The development trend and diversification of medical plastic packaging film
medical plastic packaging film is widely used, not only for the packaging of tablets, powders, granular drugs, but also for the lining of paste, liquid and drug carton packaging, as well as the packaging of medical devices. The commonly used films include shrink film, winding film, multilayer composite film, etc. In pharmaceutical packaging, the glass bottles and plastic bottles used in the past are gradually replaced by plastic films, especially the plastic flexible packaging of medical liquids, such as infusion bags and plasma bags, is developing more rapidly
according to American industrial market research company freedoniagrouplnc The survey shows that the annual average growth rate of global pharmaceutical packaging demand from 1997 to 2007 reached 4.3% (see Table 1). According to the research on the European pharmaceutical packaging market released by the British market intelligence organization, the total annual sales of the European packaging market is $3.246 billion, and the traditional Chinese medicine packaging films and bags account for 28%
the annual output value of China's pharmaceutical packaging industry is about 15billion yuan, with an average annual growth rate of more than 10%. In recent years, the application proportion of plastic products in medical packaging in China is rapidly increasing. Statistics show that the proportion of aluminum and plastic packaging for pharmaceutical tablets in China has increased from 10% in 1990 to 40% at present. Medical plastic film has become a new development hotspot of film. It is estimated that the demand for plastic packaging for pharmaceutical tablets and capsules in China will increase to 4billion in 2005
there are many kinds of medical plastic films, and the widely used ones mainly include PE, PP, pet, pen (polyethylene naphthalate) Pa, PVA, PVC, PVDC, PC and the newly developed cyclic olefin copolymer (COC), among which polyolefin is the largest
diversified development of raw materials
1. Pe
according to the Research Report of mastio on the market situation of PE film, PE medical plastic packaging film is one of the fastest growing varieties of plastic film. It is predicted that the global demand for PE medical plastic film will increase at an average annual rate of 7% in the next few years. The biggest potential growth market of PE medical film is the anti infection medical supplies packaging bag, followed by disposable lining film, small packaging bag and film for medical device packaging. At present, more than 40 companies around the world produce medical PE packaging products. The top five companies are clopay (griffoncorp), P1ant, maxxin medical products, Rexam medical packaging and Banta health care, with a market share of about 50%
among PE medical films, LLDPE has the fastest growth in consumption. In 2003, the consumption of LLDPE medical films accounted for 52% of the total consumption of PE medical films in the market, and it is expected to reach 54% in 2006. The main reason for the rapid development of LLDPE medical film is that it can produce films with higher strength than LDPE under the same thickness, so as to produce thin films, save raw materials and reduce costs
in recent years, the annual output of LDPE medical film has exceeded 40000 tons, accounting for 39% of the total consumption, ranking second. The consumption of HDPE and MDPE is small, and the market share is less than 10%
2, pp
the blend of metallocene catalyzed vinyl plastic and PP can improve the embrittlement resistance of PP film after radiation, and can be used in the packaging of medical devices
in recent years, through the modification of PP, it has made great progress in the development of pharmaceutical liquid packaging bags. After screening the raw materials, buxter company believes that if PP is used to make flexible packaging bags for medicinal liquids, it needs to integrate the high melting point of isotactic PP and the elastic block structure of flexible pp. these two materials have excellent softness and flexibility, good low-temperature toughness and melting point higher than 121oc. At the same time, because their density is about 30% lower than PVC, the unit cost is similar to PVC. It is reported that the flexible polyolefin fpos of montellcataloy copolymer company and Huntsman company have met the above requirements. At present, rxloy products have been produced in the United States and Asia, and production licenses have been obtained in Europe. However, the crystallinity of fpos is 17%~25% lower than that of pp99%, and it has a certain viscosity, which is difficult to deal with. Therefore, it is usually necessary to improve its performance through blending. For example, adflexks353 with a density of 0.89g/cm3 must be used as the surface layer to ensure its strength and melting point above 121oc. The surface layer needs to use a special resin with high transparency level to provide the required transparency. In addition, the shortcomings of high haze on the surface of PP can be overcome by coextrusion process. The heat sealing performance of PP can be improved by formula design. The thickness can be reduced and the cost can be reduced by using PP resin with a density of 0.89g/cm3
Amoco and Stanford University jointly developed PP elastomer with PVC like properties. MLLDPE developed by Exxon and Dow Chemical Company is also being used in medical liquid flexible packaging bags. They have excellent cleanliness, transparency and mechanical properties, and also have the potential cost advantage of thinning the film thickness. However, mLLDPE has a low melting point and cannot be used to disinfect at 121oc for 20 minutes. Therefore, it is mainly used as a collection bag for human excretion. If it is used as an infusion bag and blood transfusion bag, it needs further modification
in the development process of polyolefin as a substitute material for PVC, because medical products require the use of special polyolefin resin in the processes of disinfection, sterilization, filling, sealing, use and so on, the high cost has become one of the important reasons why polyolefin cannot quickly replace PVC. However, by changing the processing conditions and using new additives, the performance of PP is gradually improving in recent years. In addition, problems related to the assembly line, such as heat sealing and disinfection conditions, can be solved through equipment improvement. Therefore, it is just around the corner that PP film can be used in the fourth generation infusion bags and plasma bags
3. PVC
