This article mainly introduces several new materials that are currently attracting attention in the field of pharmaceutical packaging materials. Because they have excellent packaging properties, or meet the requirements of environmental protection and non-toxic, or have the characteristics of convenient and safe use, they have received increasing attention.
The first major category of products is composite hardsheets made of aluminum-plastic blister packs and convenient materials for cold stamping molding materials. Among them, composite hard sheets can be divided into PVDC composite hard sheets and PP hard sheets. Aluminum plastic blister packaging is a widely accepted form of packaging. As we all know, its outstanding advantage is that the medicines are individually packaged for convenience and safety. Blister molding materials used in the production of aluminum-plastic blister packaging products mainly used PVC hard sheets. With the continuous improvement of the barrier requirements for packaging materials for pharmaceuticals and the increasing demand for environmentally friendly products that are environmentally friendly, some new types of products that replace PVC rigid films have emerged. There are mainly PVDC hard sheets, PP hard sheets and cold stamping molding materials.
PVDC hard sheet is mainly composed of PVC hard sheet and another kind or several kinds of polymer film and sheet, and the composite material produced through extrusion, compounding, coating and other preparation processes. This type of material combines the rigid and well-formed characteristics of PVC hard sheets. It can be used in PTP aluminum-plastic blister packaging, and it also has excellent barrier properties to water vapor, oxygen, carbon dioxide, and various odors, which can satisfy the deliquescence and easy Oxidation drug packaging requirements, and acid, alkali, grease, solvent resistance.
PVDC hard sheet products specifically include PVC/PE/PVDC composite hard sheets, PVC/PVDC composite hard sheets, etc. The current national standards for the implementation of the above two products are YBB00202002 and YBB00222002, respectively. Take PVC/PVDC composite hard film as an example, the production process is to put the PVC hard film first, carry out gluing, then apply PVDC emulsion, cut and test after the drying and curing process, and finally pack into the warehouse.
With the concept of environmental protection becoming more and more popular, the modified PP film has gradually become a popular new material in the field of drug packaging materials in the world. It is non-toxic, harmless, recyclable and recyclable, and is an unmatched advantage of PVC film. . In addition, PP hard film also has good transparency, stiffness and appearance, excellent processing performance; it also has strong barrier properties against various gases and moisture, and also has resistance to acids, alkalis, greases, etc. Greatly improved, these features make the application of PP very good.
Cold stamping molding material is another kind of material suitable for blister packaging, and because it does not require preheating in the molding process, it saves energy and is an ideal alternative to thermoformed blister packaging materials. It was first developed in Europe in the 1980s and consists of a base material and a capping material. The base material is a deep-stretched flexible aluminum-plastic composite film, which is mainly divided into three layers. That is, the outer layer of the plastic film plays an auxiliary extension role; the middle layer of the soft aluminum material acts as a barrier; the inner layer of the plastic film plays a role of heat sealing. The capping material is heat sealed PTP aluminum foil or aluminum plastic composite film.
In addition to the excellent barrier properties of PVDC and PP rigid sheets, the cold stamping molding material also has the characteristics of UV resistance, easy setting of anti-counterfeiting marks, good mechanical stability, easy filling, easy opening, and suitable geographical span. Big advantage. The most widely used abroad now is the DDS drug delivery system and cover films used to protect children and the elderly. The products that have been listed in China's national standards catalog include polyamide/aluminum/polyvinyl chloride (PVC) cold stamping forming solid pharmaceutical composite hard sheets. The main production process is to use polyamide as the substrate for printing on a plastic gravure printing machine and then coating. Glue, hot bake, composite Al, then glue, hot bake after composite PVC, and finally curing, cutting. In the national standard number YBB00242002, the main safety indicators controlled by the product include barrier properties, peel strength, heat seal strength, vinyl chloride monomer, dissolution test, microbial limit, and abnormal toxicity.
The second largest category of new packaging materials is non-PVC co-extruded infusion membranes for intravenous large volume injection and infusion bags made of it. The development of the infusion container experienced from the earliest open wide-mouth glass bottles, semi-open glass bottles, semi-open plastic bottles, fully-enclosed PVC soft bags to the latest fully enclosed non-PVC co-extruded film Soft bag. The most significant advantage of a fully enclosed infusion container is that it does not require the introduction of outside air to form a circuit during the infusion process, thereby avoiding secondary contamination of the infusion product. Especially when infusion is performed in a place with a poor medical environment, safety is improved. The same as a fully enclosed infusion container, the soft bag made of non-PVC co-extruded film is undoubtedly due to its advantages in environmental protection and it does not contain the controversial plasticizer DEHP, thus the momentum of development in recent years is better . In addition, non-PVC co-extruded film made of soft bags also have a better transparency, barrier properties, especially water-blocking performance is better than PVC, can be sterilized at 121 °C and biological, chemical inert and so on.
