Promising application prospects
Medical plastic packaging film is widely used, not only for tablet, powder, granular drug packaging, but also for lining of paste, liquid and pharmaceutical carton packaging, as well as medical equipment packaging. Film, multilayer composite film, etc. In pharmaceutical packaging, glass bottles and plastic bottles that have been used in the past are gradually being replaced by plastic films, especially medical liquid plastic flexible packaging such as infusion bags and plasma bags.
According to a survey conducted by the US industrial market research company Freedonia Grouplnc., the global pharmaceutical packaging demand grew at an average annual rate of 4.3% from 1997 to 2007 (see Table 1). According to the British market intelligence organization's research on the European pharmaceutical packaging market, the total annual sales of the European packaging market is 3.246 billion US dollars, and medical packaging film and bags account for 28%.
The annual output value of China's pharmaceutical packaging industry is about 15 billion yuan, with an average annual growth rate of more than 10%. In recent years, the proportion of plastic products used in medical packaging in China is rapidly increasing. According to the data, the proportion of aluminum and plastic packaging for pharmaceutical tablets in China has increased from 10% in 1990 to 40% today. Medical plastic film has become a new development hotspot for thin films. It is estimated that the demand for plastic packaging for pharmaceutical tablets and capsules in China will increase to 4 billion in 2005.
There are many kinds of medical plastic films. The most widely used ones are PE, PP, PET, PEN (polyethylene naphthalate) PA, PVA, PVC, PVDC, PC and newly developed cyclic olefin copolymer (COC). Etc., where the amount of polyolefin is the largest.
Raw materials are diversified
1, PE
According to Mastio's research report 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 plastic film will increase at an average annual rate of 7% in the next few years. The largest potential growth market for PE medical films is the packaging of anti-infective medical products, followed by disposable liners, small bags and films for medical device packaging. At present, there are more than 40 companies in the world producing medical PE packaging products. The top five companies are Clopay (GriffonCorp), P1iant, Maxxin Medical Products, Rexam Medical Packaging and Banta Health, which have a market share of about 50%. .
Among the PE medical films, the fastest growing amount is LLDPE. In 2003, the amount of LLDPE medical film accounted for 52% of the total market consumption of PE medical film, 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 a film with higher strength than LDPE at the same thickness, thereby making a thin film, saving raw materials and reducing cost.
In recent years, the annual output of LDPE medical film has exceeded 40,000 tons, accounting for 39% of the total dosage, ranking second. HDPE and MDPE are used in small amounts, with a market share below 10%.
2, PP
The metallocene-catalyzed blend of vinyl plastomer and PP can improve the anti-brittleness of the PP film after irradiation, and can be used for packaging 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 believes that if PP is used to make medicinal liquid flexible bags, it needs to combine the high melting point of PP and the elastic block structure of flexible PP. These two materials have excellent softness and flexibility and good. The low temperature toughness and melting point above 121oC, while the density is about 30% lower than PVC, so the unit cost is similar to PVC. According to reports, Montell Catalloy Co., Ltd. and Huntsman's flexible polyolefin FPOs meet the above requirements. Currently, Rxloy products have been produced in the US and Asia, and production licenses have been obtained in Europe. However, the crystallinity of FPOs is 17% to 25% lower than that of PP99%, and it is sticky and difficult to handle. Therefore, it is usually necessary to improve its properties by blending. For example, Adflexks 353 must be used and the density is 0.89 g/cm3. As a surface layer to ensure its strength and melting point above 121oC, the surface layer needs to use a special resin with a high transparency level to provide the required transparency. In addition, the co-extrusion process can overcome the shortcomings of the PP surface haze, and the PP heat-sealing performance can be improved by the formula design. The PP resin with a density of 0.89 g/cm3 can be used to reduce the thickness and reduce the cost.
Amoco and Stanford University have jointly developed PP elastomers with similar PVC properties. The mLLDPE developed by Exxon and Dow Chemical is also being tested in medical liquid flexible bags with excellent cleanliness, transparency and mechanical properties, as well as the potential cost advantages of thin film thickness reduction. However, the melting point of mLLDPE is low, and it can not be adapted to the disinfection treatment at 121oC for 20min. Therefore, it is mainly used for the collection bag of human excretion fluid. If it is used as an infusion bag or a blood transfusion bag, further modification is needed.
In the development of polyolefin as an alternative material for PVC, the use of special polyolefin resin in the process of sterilization, filling, sealing and use of medical products requires a high cost to become an important reason why polyolefin cannot quickly replace PVC. one. However, PP properties have been gradually improved in recent years by changing processing conditions and using new auxiliaries. In addition, problems related to assembly lines such as heat sealing and sterilization conditions can be solved by equipment improvement. Therefore, PP film can be used in the fourth generation infusion bags and plasma bags is just around the corner.
