Pharmaceutical blister packaging technology introduction

After the blister pack of the medicine is filled with a medicine through a vacuum suction (bubble) or a molded blister, the aluminum foil is used to cover the material, and the pressure is used to heat seal the foam substrate under a certain temperature and time conditions. Made. Pharmaceutical blister packs, also known as blister packs, are referred to as PTP (Press through Packaging) and are one of the main forms of pharmaceutical packaging. They are suitable for mechanized packaging of solid pharmaceuticals such as tablets, capsules, suppositories, and pills.

The rise of blister packaging in our country

As early as the 1930s, pharmaceutical blister packs first flourished in Europe and slowly steadily progressed to the world. In the early 1970s, pharmaceutical blister machinery and equipment were introduced in China, but blister-packed aluminum foil and other materials still need to be imported. It was only in 1986 that the country began to introduce more advanced aluminum foil printing and coating production lines for the production of blister packaging materials. At that time, the “PTP” aluminum foil production line of Japan Toyo Aluminum Co., Ltd. was jointly introduced by the Guangzhou Pharmaceutical Administration of the State Pharmaceutical Administration. Subsequently, China National Pharmaceutical Industry Corporation and Lianyungang Pharmaceutical Co., Ltd. jointly introduced the “PTP” aluminum foil printing and coating production line of Japan Tokai Metals Co., Ltd., and introduced process technology testing equipment. China's machinery industry is also introducing pharmaceutical aluminum foil printing and coating production equipment in Jinzhou for scale production. At that time, China's "PTP" production raw materials needed to be imported. The annual output was about 420 tons, and most of them were "foil" printed on the surface of aluminum foil in a single color or not printed. In the 1990s, China has been able to manufacture single-color or multi-color aluminum foil printing and coating equipment, and can print color series of pharmaceutical packaging aluminum-plastic products. In addition, “PTP” aluminum foil materials used in blister packaging, aluminum foil printing inks, aluminum foil protective agents, adhesives, PVC plastic hard sheets and other materials have been made domestically, and can meet the needs of the domestic pharmaceutical market, which has been achieved in China. Pharmaceutical packaging materials production license, manufacturing blister packaging materials manufacturers, including film, film, aluminum foil (composite) enterprises 165, have a considerable scale of production, because the blister packaging is the most widely used in the pharmaceutical industry, the fastest growing flexible packaging One of the materials is also the main packaging form of China's pharmaceutical solid dosage forms. From the initial introduction of equipment, technology, and raw materials to the self-sufficiency of today's own manufacturing equipment and raw materials, China has spent nearly two decades and it is expected that by 2010, China's pharmaceutical blister packaging will have faster development.

Pharmaceutical blister packaging materials overview

Aluminium foils for medicines blister packaging: "PTP" aluminum foil has a protective layer/printing layer/aluminum foil layer/printing layer/adhesive layer, and the basic composition must have a protective layer, an aluminum foil layer, and an adhesive layer. Covering materials for blisters are basically aluminum foils. The production of aluminum foils must be completed through joint operations of aluminum foil printers, coaters, slitters, and packaging machines to complete the entire production process.

In the pharmaceutical packaging materials industry, aluminum foils processed and delivered from the factory are often called “original aluminum foils” or “original foils”. The original foils are made of electrolytic aluminum with a purity of 99% or more and are produced by calendering. Aluminum is rich in resources, low in price, and easy to process. When used as a pharmaceutical packaging material, aluminum foil is the only metal material in packaging materials. Aluminum foil is non-toxic, odorless, has excellent electrical conductivity and light-shielding properties, has extremely high moisture resistance, gas barrier and taste protection, and can most effectively protect packaged pharmaceuticals. It is a type that has not yet been replaced. Packaging materials, no matter what kind of vapor-deposited metal film, or coated special film can not completely replace the aluminum foil. In the field of modern packaging and decorating, almost all composite flexible packaging materials that need to be opaque or high barrier use aluminum foil as the barrier layer. Since the aluminum foil has the above advantages and is light in weight, has a certain strength, and has good printability, various characters or patterns can be printed thereon. When made into a blister pack, it can be crushed by using a little pressure during use. The patient is convenient in taking medicine and is convenient to carry. It has been widely used in pharmaceutical solid dosage form packaging and has great development potential.

