Western medicine tablets are one of the current pharmaceutical dosage forms with a large variety of Zui and a large sales volume. Because the tablet packaging material is in direct contact with the drug, it is a type of drug packaging. As a special commodity, the packaging materials and structural forms of the drug must ensure the efficacy of the drug, and at the same time ensure the reliable and convenient use of the drug. Therefore, when selecting packaging materials, pharmaceutical manufacturers should understand some properties and characteristics of packaging materials and containers in order to combine the special requirements of pharmaceuticals to select pharmaceutical packaging materials fairly and correctly.
Plastic bottle packaging In the 1980s, China began to introduce advanced medicinal plastic bottle production lines from abroad, and opened the curtain of “plastic†on behalf of “glassâ€. The zui medicinal plastic bottle is characterized by light weight, non-fragile, clean and beautiful. The pharmaceutical manufacturer can directly use it without cleaning and drying, and its chemical resistance, water vapor permeability and sealing performance are excellent. The drug is installed to protect the body from safety. The medicinal plastic bottles are made of high density polyethylene bottles (HDPE), polypropylene bottles (PP), polycarbonate bottles (PC), and polyester bottles (PET). In the early 1990s, a new type of polyethylene naphthalate (PEN) plastic bottle for blow molding bottles was developed abroad, which is superior in quality and more widely used than PET.
At present, medicinal plastic bottles have many specifications and different shapes. In the face of the outstanding plastic bottle market, pharmaceutical manufacturers should pay attention to the following principles when choosing plastic bottles:--Select the main raw materials and additives formula of plastic bottles. Generally, tablets are made of high density polyethylene and polypropylene bottles. If you need transparency, you can use PET bottle; if the drug needs higher barrier performance, and block light and opacity, choose brown PET bottle; the barrier performance is good for PEN bottle.
Pay attention to the sealing property and water vapor permeability of the bottle and the cover. Sealability and water vapor permeability are two important technical indicators for pharmaceutical plastic bottles, which have a great impact on drug stability.
Pay attention to the quality standards of plastic bottles. From the product quality standards, the quality of the product can be analyzed and judged.
Investigate the quality assurance system. Auditing suppliers has become an essential part of the procurement of plastic bottles. Through auditing, a comprehensive and correct assessment of the software and hardware facilities, technical equipment and quality level of the production plant can be made.
Detect the stability and compatibility of the plastic bottle. The selection of plastic bottles, especially new drugs using new plastic bottles (or new materials, new processes) should first carry out the charge test to examine the stability of the charge and the compatibility between the plastic bottle and the drug.
Blister packs for blister packs are also known as blister packs. Compared to bottled tablets, blister packs have the advantage of being easy to carry and reducing contamination during drug handling and handling. However, for long-term patients, the unit cost of blister packaging is significantly higher than that of bottled drugs. Therefore, some pharmaceutical companies usually use high-priced, high-tech products and new varieties of drugs in blister packaging. The materials used in this packaging are mainly medicinal aluminum foil and plastic hard tablets (PTP). The medicinal aluminum foil is a sealing material sealed on a plastic hard sheet. It is made of pure industrial aluminum as a base material, and has the characteristics of non-toxic, corrosion-resistant, impervious, heat-resistant, moisture-proof, light-blocking and high-temperature sterilization. Plastic hard sheet materials are usually made of polyvinyl chloride (PVC), polyvinylidene chloride (PVDC) or composite materials, which have good barrier properties against water, steam and light.
If a pharmaceutical company chooses a medicinal aluminum foil packaging tablet product, when signing a PTP aluminum foil purchase contract with the supplier, it must state the relevant technical requirements, such as product name, specification (width and thickness requirements), printing color, and aluminum foil volume text arrangement. Direction and position, aluminum foil structure, adhesive coating amount, coating color requirements, packaging requirements, etc.
There are certain principles for the selection of medicinal plastic hard sheets or composite materials: PVC tablets can be used for ordinary tablet medicines that do not require high moisture resistance; PET can be used for medicines that have moisture and oxidation resistance requirements or have long shelf life requirements. Film, PP hard film.
The choice of hard material should follow a certain procedure: when selecting the polymer hard film according to the nature of the drug and the shelf life requirements, you should consult the technical experts of the pharmaceutical packaging material manufacturer, or conduct material testing, taking full account of the equipment versatility, appearance novelty and cost. Zii low; should be tested on the machine to determine the suitability of the packaging materials for the equipment and the appearance of the product quality; each drug must be tested for stability and compatibility, due to the nature of various drugs; Go to the pharmaceutical packaging materials company to conduct environmental, equipment, process, quality and Other related governance content review, and jointly determine the raw materials, formula, structure and product standards of pharmaceutical packaging materials, the ultimate agreement can be signed.