3, PVC
PVC has good chemical resistance, mechanical properties and electrical properties, but has poor light resistance and thermal stability. The PVC film can be produced by calendering or extrusion blow molding. Since PVC is a heat-sensitive resin and has a high hardness, a soft film and a plasticizer must be added to the soft film processing process. The soft and semi-rigid film can be widely used in medical infusion bags and blood transfusion bags when used in medical applications. When packaging materials, the content of vinyl chloride monomer in PVC resin should be less than 1mg/kg. Non-toxic heat stabilizers and non-toxic and non-migrating plasticizers should be used to ensure the safety of the products. The rigid PVC film can be used as a film for pharmaceutical packaging, and is mostly a transparent or amber film. After filling a small dimple by vacuum forming, the tablet is filled and then compounded with a cover material coated with an EVA heat sealant. In order to improve the heat sealing property with the cover material, the PVC inner layer is also coated with an EVA or PVDC coating.
In recent years, phthalate plasticizers used in PVC flexible packaging have been considered toxic and environmental problems caused by the difficulty in recycling of PVC flexible packaging bags, resulting in serious threats and challenges in use, especially in some European countries. The pharmaceutical packaging market is gradually shrinking.
4, PA
The PA film has strong toughness, good puncture resistance, durability, and chemical resistance. It has a wide temperature range, but has large hygroscopicity and poor heat sealability. Therefore, it is often used as a composite film with polyolefin. Since the good overall performance of the PA film is very suitable for protecting medical devices that have been sterilized during storage and transportation, medical device packaging will be a new application area for PA films.
5, CTEF film
The CTFE film is made of ethylene/chlorotrifluoroethylene copolymer, which has high transparency, flame retardancy and barrier properties; and is excellent. The film has a unique application range - it is still soft below 195.50C, and its melting point is 182~204oC.
6, PET
The biaxially stretched PET film has extremely high mechanical strength and rigidity, high heat resistance, good chemical resistance, excellent transparency and gloss, low water vapor and oxygen permeability, and good taste. And non-toxic. PET film can be used directly in contact with pharmaceuticals, and is often used for the packaging of tablets, especially Chinese medicine tablets.
In addition, because of its high taste and heat resistance, it can be used as a barrier layer in a multilayer composite film to ensure that the tablet does not deteriorate during the effective period. Composite film and coating thin as development trend
The basic requirement of the drug for packaging materials is to prevent the content from deteriorating. The main measures are moisture prevention; gas barrier; light protection, sterilizing and heat sealing. In addition, in order to ensure the quality of the contents and the safety of the filling and packaging, storage and transportation processes, packaging materials are also required to ensure the stability of the contents, heat resistance and the hygienic properties of harmful substances, and also require a certain stretching of the materials. Impact resistance, puncture resistance and tear strength. At present, there is no single-layer film that has the above various functions. Multi-layer composite film or film coated by two-layer or two-layer multi-layer composite and multi-shell composite can be used to complement each other and meet various requirements.
Representative product
â— LDPE can be combined with a variety of polyolefins to make flexible packaging bags, such as the medical liquid packaging bags produced by Howadenkok. The raw material is a copolymer of LDPE and ethylene-alpha olefin. It can withstand high temperature sterilization treatment above 1000C and has good flexibility. The multi-layer composite film made of LDPE, adhesive, PA and other raw materials has similar advantages to PVC and PP and has wide application.
â— PP film can be widely used as the inner and outer materials of medical flexible packaging composite film. BOPP has good transparency, heat resistance and barrier properties and is used for the outer layer of the composite bag. It can be combined with heat-sealing LDPE, EVA, EEA, EAA or aluminum foil to improve the physical and mechanical properties of the composite film. If the BOPP base film is coated with PVDC with excellent moisture resistance and barrier resistance, it can improve its resistance. Gas and moisture barrier properties.
Cast PP film (CPP) has good heat sealing properties, and is mostly used in the inner layer of composite packaging bags. It can be combined with BOPP, PET, OPA and PT after vacuum aluminum plating, and is an important material for pharmaceutical packaging.