The main structure of non-PVC coextruded film can generally be divided into four parts, namely the outer surface layer, the inner surface layer, the middle layer and the adhesive layer. The outer surface layer is easy to print, has good rub resistance and heat sealability; the inner surface layer is good in heat sealability and good in compatibility with the drug; the middle layer is good in barrier property and softer; the adhesive layer is used to optimize the adhesive properties between different layers. Its production generally uses a multi-layer co-extrusion blow molding process. First, the various pellets are extruded through a plurality of extruders to form a bubble through a circular die, cooled by a water bath or an air-cooled ring, and then passed through an air bubble stabilizer and a herringbone plate to be wound and then extruded. During the process, the inside of the tube membrane is filled with clean grade 100 filtered air to ensure that the coextruded film produced can be directly used for infusion product filling.
Finally, introduce new members in rubber products. The use of rubber stoppers for pharmaceutical packaging has a long history, and the natural rubber plugs of its veteran products will soon be withdrawn from the stage of history in China. Since the development of rubber plugs, the safety of use caused by the quality of rubber plugs has always been the focus of attention of such products. There are mainly puncture and chipping performances of rubber plugs, particle contamination caused by rubber stoppers, and compatibility issues between rubber stoppers and drugs. As countries around the world continue to work on this series of issues, new members of the rubber plug family came into being. Here, we briefly introduce to you the three types of products, which are aimed at solving the above three problems. They are thermoplastic rubber products, coated rubber plugs or coated rubber plugs and disposable rubber plugs.
Thermoplastic rubber polymer (TPE) is a new type of artificial rubber material and a new injection molding process. It has the characteristics that general rubber products do not have. The main process is thermoplastic rubber manufacturing process does not produce chemical crosslinking, no vulcanization process; The finished product has the advantages of high elasticity and high flexibility; when puncturing, it is not easy to drop chips and the puncture performance is improved.
The wash-free rubber plug overcomes a large number of cleanings and the cleaning process is too intense, resulting in the destruction of the molecular structure of the rubber plug surface, and at the same time reducing the loss of the rubber plug particles. Disposable rubber plugs are cleaned, siliconized and dried in rubber plug production enterprises. They are cooled in a 100-class clean environment, packaged in sterilizable bags, and placed directly into steam sterilization. Pharmaceutical companies do not need to clean their products when they are in production and use. They just need to sterilize the rubber plugs to get on the machine.
The main purpose of the development of coated rubber plugs or coated rubber plugs is to isolate the direct contact between the rubber and the drug, to avoid the influence of rubber on the drug components, and to improve the compatibility between the rubber plug and the drug. Commonly used coating materials are polytetrafluoroethylene, polyethylene, polypropylene and the like.
With the rapid development of modern science and technology, there will undoubtedly be more and more new materials in the field of pharmaceutical packaging. The protective function of packaging containers for pharmaceuticals will continue to increase, and the compatibility issues between pharmaceuticals and packaging materials will be further improved. solve.
The first major category of products is composite hardsheets made of aluminum-plastic blister packs and convenient materials for cold stamping molding materials. Among them, composite hard sheets can be divided into PVDC composite hard sheets and PP hard sheets. Aluminum plastic blister packaging is a widely accepted form of packaging. As we all know, its outstanding advantage is that the medicines are individually packaged for convenience and safety. Blister molding materials used in the production of aluminum-plastic blister packaging products mainly used PVC hard sheets. With the continuous improvement of the barrier requirements for packaging materials for pharmaceuticals and the increasing demand for environmentally friendly products that are environmentally friendly, some new types of products that replace PVC rigid films have emerged. There are mainly PVDC hard sheets, PP hard sheets and cold stamping molding materials.
PVDC hard sheet is mainly composed of PVC hard sheet and another kind or several kinds of polymer film and sheet, and the composite material produced through extrusion, compounding, coating and other preparation processes. This type of material combines the rigid and well-formed characteristics of PVC hard sheets. It can be used in PTP aluminum-plastic blister packaging, and it also has excellent barrier properties to water vapor, oxygen, carbon dioxide, and various odors, which can satisfy the deliquescence and easy Oxidation drug packaging requirements, and acid, alkali, grease, solvent resistance.
PVDC hard sheet products specifically include PVC/PE/PVDC composite hard sheets, PVC/PVDC composite hard sheets, etc. The current national standards for the implementation of the above two products are YBB00202002 and YBB00222002, respectively. Take PVC/PVDC composite hard film as an example, the production process is to put the PVC hard film first, carry out gluing, then apply PVDC emulsion, cut and test after the drying and curing process, and finally pack into the warehouse.
With the concept of environmental protection becoming more and more popular, the modified PP film has gradually become a popular new material in the field of drug packaging materials in the world. It is non-toxic, harmless, recyclable and recyclable, and is an unmatched advantage of PVC film. . In addition, PP hard film also has good transparency, stiffness and appearance, excellent processing performance; it also has strong barrier properties against various gases and moisture, and also has resistance to acids, alkalis, greases, etc. Greatly improved, these features make the application of PP very good.
Cold stamping molding material is another kind of material suitable for blister packaging, and because it does not require preheating in the molding process, it saves energy and is an ideal alternative to thermoformed blister packaging materials. It was first developed in Europe in the 1980s and consists of a base material and a capping material. The base material is a deep-stretched flexible aluminum-plastic composite film, which is mainly divided into three layers. That is, the outer layer of the plastic film plays an auxiliary extension role; the middle layer of the soft aluminum material acts as a barrier; the inner layer of the plastic film plays a role of heat sealing. The capping material is heat sealed PTP aluminum foil or aluminum plastic composite film.
