medicine is bad.

For temperature control, the main means at present is to prevent the drug from coming into contact with high-temperature objects or the environment. This should be noted in the transportation, when stored in the warehouse or in the hands of consumers.

Second, humidity control.

Humidity mainly refers to the content of water vapor. The large amount of medicine affected by humidity is “damp”. Western medicine is prone to discoloration, agglomeration, deformation, and rupture. Western medicine can cause decreased efficacy and microbial growth after damp. For example, aspirin is more stable in dry conditions. When it is damp, it will gradually decompose. It not only has a pungent odor, but also has a greater irritation to the stomach. After the contraceptive pill deteriorates, it will lose the effect of contraception. If the Chinese medicine is not properly stored, the packaging is not good, and the moisture in the air is absorbed, the water content will increase, and the medicine will be mildewed and deteriorated. The Chinese herbal medicine will be mildewed. The tablets will loosely rupture, discolor and stick, the drugs will stick to the block, and some will break down and fail.

For humidity control, packaging is one of the key factors for Zui. There are two main reasons for the dampness of the drug in the packaging: the drug packaging material itself has poor barrier properties against water vapor, and the pharmaceutical packaging process is not well controlled.

1, Drug packaging material water vapor barrier control.

The so-called drug packaging material water vapor barrier property is also called the moisture permeability of the drug packaging material, which means that the material blocks the resistance to water vapor transmission. In order to more specifically grasp the barrier properties of the water vapor of the pharmaceutical packaging material, the effective method of Zui is to control by using a moisture permeability detecting instrument for packaging materials.

A, weighing method (cup method)

According to the national zui new "Compilation of Packaging Materials and Containers for Direct Contact with Drugs (Sixth Series)", the test requirements for water vapor permeation of materials are clearly defined. The standard specifies the test temperature (38 ± 0.6) ° C, relative humidity (90 ± 3)%, and the measuring device is a weighing method moisture permeability tester, and determines the water vapor transmission rate of the material under the test conditions. The early weighing method consists of a moisture permeable cup, an analytical balance and a constant temperature and humidity chamber. It is necessary to perform multiple weighing operations manually, which not only cannot guarantee the experimental conditions, but also the accuracy and accuracy are difficult to achieve. In order to further improve the efficiency and quality of testing, at present, Jinan Languang has introduced a fully automatic weighing method for moisture permeability. The equipment is designed and manufactured according to the standard, and the detection resolution has been 0.001. g/m2? 24h, the lower limit also achieved 0.01 g/m2? 24h, can test the high-barrier materials widely used at present. At the same time, the weighing method test is also widely used as a method of statutory arbitration. This user of the drug plant provides reliable data assurance during drug packaging design.

B, electrolytic analysis

In order to meet the needs of the detection of water vapor barrier properties of more types of pharmaceutical packaging materials, and improve the detection method of drug packaging materials in a single detection method, the application technology is relatively backward, etc., the state officially launched GB/T 21529-2008 Determination of water vapor transmission rate of plastic films and sheets The National Standard for Electrolytic Sensors Act was officially implemented on October 1, 2008.

The electrolysis method uses an electrolysis chamber as a humidity sensor. The permeation chamber is divided into a dry chamber and a humidity controlled humidity chamber by a film or a sheet. The water vapor is permeated through the sample from the wet chamber and carried by the carrier gas stream into the electrolysis chamber. The humidity of the carrier gas is measured by the electrolytic chamber and an electrical signal is output, and then the water vapor transmission rate of the available sample is calculated. It is important to note that since the electrolytic analysis method requires calibration using the data of the weighing method, the measured data is in good agreement with the weighing method data.

According to the standard regulations, or the needs of the company's R&D and production, the pharmaceutical company can select the appropriate testing means through the data, so as to ensure that the drug will not be deteriorated due to the insufficient ability of the packaging material to block the water vapor. problem.

2, Drug packaging air tightness control

When dealing with the problem of tightness of pharmaceutical packaging, there are many influencing factors, two of which are Zui as the key and easy to realize, and the sealing performance and sealing strength (heat sealing strength) are two indicators.