Strip composite film packaging Some large dosage forms or pharmaceuticals that are sensitive to ultraviolet light, strong in moisture absorption, require heat and cold resistance, and require a long effective period, and require improved packaging grade, should be packaged in strip-shaped composite film, referred to as SP. It uses two layers of medicinal strip packaging film (SP film) to sandwich the tablets in the middle, and the unit medicines are separated by a certain interval. The two layers of SP film around the medicine are heat-sealed and sealed on the strip packaging machine. Tooth marks, formed in unit packaging form (single package or in small packages). This type of packaging requires continuous operation on a strip packer, making it ideal for high volume automated packaging. When taking the medicine, the SP film can be torn along the tooth marks. The strip packaging film has a certain tensile strength and elongation, and is suitable for medicines of various shapes and sizes, and is closely attached to the medicine after packaging, and is not easy to cause cracks and wrinkles. At present, aluminum-plastic composite film is commonly used, such as cellophane and aluminum foil and polyethylene composite (PT/AL/PE), polyester and aluminum foil and polyethylene complex (PET/AL/PE), that is, aluminum foil and plastic film to stick The mixture is laminated or extruded and composed of a base layer, a printing layer, a high barrier layer and a sealing layer, the base layer is outside, the sealing layer is inside, and the high barrier layer and the printing layer are located in the middle. The base material requires excellent mechanical properties, luster, good printability, good transparency, high barrier properties, safe, non-toxic and non-sealing. Typical materials are polyester (PET), cellophane (PT) and PVDC coated. cellophane. The high barrier layer requires good gas barrier properties and moisture resistance, does not penetrate bacteria and microorganisms, has good mechanical properties, has a certain elongation, is resistant to cold and heat, and is safe and non-toxic. The typical material is soft aluminum foil. Soft aluminum foil is generally opaque, does not rust itself, and has strong opacity. If a transparent strip packaging film is required, PVDC should be used as a high barrier material, and its characteristic is that it has excellent barrier properties against gas and water vapor. The sealing layer is the inner layer of the strip-shaped packaging film, has excellent sealing property, and has chemical stability and safety and hygienic properties, and generally adopts low-density polyethylene material.
When a pharmaceutical company chooses a composite film for packaging, it should be determined according to the nature of the drug (moisture, oxidation, taint preservation, etc.) and shelf life. The following points are available for reference:
The composite structure of the ordinary composite film is PET/AL/PE, which is characterized by good printing adaptability and good gas and moisture barrier properties to the medicine.
The composite structure of the medicinal strip-like tear-off composite film is PT/PE/AL/PE, which is characterized by good tearability and convenient for consumers to take products. Its good gas and water vapor barrier properties also ensure a long shelf life of the contents.
The composite structure of the paper aluminum-plastic composite film is paper/PE/AL/PE, which is characterized by good stiffness and is suitable for printing. In addition, it has good barrier properties to gas or water, allowing the drug to have a longer shelf life.
Plastic bottle packaging In the 1980s, China began to introduce advanced medicinal plastic bottle production lines from abroad, and opened the curtain of “plastic†on behalf of “glassâ€. The zui medicinal plastic bottle is characterized by light weight, non-fragile, clean and beautiful. The pharmaceutical manufacturer can directly use it without cleaning and drying, and its chemical resistance, water vapor permeability and sealing performance are excellent. The drug is installed to protect the body from safety. The medicinal plastic bottles are made of high density polyethylene bottles (HDPE), polypropylene bottles (PP), polycarbonate bottles (PC), and polyester bottles (PET). In the early 1990s, a new type of polyethylene naphthalate (PEN) plastic bottle for blow molding bottles was developed abroad, which is superior in quality and more widely used than PET.
At present, medicinal plastic bottles have many specifications and different shapes. In the face of the outstanding plastic bottle market, pharmaceutical manufacturers should pay attention to the following principles when choosing plastic bottles:--Select the main raw materials and additives formula of plastic bottles. Generally, tablets are made of high density polyethylene and polypropylene bottles. If you need transparency, you can use PET bottle; if the drug needs higher barrier performance, and block light and opacity, choose brown PET bottle; the barrier performance is good for PEN bottle.
Pay attention to the sealing property and water vapor permeability of the bottle and the cover. Sealability and water vapor permeability are two important technical indicators for pharmaceutical plastic bottles, which have a great impact on drug stability.
Pay attention to the quality standards of plastic bottles. From the product quality standards, the quality of the product can be analyzed and judged.
Investigate the quality assurance system. Auditing suppliers has become an essential part of the procurement of plastic bottles. Through auditing, a comprehensive and correct assessment of the software and hardware facilities, technical equipment and quality level of the production plant can be made.
Detect the stability and compatibility of the plastic bottle. The selection of plastic bottles, especially new drugs using new plastic bottles (or new materials, new processes) should first carry out the charge test to examine the stability of the charge and the compatibility between the plastic bottle and the drug.
