Discussion on Pharmaceutical Packaging Materials and Equipment

Blister packaging blister, cavity, disk box, etc. are of large or small, shapes vary depending on the shape of the packaged items; useful substrates, there is no substrate; and there are many types of blister packaging machine, bubble There are also a variety of cover packaging methods. In spite of this, the basic principles of blister packaging are generally the same, the typical process of which is:

Plastic Sheet Heating → Film Forming → Filling Products → Covering Substrate → Heat Sealing → Trimming

After completing the above process, manual operation, semi-automatic operation and automatic operation can be used.

Since the blister packs of pharmaceuticals have large production batches, relatively fixed varieties, and require safety and health, it is advisable to use automated packaging lines for production. When automated operations are performed, in addition to the completion of the packaging operations, printing, assembly instructions, and packaging can be performed. : The process is connected to the packaging line to form a fully automated blister packaging line.

(a) Reel plastic sheeting is forwarded;

(b) The sheet is heated and softened, and the blister is formed by compression molding (using compressed air) or blister (using vacuum) within the mold;

(c) Filling the product with an automatic feeding mechanism;

(d) To inspect the quality of blister forming and whether the filling is qualified; in automatic production lines, photoelectric detectors are often used. When unqualified products are found, the waste signals are sent to the memory device. After the punching process is completed, the waste products are automatically removed.

(e) Reel substrate material covering the filled blister;

(f) using a plate or roll heat sealer to seal the blister with the substrate;

(g) Print batch number, date, etc. on the back of the substrate;

(h) Punching into individual packaging units. After rejecting the waste equipment, after the flushing process is completed, reject the waste according to the signal stored in the memory device.

(j) Installation instructions, cartoning, sales packages.

Second, the pharmaceutical packaging material Division

The materials used for pharmaceutical blister packs include plastic sheets, substrate materials, heat-sealable coating materials, and substrate printing inks.

1. Plastic sheet material

The commonly used hard plastic sheets for pharmaceutical blister packaging are polyvinyl chloride, polyvinylidene chloride, and some composite materials. At present, the largest application volume is PVC hard sheets.

Rigid polyvinyl chloride sheet has good transparency and gloss. Polyvinyl chloride sheets used for pharmaceutical packaging have high requirements on the hygienic requirements of resins, and non-toxic polyvinyl chloride resins, non-toxic modifiers, and non-toxic heat stabilizers must be used.

Polyvinylidene chloride has high polymer density, regular structure, high crystallinity, strong gas tightness, excellent moisture resistance, good resistance to oil, chemicals and solvents, and oxygen in the air. Water vapor and carbon dioxide gas have excellent barrier properties. Compared to materials of the same thickness, the barrier properties of polyvinylidene chloride to oxygen are 1500 times that of polyethylene, 100 times that of polypropylene, and 100 times that of polyester. Water vapor and oxygen are superior to polyethylene. And polyvinylidene chloride material sealing performance, impact strength, durability and other indicators of tensile strength can meet the special requirements of drugs and other blister packaging. Therefore, polyvinylidene chloride is one of the directions for the development of blister packaging materials. Composite plastic hard sheets for pharmaceutical blister packaging are PVC/PVDC/PE, PVDC/OPP/PE, PVC/PE, etc. Packaging requires barrier and light-proof pharmaceuticals, and may use plastic flakes and aluminum foil composite materials, such as PET/ Aluminum foil / PP, PET / aluminum foil / PE composites.

2. Substrate material

The blister packaging substrate for tablets and capsules is usually coated with aluminum foil. The aluminum foil is made of electrolytic aluminum with a purity of 99%. After being calendered, the aluminum foil has a highly dense metal crystal structure, which is nontoxic, odorless, and has excellent shading. It has extremely high moisture-proof, gas-barrier, and taste-protecting properties, can protect the packaged object most effectively, and is widely used in pharmaceutical blister packaging. The surface of the substrate should be neat and glossy, printability is good, and the heat seal coating can be firmly coated to ensure that the heat seal coating is melted and the substrate and the blisters can be tightly combined together.