â—PVDC coated composite film has been widely used in pharmaceutical packaging, which can play a role in moisture resistance, taste preservation and moisture resistance. At present, the PVDC on the market is actually a copolymer of vinylidene chloride (VDC) and vinyl chloride or acrylic monomer, and the monomer content is usually 75% to 90%. PVDC is widely used as a high-efficiency barrier material because of its transparency, flexibility, oil resistance, chemical resistance, and excellent gas barrier and moisture barrier properties. In high-resistance medical packaging, it is usually used as a coating material. It can coat 2~4/μm PVDC composite film on PP, CPE and PET film, which can make its gas permeability and moisture permeability the most suitable for the manufacture of pharmaceutical foam. A composite packaging bag for a cover film and a low-priced drug such as a granular material or a powder.
â— Vacuum aluminum plating film evaporates aluminum onto various base films under high vacuum, and its aluminum plating layer is thin. At present, PETP, CPP, PT, BOPP, PE and other vacuum aluminized films are widely used in the powder, granule and powder packaging of traditional Chinese medicine. Among them, PETP; CPP; PE vacuum aluminized film is the most widely used. In addition to the characteristics of the plastic base film, the film also has decorative properties and good barrier properties, especially after various aluminum substrates are aluminized, the light transmittance, oxygen permeability and vapor permeability are reduced by several times or Hundreds of times. This thin coating for pharmaceutical products can prevent mildew and moisture deterioration of the drug, and is one of the main development directions of pharmaceutical packaging materials in the future.
• CTFE films are chemically inert and can withstand the intensification of aggressive chemicals that metal, ceramics and other plastics cannot withstand. In addition, the CTFE film has a lower vapor permeability than any other plastic film, and it has no moisture absorption, and it can be compounded with various base materials such as PE, PVC, PET, PA, etc. It can also be sprayed by vacuum spraying (plating). Metal. CTFE films and their composites are mainly used to package tablets and capsules that require high moisture resistance.
2. Recent developments in foreign composite membranes
Multi-layer medical packaging film generally adopts PE/adhesive/PA/adhesive/PE/binder/PA/adhesive/PE9 layer structure, and PP can be used instead of PA. Other structures are the same, the thickness is usually 0.05. ~0.4mm. At present, the number of layers of coextruded films is increasing, and many companies have been able to produce 8 layers, 9 layers or even 11 layers of medical packaging films.
At present, foreign multi-layer composite films for pharmaceutical packaging are mainly developed by food packaging companies in their multi-layer structure food packaging film production line. As early as 1996, Bemis Company merged its smaller pharmaceutical packaging film business with its acquired Perfecseal company to form a pharmaceutical packaging company to produce low-cost multilayer film. At present, Perfecseal has established a special plastic packaging film factory for pharmaceuticals, which produces layers of more than 5 layers.
Canada's Winpak Company has an 11-layer casting process for producing food packaging barrier films. It has been improved to produce 11-layer medical packaging film for PA-containing sterilization bags, which has been successful in the North American market. The company has not disclosed the structure of such a multilayer film to date. The company also produces multi-layer blown film using its original multi-layer co-extrusion blown film line of 8 and 9 extruders, which has been approved for pharmaceutical packaging.
After acquiring the Rexam Health Products Flexible Packaging Company in the United States, Amcor Australia applied multi-layer structured food packaging film technology to the pharmaceutical packaging field. Rexam Health Products Flexible Packaging Company has two 5-layer co-extrusion blown film production lines and a 5-layer co-extruded film test line containing PA, which can produce thin films, such as 3 layers of 0.3mm ion-containing crosslinked polymer. The extruded film was thinned to a 0.25 mm 5-layer film containing PA. Rexam also uses co-extrusion coating technology to produce multilayer composite films, reducing costs.
Wipak, Finland is also a well-known manufacturer of high-tech packaging film. It has been approved by the North American management department and installed a dedicated cast film production line in Europe. This is the world's first clean line of pharmaceutical plastic packaging film.
Due to the large market potential of medical plastic packaging and high profits, there are still many food packaging film companies that are planning to enter the field of pharmaceutical packaging film. The production technology of the multi-layer composite film for medical packaging is the same as that of the food packaging film, and has a multi-layer co-extrusion blow molding method and a multi-layer co-extrusion casting method. Most of the pharmaceutical packaging composite films in North America are produced by co-extrusion blow molding, mainly because of the inherent orientation and high tear strength of the multilayer blown film produced by the process. European pharmaceutical packaging is more commonly produced by co-extrusion casting because of the higher dimensional accuracy of the cast film and the softer film. In addition, the thermoformed film for packaging medical equipment is usually a three-layer co-extruded film of EVA/ion cross-linked polymer/EvA3 layer structure or ion-crosslinked polymer with intermediate layer EvA/mixture as inner and outer layers. The ionomers have high toughness and transparency, but are costly; if thick films and bags are required, the above three composite films are often laminated to form a six-layer composite film, which can fully meet the requirements.
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