Pharmaceutical aluminum foil coating protective agent and adhesive

After the pharmaceutical aluminum foil is printed, it is necessary to apply a protective agent on the surface of the aluminum foil and coat the adhesive on the other side. The purpose of applying the protective agent on the surface of the aluminum foil is to prevent the abrasion of the printing ink layer on the surface of the aluminum foil, and at the same time prevent the mechanical ink from being contaminated when the outer layer ink comes in contact with the inner layer adhesive in the winding process. The function of coating the adhesive layer is to allow the aluminum foil and the plastic rigid sheet to heat and bond together so that the medicine can be sealed. Most of the currently used protective agents are solvent-based, and their main chemical components are: nitrocellulose, synthetic resins, plasticizers, cosolvents, and thinners. These components are mixed according to a certain ratio, and the solvent is stirred by the reaction vessel to mechanically coat the surface of the aluminum foil to produce a protective film. The specific requirements for medicinal aluminum foil protective agents are: good adhesion and flexibility with aluminum foil, good transparency, good gloss, good heat-resistant solvent volatility, no residual odor, protection of ink layer does not fall off, and resistance Highly abrasive.

At present, the application of pharmaceutical aluminum foil adhesives, adhesive pressure-sensitive adhesives, or single-component adhesives, the main ingredient is natural rubber or synthetic rubber, can also be used nitrocellulose fiber, acrylic resin plus solvent Blended. As the main agent is a macromolecule elastomer, and a tackifier is used as an auxiliary agent, the reaction can be stirred in an organic solvent reaction vessel to be mixed and formed into an emulsion, and has adhesive properties with a plastic hard sheet PVC. The current pharmaceutical blister packaging Most adhesives for aluminum foil use polyurethane adhesives instead of pressure-sensitive adhesives.

Another material used for pharmaceutical blister packs is polyvinyl chloride plastic sheet: polyvinyl chloride, also known as PVC, is the main resin formed by the polymerization of vinyl chloride monomers and is supplemented with materials such as plasticizers, heat stabilizers, and Lubricants, etc., are produced by extrusion or calendered production methods. PVC used for blister packaging is almost always a rolling production process, and PVC films used for composite materials are mostly extruded. Blister plastic materials also use PVC / PVDC (polyvinylidene chloride) composite sheet, PET (polyester), PE (polyethylene), PP (polypropylene) and other materials.

Pharmaceutical blisters mechanized packaging equipment applications

After the aluminum foil material for blister packaging is processed by printing and coating, together with polyvinyl chloride (PVC) plastic hard film, it can be filled with drugs on special blister packaging equipment. Generally, the pharmaceutical company has several units according to its own production capacity. Or dozens of blister packaging machines, from the perspective of currently used blister packaging equipment, the following three types of blister packaging equipment applications are more common.

â—† Roll blister packaging machinery

The process and working principle of the blister packaging machine loading pharmaceuticals: The formed plastic hard sheet PVC is heated and softened to a plastic state by a heating device. After the blister is sucked out by the vacuum negative pressure on the roller forming mold roller, the filling device is filled with the packaged material. Into the blister, and then sealed by a roller type heat sealing device at a suitable temperature and pressure on the single side of the adhesive coated aluminum foil sealed on the blister, the package is sealed in the blister, and then The batch number and the breaking line are marked by the typing and imprinting device at the set position, and finally the packaging plate is punched into a certain size. That is: molding plastic sheet unwinding → heating → plastic forming → material filling → sealing and covering aluminum foil → batch number → pressure breaking line → feed → punching → waste collection.

Hood packaging machine features: molding device structure for the roller type, molding method for plastic molding (negative pressure molding), the use of vacuum to heat the softened plastic molding sheet into the mold cavity cavity to form a certain geometric shape and complete Blister forming. Molding pressure is less than lMpa, forming blister size is small, forming depth is generally within 12mm; blisters package shape is simple, blisters stretch uneven, the top is thinner, the plate is slightly curved. The sealing device structure is a roller type, that is, the material to be sealed passes through between the two rollers that are rotated and is continuously sealed. The line contact is so that the sealing pressure is relatively large, and the sealing quality is easily ensured. Because the use of negative pressure molding, the molding speed is limited, so that production capacity is normal, the number of punching within 45 times / min. Due to roller forming, roller sealing and roller feeding, the blister tape will bend on the roller surface during operation. Therefore, it is not suitable for forming larger, deeper, and more complex blister packages. The volume of the item should also be small.