PVC has good chemical resistance, mechanical properties and electrical properties, but poor light resistance and thermal stability. PVC film can be produced by calendering or extrusion blow molding. Because PVC is a heat sensitive resin with high hardness, heat stabilizers and plasticizers must be added during the processing of soft films. Its soft and semi-rigid films can be widely used in medical infusion bags and blood transfusion bags. When used in medical packaging materials, the content of vinyl chloride monomer in PVC resin should be less than LMG/kg, and non-toxic heat stabilizers and non-toxic and non migratory plasticizers should be used to ensure the safety of products. Rigid PVC film can be used as the film for drug packaging, mostly transparent or amber film, which is filled with tablets after vacuum blistering forming small pits, and then compounded with the cover material coated with EVA heat sealing agent. In order to improve the heat sealing with the cover material, the PVC inner layer is also coated with EVA or PVDC coating
in recent years, because the phthalate plasticizers used in PVC flexible packaging are considered toxic and the environmental problems caused by PVC flexible packaging bags are not easy to recycle after use, they have encountered serious threats and challenges in use, especially in some European countries, the PVC pharmaceutical packaging market is gradually shrinking
4, pa
pa film has strong toughness and good puncture resistance, durability and chemical resistance. Its use temperature range is wide, but its hygroscopicity is large, and its heat sealing performance is poor. Therefore, it is mostly used with polyolefins and other composite films. Due to the good comprehensive performance of PA film, it is very suitable for protecting medical devices that have been disinfected during storage and transportation, so medical device packaging will be a new application field of PA film
5. CTEF film
ctfe film is made of ethylene/chlorotrifluoroethylene copolymer, which has high transparency, flame retardancy and permeability; Excellent. The film has a unique application range. It is still soft below - 195.50c, and its melting point is 182~204oc
6. Pet
biaxially stretched PET film has very high mechanical strength and rigidity, high heat resistance, good drug resistance, excellent transparency and gloss, small water and oxygen permeability, and good taste retention and non-toxic. PET film can be directly used in contact with drugs, and is often used in the packaging of tablets, especially traditional Chinese medicine tablets. In addition, because of its high flavor retention and heat resistance, it can be used as a barrier layer in multilayer composite films to ensure that the tablets do not deteriorate within the period of validity
composite film and thin coating are the development trend
the basic requirement of drugs for packaging materials is to prevent the contents from deterioration, and the main measure is to prevent moisture; Gas blockage;: Keep away from light, sterile and heat sealed. In addition, in order to ensure the quality of the contents, it is difficult to adjust the matching gap of the ordinary rib and the safety of the filling, packaging, storage and transportation process. It is also required that the packaging materials ensure the stability, heat resistance, and no migration of harmful substances; At the same time, the material is also required to have certain tensile, impact, puncture and tear strength. At present, there is no single-layer film with the above functions. If the multi-layer composite film or coated film is made of two or more layers of multi-layer composite and multi shell composite, then 1 Adjustment parameters: adjust the displayed values of friction force and experimental force, which can learn from each other and meet many requirements
1. Representative products
LDPE can be compounded with a variety of polyolefins to make flexible packaging bags, such as the medical liquid packaging bag produced by howadenkok company, whose raw materials are LDPE and ethylene-- α Copolymers of olefins. It can withstand high-temperature sterilization treatment above 1000C and has good flexibility. The multilayer composite film made of LDPE, adhesive, PA and other raw materials has the advantages similar to PVC and PP and is widely used
pp film can be widely used as inner and outer layer materials of composite film for medical flexible packaging. BOPP has good transparency, heat resistance and impermeability, and is used for the outer layer of composite bags. The physical and mechanical properties of the composite film can be improved by compounding it with LDPE, EVA, EEA, EAA or aluminum foil with good heat sealing property; If PVDC with excellent moisture and permeability resistance is coated on BOPP base film, its gas and humidity resistance can be improved
cast PP film (CPP) has good heat sealing property and is mostly used in the inner layer of composite packaging bags. After vacuum aluminizing, it can be compounded with BOPP, pet, OPA and Pt. It is an important material for drug packaging
pvdc coated composite film has been widely used in drug packaging, which can play the role of moisture resistance, taste preservation, moisture resistance and so on. At present, PVDC on the market is actually a copolymer of vinylidene chloride (VDC) and vinyl chloride or acrylic monomers, and the monomer content is usually 75% - 90%. PVDC has the characteristics of transparency, flexibility, oil resistance, chemical resistance and excellent gas and moisture resistance. It is a widely used high-efficiency barrier material. In high barrier pharmaceutical packaging, it is usually used as coating material, coating 2~4/μ The composite film of mpvdc can make its air permeability and moisture permeability most suitable for blister packaging film for manufacturing drugs and composite packaging bags for packaging low-cost drugs such as granular materials and powders
vacuum aluminum coating is to evaporate aluminum onto various base films under high vacuum, and its aluminum coating is thin. At present, PETP, CPP and PT are widely used in the outer packaging of powders, granules and powders of traditional Chinese medicine; BOPP; Vacuum aluminized film such as PE. The most widely used is PETP; CPP; PE vacuum aluminum coating. In addition to the characteristics of the plastic base film of the thermal insulation material used in refrigerators, the film also has decorative and good permeability resistance. Especially, after aluminizing various plastic substrates, the light transmittance, oxygen permeability and steam permeability are reduced by dozens or hundreds of times. This kind of thin film used in drug packaging can prevent drugs from mildew, moisture and deterioration, which is one of the main development directions of drug packaging materials in the future
ctfe film is inert in chemical properties and can withstand the erosion of strong chemicals that metals, ceramics and other plastics cannot withstand. In addition, the vapor permeability of CTFE film is lower than that of any other plastic film, without moisture absorption, and it can be mixed with various substrates such as PE and PVC
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