In addition to the excellent barrier properties of PVDC and PP rigid sheets, the cold stamping molding material also has the characteristics of UV resistance, easy setting of anti-counterfeiting marks, good mechanical stability, easy filling, easy opening, and suitable geographical span. Big advantage. The most widely used abroad now is the DDS drug delivery system and cover films used to protect children and the elderly. The products that have been listed in China's national standards catalog include polyamide/aluminum/polyvinyl chloride (PVC) cold stamping forming solid pharmaceutical composite hard sheets. The main production process is to use polyamide as the substrate for printing on a plastic gravure printing machine and then coating. Glue, hot bake, composite Al, then glue, hot bake after composite PVC, and finally curing, cutting. In the national standard number YBB00242002, the main safety indicators controlled by the product include barrier properties, peel strength, heat seal strength, vinyl chloride monomer, dissolution test, microbial limit, and abnormal toxicity.
The second largest category of new packaging materials is non-PVC co-extruded infusion membranes for intravenous large volume injection and infusion bags made of it. The development of the infusion container experienced from the earliest open wide-mouth glass bottles, semi-open glass bottles, semi-open plastic bottles, fully-enclosed PVC soft bags to the latest fully enclosed non-PVC co-extruded film Soft bag. The most significant advantage of a fully enclosed infusion container is that it does not require the introduction of outside air to form a circuit during the infusion process, thereby avoiding secondary contamination of the infusion product. Especially when infusion is performed in a place with a poor medical environment, safety is improved. The same as a fully enclosed infusion container, the soft bag made of non-PVC co-extruded film is undoubtedly due to its advantages in environmental protection and it does not contain the controversial plasticizer DEHP, thus the momentum of development in recent years is better . In addition, non-PVC co-extruded film made of soft bags also have a better transparency, barrier properties, especially water-blocking performance is better than PVC, can be sterilized at 121 °C and biological, chemical inert and so on.
The main structure of non-PVC coextruded film can generally be divided into four parts, namely the outer surface layer, the inner surface layer, the middle layer and the adhesive layer. The outer surface layer is easy to print, has good rub resistance and heat sealability; the inner surface layer is good in heat sealability and good in compatibility with the drug; the middle layer is good in barrier property and softer; the adhesive layer is used to optimize the adhesive properties between different layers. Its production generally uses a multi-layer co-extrusion blow molding process. First, the various pellets are extruded through a plurality of extruders to form a bubble through a circular die, cooled by a water bath or an air-cooled ring, and then passed through an air bubble stabilizer and a herringbone plate to be wound and then extruded. During the process, the inside of the tube membrane is filled with clean grade 100 filtered air to ensure that the coextruded film produced can be directly used for infusion product filling.
Finally, introduce new members in rubber products. The use of rubber stoppers for pharmaceutical packaging has a long history, and the natural rubber plugs of its veteran products will soon be withdrawn from the stage of history in China. Since the development of rubber plugs, the safety of use caused by the quality of rubber plugs has always been the focus of attention of such products. There are mainly puncture and chipping performances of rubber plugs, particle contamination caused by rubber stoppers, and compatibility issues between rubber stoppers and drugs. As countries around the world continue to work on this series of issues, new members of the rubber plug family came into being. Here, we briefly introduce to you the three types of products, which are aimed at solving the above three problems. They are thermoplastic rubber products, coated rubber plugs or coated rubber plugs and disposable rubber plugs.
Thermoplastic rubber polymer (TPE) is a new type of artificial rubber material and a new injection molding process. It has the characteristics that general rubber products do not have. The main process is thermoplastic rubber manufacturing process does not produce chemical crosslinking, no vulcanization process; The finished product has the advantages of high elasticity and high flexibility; when puncturing, it is not easy to drop chips and the puncture performance is improved.
The wash-free rubber plug overcomes a large number of cleanings and the cleaning process is too intense, resulting in the destruction of the molecular structure of the rubber plug surface, and at the same time reducing the loss of the rubber plug particles. Disposable rubber plugs are cleaned, siliconized and dried in rubber plug production enterprises. They are cooled in a 100-class clean environment, packaged in sterilizable bags, and placed directly into steam sterilization. Pharmaceutical companies do not need to clean their products when they are in production and use. They just need to sterilize the rubber plugs to get on the machine.
The main purpose of the development of coated rubber plugs or coated rubber plugs is to isolate the direct contact between the rubber and the drug, to avoid the influence of rubber on the drug components, and to improve the compatibility between the rubber plug and the drug. Commonly used coating materials are polytetrafluoroethylene, polyethylene, polypropylene and the like.
With the rapid development of modern science and technology, there will undoubtedly be more and more new materials in the field of pharmaceutical packaging. The protective function of packaging containers for pharmaceuticals will continue to increase, and the compatibility issues between pharmaceuticals and packaging materials will be further improved. solve.
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