â—† Flat blister packaging machine

Flat panel blister packaging machine operation process and working procedure: The plastic molding sheet is heated to a softened and plastic state at the flat plate preheating device, and is sent to a flat plate type molding device by a stepping device, and the softened plastic hard sheet is blown with compressed air. Plastic (or stamping and blow molding) into a blister, the filling device will be filled into the blister package, and then transferred to the flat plate sealing device, under the appropriate temperature and pressure, the cover plastic hard sheet and aluminum foil seal Finally, it is sent to the typing, imprinting and punching device, the batch number is printed out, the breaking line is pressed out, and the plate is punched into the specified size. Namely: forming a plastic hard film unwinding → preheating → blow molding → material filling → sealing and covering aluminum foil → batch number → breaking wire break → stepping → punching → collecting waste. In recent years, some medicines need to be protected from light, and a new type of packaging substrate, composite aluminum foil, has emerged. Instead of preheating and compressing air, it is formed by mechanical stretching.

Usage characteristics: The structure of the molding device is flat plate type, the molding method is blow molding (positive pressure molding), and the soft plastic molded hard plastic sheet is blown (or blown and stamped) into the cavity of the molding die using compressed air. Needed geometry blister. Due to the use of positive pressure molding, the molding quality is good, the dimensional accuracy is high, the reproducibility of fine parts is good, the gloss and transparency are good, the blister is beautiful and crisp, the wall thickness is uniform, the size of the forming blister can be larger, and the stretching ratio can be larger. The maximum forming depth of the blister can be more than 35 mm, and the blister can be formed into a complex shape with a molding pressure greater than 4 MPa. The sealing device structure is a flat plate type, and the aluminum foil to be sealed is sent to the flat type sealing plate and then press-closed. After a certain period of time, the aluminum foil is quickly separated, belonging to intermittent sealing, surface contacting, and total sealing pressure required. Large, high precision sealing agencies. Due to the adoption of plate-type molding and panel sealing, the adaptability to changes in plate dimensions is strong and the plates are arranged flexibly. Punched plates are flat and do not warp. But the sealing time is relatively long, so that the speed of the whole machine is reduced, and the number of general punching is within 35 times/minute. The filling space of this type of machine is large, and multiple filling machines can be arranged at the same time. It is easier to realize the packaging of multiple drugs for one plate, expanding the scope of packaging and improving the packaging grade.

â—† Roll plate blister packaging equipment

Roller-type blister packaging machine is evolved from roll-type and flat-type blister packaging machines. Its operation process and working conditions are basically the same as those of the above two packaging machines. The main features are: the structure of the heating device is a flat plate structure. The molding method is blow molding, ie positive pressure molding. The sealing device structure is a roller-type aluminum foil conveying method which is intermittent-continuously combined. The structure of this type of machine is between roller and plate type packaging machines. The process route is generally arranged in a serpentine shape, which makes the overall layout compact, coordinated, moderate in size, easy to observe and operate, and easy to replace the mold, fast, and adjust Fast and reliable. Due to the use of roller-type continuous sealing, the relationship between the molding mechanism and the punching and cutting mechanism is well coordinated and the packaging efficiency can be greatly improved. In general, the punching frequency of such a machine can be up to 100 times per minute or more.

Roll plate blister packaging equipment combines two major advantages of plate forming and roller sealing, so it is widely used, can pack a variety of specifications of sugar-coated tablets, plain tablets, capsules, capsules and shaped tablets, can also be used for packaging Small foods such as chocolate beans and bubble gum, but generally large tablet medicines, capsules, and shaped tablets larger than 16 mm in diameter are not suitable for such packaging equipment when the angle of oblique rows on the plate exceeds 45 degrees.