A, packaging sealing test

The sealing performance of the package mainly refers to whether the sealing condition of the finished product meets the needs. The commonly used detection method is the negative pressure method, also known as the visual method. This test standard has been implemented by many companies, and the commonly used seal tester is the device for this test method. The operation process is to put the package to be tested into a test container containing distilled water, and vacuum the test container, and the time when the package can maintain airtightness in the presence of internal pressure difference is the sealing performance of the package. An indicator. At present, many pharmaceutical companies are using sealers, and there are many companies producing seals, but how to choose this equipment? When choosing this equipment, Zui needs to pay attention to the sealing condition of the whole equipment, including the airtightness of the intake pipe, the air outlet pipe, the pipe connection, the test container, etc., and the surface looks similar to the sealer, but The price gap is very far away, and most of it is caused by the design and selection of equipment. Therefore, enterprises should consider carefully when selecting these devices. They must not look at the functions of the equipment. They should consider the manufacturer, equipment quality, market utilization rate and other aspects.

In addition, there is a method of sealing detection, which is the positive pressure method, and there are still few domestic applications. At present, domestic manufacturers have introduced equipments of this method. The positive pressure method detects the sealing property and solves the problem that the visual inspection method cannot detect the detection of the open package. In addition, the positive pressure sealing test technology can comprehensively detect the whole or part of the flexible packaging bag such as the flexible packaging bag, the bottle cap, the container and the hose. Leakage and sealing performance. These two detection methods and equipment well meet the inspection requirements for package sealing.

B, packaging seal strength test

Sealing strength mainly refers to detecting the strength of the seal. The equipment used at this time is generally a tensile machine and a heat seal tester.

The rally machine should be the packaging enterprise zui as a familiar testing equipment. Many pharmaceutical companies also use it. In addition, the rally machine is also an indispensable testing tool for many industries, so the manufacturers of rally machines are particularly numerous. At the time of selection, it is necessary to pay attention to the industry applicable to the rally machine. In particular, the quality of the rally machine should be concerned. Because the rally machine is a conventional reciprocating device, the frequency of use is high and the repeatability of the action is large. If the quality is unstable, Caused a lot of problems after sale.

In the laboratory, different materials can be prepared by heat sealing tester, and the sealing samples under different temperatures, time and pressure can be selected with the tensile machine to meet the required materials and heat sealing conditions. The problem that often occurs when selecting the heat seal tester is that the seal heat seal is uneven, which is caused by the defects of the equipment itself, but the occurrence of this problem directly affects the data of the final heat seal strength of the Zui, so it is purchased. The instrument must pay attention to the existence of this problem. Of course, with the popularization of automatic packaging machinery, bag making and filling tend to be the same link, so that not only the heat sealing strength of the material but also the thermal viscosity of the material should be considered.

Third, air control.

For medicines, the deadly killer of zui in the air requires oxygen. Oxygen can oxidize and degrade the drug, which not only reduces the drug's properties, but also causes the drug to produce toxins that cause harm to the human body. Vitamins C, A, D, etc., which are sought after by Ms. Ai Mei, are prone to deterioration due to oxidation. The traditional Chinese medicine also germinates as hyphae and secretes enzymes due to oxygen and mold spores in the air, decomposing and eroding the internal tissues of the drug, causing mildew and failure of the medicinal materials.

For air control, the main thing is to block oxygen from entering the package and reacting with the drug. This solution is similar to humidity control, except that in the choice of pharmaceutical packaging materials, the choice of moisture permeability of the packaging material is replaced by the choice of oxygen permeability. There are two methods for detecting the oxygen permeability of the drug packaging materials, namely the differential pressure method and the isobaric method.

A. Differential pressure method for detecting oxygen permeability of drug packaging materials

According to the state's newly promulgated "Collection of Packaging Materials and Containers for Direct Contact with Drugs (Sixth Series)", the conditions for oxygen permeability testing of pharmaceutical packaging materials should be: (23 ± 2) °C test temperature, test equipment is pressure Differential gas permeation meter.