Blister packs for blister packs are also known as blister packs. Compared to bottled tablets, blister packs have the advantage of being easy to carry and reducing contamination during drug handling and handling. However, for long-term patients, the unit cost of blister packaging is significantly higher than that of bottled drugs. Therefore, some pharmaceutical companies usually use high-priced, high-tech products and new varieties of drugs in blister packaging. The materials used in this packaging are mainly medicinal aluminum foil and plastic hard tablets (PTP). The medicinal aluminum foil is a sealing material sealed on a plastic hard sheet. It is made of pure industrial aluminum as a base material, and has the characteristics of non-toxic, corrosion-resistant, impervious, heat-resistant, moisture-proof, light-blocking and high-temperature sterilization. Plastic hard sheet materials are usually made of polyvinyl chloride (PVC), polyvinylidene chloride (PVDC) or composite materials, which have good barrier properties against water, steam and light.
If a pharmaceutical company chooses a medicinal aluminum foil packaging tablet product, when signing a PTP aluminum foil purchase contract with the supplier, it must state the relevant technical requirements, such as product name, specification (width and thickness requirements), printing color, and aluminum foil volume text arrangement. Direction and position, aluminum foil structure, adhesive coating amount, coating color requirements, packaging requirements, etc.
There are certain principles for the selection of medicinal plastic hard sheets or composite materials: PVC tablets can be used for ordinary tablet medicines that do not require high moisture resistance; PET can be used for medicines that have moisture and oxidation resistance requirements or have long shelf life requirements. Film, PP hard film.
The choice of hard material should follow a certain procedure: when selecting the polymer hard film according to the nature of the drug and the shelf life requirements, you should consult the technical experts of the pharmaceutical packaging material manufacturer, or conduct material testing, taking full account of the equipment versatility, appearance novelty and cost. Zii low; should be tested on the machine to determine the suitability of the packaging materials for the equipment and the appearance of the product quality; each drug must be tested for stability and compatibility, due to the nature of various drugs; Go to the pharmaceutical packaging materials company to conduct environmental, equipment, process, quality and Other related governance content review, and jointly determine the raw materials, formula, structure and product standards of pharmaceutical packaging materials, the ultimate agreement can be signed.
Strip composite film packaging Some large dosage forms or pharmaceuticals that are sensitive to ultraviolet light, strong in moisture absorption, require heat and cold resistance, and require a long effective period, and require improved packaging grade, should be packaged in strip-shaped composite film, referred to as SP. It uses two layers of medicinal strip packaging film (SP film) to sandwich the tablets in the middle, and the unit medicines are separated by a certain interval. The two layers of SP film around the medicine are heat-sealed and sealed on the strip packaging machine. Tooth marks, formed in unit packaging form (single package or in small packages). This type of packaging requires continuous operation on a strip packer, making it ideal for high volume automated packaging. When taking the medicine, the SP film can be torn along the tooth marks. The strip packaging film has a certain tensile strength and elongation, and is suitable for medicines of various shapes and sizes, and is closely attached to the medicine after packaging, and is not easy to cause cracks and wrinkles. At present, aluminum-plastic composite film is commonly used, such as cellophane and aluminum foil and polyethylene composite (PT/AL/PE), polyester and aluminum foil and polyethylene complex (PET/AL/PE), that is, aluminum foil and plastic film to stick The mixture is laminated or extruded and composed of a base layer, a printing layer, a high barrier layer and a sealing layer, the base layer is outside, the sealing layer is inside, and the high barrier layer and the printing layer are located in the middle. The base material requires excellent mechanical properties, luster, good printability, good transparency, high barrier properties, safe, non-toxic and non-sealing. Typical materials are polyester (PET), cellophane (PT) and PVDC coated. cellophane. The high barrier layer requires good gas barrier properties and moisture resistance, does not penetrate bacteria and microorganisms, has good mechanical properties, has a certain elongation, is resistant to cold and heat, and is safe and non-toxic. The typical material is soft aluminum foil. Soft aluminum foil is generally opaque, does not rust itself, and has strong opacity. If a transparent strip packaging film is required, PVDC should be used as a high barrier material, and its characteristic is that it has excellent barrier properties against gas and water vapor. The sealing layer is the inner layer of the strip-shaped packaging film, has excellent sealing property, and has chemical stability and safety and hygienic properties, and generally adopts low-density polyethylene material.
When a pharmaceutical company chooses a composite film for packaging, it should be determined according to the nature of the drug (moisture, oxidation, taint preservation, etc.) and shelf life. The following points are available for reference:
The composite structure of the ordinary composite film is PET/AL/PE, which is characterized by good printing adaptability and good gas and moisture barrier properties to the medicine.
The composite structure of the medicinal strip-like tear-off composite film is PT/PE/AL/PE, which is characterized by good tearability and convenient for consumers to take products. Its good gas and water vapor barrier properties also ensure a long shelf life of the contents.
The composite structure of the paper aluminum-plastic composite film is paper/PE/AL/PE, which is characterized by good stiffness and is suitable for printing. In addition, it has good barrier properties to gas or water, allowing the drug to have a longer shelf life.
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