3. Heat seal coating material

The heat seal coating should be compatible with the substrate and the blister, requiring that the heat seal temperature be relatively low so that the heat seal can be quickly sealed without damaging the blister film. At present, the heat-sealable coating materials used in pharmaceutical blister packs are mainly divided into single-component adhesives and two-component adhesives. One-component adhesives are mainly composed of natural rubber or synthetic rubber, and nitrocellulose and acrylic esters. They have non-dry and hot-melt properties and have a certain adhesive strength. Two-component adhesives are mainly polyurethane adhesives, which have good resistance to high and low temperatures, resistance to media erosion, and high adhesive force, and can simultaneously act as a bonding agent for a variety of materials. Has been widely used in the substrate aluminum foil coating adhesive and various types of plastic film in the composite process. Other commonly used heat seal coating materials are solvent-resistant vinyl resins and water-resistant acrylic resins, all of which have good gloss, transparency and heat sealing properties.

4. Substrate printing ink

Considering the special requirements of the printing process and pharmaceutical packaging of pharmaceutical blister packaging substrate aluminum foil, the printing ink must have good adhesion to aluminum foil, the printed text pattern is firm and clear, the solvent release is good, and the heat resistance is good. Excellent friction properties, good gloss, pigments must be non-toxic, do not contaminate the packaged drugs, practical viscosity should comply with the process requirements of aluminum foil printing. Currently applied to the substrate aluminum foil printing inks are mainly divided into two categories: The first type is alcohol-soluble polyamide inks. Because polyamide resin has good adhesion to various kinds of substances, especially suitable for printing polyolefin films, with good dispersion, good gloss, softness, good abrasion resistance, good solvent release and printing, so Specially used for various surface-printed intaglio printing inks such as LDPE, CPP, OPP, etc., which are specially processed for various plastic films. Such inks are characterized by good gloss, wide application, anti-adhesion, and easy drying, and are also used in pharmaceutical blister packs. Packaging substrate foil printing. The second type of ink is an aluminum foil special ink based on a vinyl chloride-vinyl acetate copolymer resin alkyd resin. Its characteristics are bright color, high concentration, particularly strong adhesion with aluminum foil, good transparency, excellent reproducibility of aluminum foil metal gloss, and by adjusting the composition of its mixed solvent to meet the printing needs of aluminum foil surface, will be more Applied to substrate aluminum foil printing.

Three pharmaceutical blister packaging equipment

1. Blister packaging equipment

Pharmaceutical blister packaging equipment is basically the same as the blister packaging equipment of other products and consists of the following components:

1 heating part. The plastic sheet is heated by a heating device to soften it for molding.

According to the different contact modes between the heater and the sheet, the heating method includes direct heating and indirect heating. Direct heating is the contact between the sheet and the heater, heating speed, but uneven, suitable for heating thin materials; indirect heating is the use of radiant heat, close to the sheet heating, heating thorough and uniform, but the speed is slow, for thick materials Both apply.

According to the different heat sources of the heater, there are heating methods such as hot air flow heating and heat radiation heating. The heating system of hot air is directly sprayed onto the surface of the heated plastic sheet by a high-temperature hot gas flow. In this way, the heating efficiency is not high enough and is not uniform enough; the heat radiation heating utilizes the light radiation and high temperature generated by the far-infrared heater to heat the blank sheet. Heating efficiency is high and uniform.

2 molding part, the molding part can be divided into two types of dental plastic molding and plastic molding. Compression molding is the use of compressed air to soften the sheet pressed into the mold, so that close to the inner wall of the mold to form a blisters, the mold uses a flat shape, usually intermittent delivery, can also be used for continuous delivery, the molding quality is good, the depth of the bubble The hoods are suitable for vacuum molding. The softened sheet is adsorbed on the inner wall of the mold to form a blister. The mold uses a continuous delivery roller shape. Due to the vacuum generated suction is limited, plus the blister after molding The angle of the detachment roller is limited, so it is only suitable for shallow blisters and thinner materials.

3 filling device. Quantitative filling of the drug into the formed blister, multi-column quantitative automatic filling device.

4 heat sealing device. The aluminum foil substrate material used for covering is sealed on the blister, and there are two types, flat plate type and roller type. Plate type for intermittent delivery; drum type for continuous delivery.

2. Classification of Pharmaceutical Blister Packaging Equipment

Blister packaging machines are divided according to the degree of automation, there are two kinds of semi-automatic packaging machines, automatic packaging machines and automatic production lines. The packaging of pharmaceuticals (pills, capsules, suppositories, etc.) mainly uses automated packaging lines, also known as PTP (PressThroughPack) automatic packaging lines. There are two kinds of horizontal and vertical, generally using a multi-column structure, high productivity, good packaging quality. In addition, it has a detection device and a rejection mechanism for rejects, which can connect the printing, distribution instructions, and cartoning processes to the production line. It is a packaging automatic production line with complete packaging functions and typical packaging.