The differential pressure method is to maintain a pressure difference of 0.1 MPa on both sides of the sample by an auxiliary pressure device, and then detect the amount of change in the pressure on the low pressure side caused by the penetration of the test gas into the low pressure side of the film, and calculate the gas permeation amount of the test gas (GTR). ). Through effective detection methods and testing equipment, it can provide sufficient data description for enterprise R&D and quality control, and also point out some improvement directions for production. Therefore, it is necessary for the pharmaceutical company to fully control the quality of the whole process from the R&D, production, transportation and sales of the drug to the consumer's mouth. It is necessary to use the data for strict monitoring. In this process, the number of links involved in the packaging, the length of time makes the pharmaceutical factory must pay attention to.

B. Isobaric method for detecting oxygen permeability of drug packaging materials

By isostatic method, one side of the sample is a flowing oxygen or oxygen mixed gas, and the other side is a flowing nitrogen with a stable relative humidity. The electricity analysis sensor can measure the amount of oxygen permeating the sample to calculate the material. Oxygen transmission rate. Although the isobaric method can only detect the barrier property of the drug package to oxygen, it has opened up a new field for container barrier detection.

Whether the pressure difference method or the isostatic method is used to detect the oxygen permeability of the material, the purpose is to select a more suitable material to ensure that the quality of the drug remains unchanged. Therefore, in selecting the device, in addition to selecting the appropriate detection method, we must also pay attention to the quality of the device itself. The price of the barrier detection device is not low, and the external conditions and the device itself have a great influence on the detection result. When selecting the supplier, Pay special attention.

Fourth, light control.

When a drug is exposed to light, it can cause color changes or even reduce the efficacy, especially those that are sensitive to light, such as nitroprusside, nimoton, and the like. Some drugs produce toxic substances when exposed to ultraviolet light. Therefore, the selection of packaging materials with good shading effect is an important means to solve this problem. At present, many medicines have selected aluminum-plastic composite film, aluminized film and other materials, which satisfies the requirements of shading. In addition, during transportation and shelf life, avoiding direct sunlight is also a problem that manufacturers must pay attention to, but these need to coordinate with the enterprises in the entire commercial chain to ensure that the drugs can have a good storage before being used by the end consumers. Environment to ensure the quality of medicines.

Fifth, time control.

Time is a factor in the complexity of these factors, because any one of the above factors or a combination of different factors will change the time. Combining all the above factors with the influence of other factors can finally determine the drug storage time. Therefore, the above factors can be monitored by data and laid the foundation for time control. The data is ultimately more realistic and effective than the subjective judgment of people. Therefore, pharmaceutical companies should start to use data to talk in terms of packaging, and use data to ensure that the quality of the drug does not cause problems due to improper packaging.

According to the report of the State Food and Drug Administration, "At present, the overall level of pharmaceutical packaging in China is significantly behind that of developed countries, including the quality of packaging, the quality of packaging materials and the contribution rate of packaging to the pharmaceutical economy are significantly lower than the level of developed countries." "In China's existing pharmaceutical packaging materials production enterprises, mostly township collective enterprises, small scale, low quality of personnel, equipment, technology and management, and unstable product quality are common." It can be seen that pharmaceutical packaging cannot rely on pharmaceutical packaging. Manufacturers, whether in terms of research and development or quality control, pharmaceutical companies must grasp this link, through strict supervision of their own production, strict inspection of packaging supply to ensure the quality of drugs in consumer use.

For more information, please call Zhang Jianbo (), headquarter of Jinan Languang Electromechanical Technology Co., Ltd.

Our company mainly processes and exports Ginger, which is processed and sold throughout the year. The specifications are: 50g, 150g, 200g, 250g, 300g, 350g.The packages are calcium plastic boxes, cartons and mesh bags.Products are exported to Europe, the United States, South Korea, Malaysia, the Middle East and other countries and regions.The company relies on the good prestige and the excellent product quality has won the general customer the high praise, hoped has the export order the customer please to relate with us.In order to establish long-term business relations, mutual benefit and common development.

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