Requirements for labeling and packaging of medicines. Requirements for labeling of medicinal products for medical use and veterinary medicinal products Modern types of packaging of medicinal products

1. Introduction……………………………………………………….page 3

2. Types of packaging medicines, their functions………….page 3-6

3. Selected species packages of dosage forms………………pages 6-8

4. Basic requirements for drug packaging………………………..…page 8-9

5. Modern approaches to drug packaging…………………………pages 9-10

6. Conclusion………………………………………………………..page 11

7. References…………………………………………………………….page 12

Introduction

The production of pharmaceutical packaging is an integral component of the pharmaceutical industry. Packaging has become a very important part of drug production because... innovations in the development of new drugs and new drug delivery systems into the body have reached very high level. Pharmaceutical packaging must meet the increasing requirements for medicines. Packaging for pharmaceutical products and traditional packaging for other products are incomparable. The production of pharmaceutical packaging should be based on scientific research, while traditional packaging is more consumer-oriented.

Due to the unique requirements for pharmaceutical products, drug packaging must ensure that the quality of drugs is maintained during transportation, which will increase their shelf life.

Types of drug packaging, their functions

Packaging means a complex consisting of containers, aids, packaging materials that determine the consumer and technological properties of the packaged product.

There are two types of packaging for medicines: primary packaging (individual) and secondary packaging (group or consumer).

Primary packaging is direct (individual) packaging that helps preserve the product during its sale; is part of the goods and, in general, cannot be transported independently;

Secondary packaging - serves to protect individual packaging and surpasses it in information content; performs protective function in relation to the product and primary packaging and creates conditions for their immunity to external influences.


Primary packaging, depending on the materials used, their mechanical stability and strength, which determine the degree of preservation of goods, is divided into groups and types. For various dosage forms, GOST defines the types of primary packaging and closure material.

Exist the following types primary packaging for medicines (according to GOST 17768-90).

By material: hard, semi-hard, soft.

Rigid packaging:

Metal is used for primary containers: jars, test tubes (for packaging

Tablets, dragees, powders, granules, capsules), aerosol cans, tubes (for ointments, pastes, liniments);

Glass is used for the production of jars, test tubes, vials, bottles (tablets, dragees, powders, granules, capsules, ointments, pastes, liniments, eye drops), ampoules;

The polymer is used for the manufacture of test tubes, cups, jars (they are used for packaging tablets, dragees).

Semi-rigid packaging:

Cardboard is used for the production of boxes, packs (for plasters, herbal medicines);

- polymers are used for the production of syringe tubes (for dosage forms intended for injection); dropper tubes are used for packaging eye drops; contours used for packaging suppositories;

The combined material is used for contour packaging of suppositories, tablets, dragees, capsules, powders, granules, and herbal medicines.

Soft packaging:

Made from polymer, it is used as packaging in the form of bags for powders, granules, patches;

Paper packaging in the form of a bag or wrap is used for packaging dragees, tablets, and herbal medicines.

All types of primary containers and closures for them must be selected depending on the properties, purpose and quantity of medicines, in accordance with the requirements state standards and pharmacopoeial monographs.

Materials used for the manufacture of primary containers and closures must be approved for use by the Ministry of Health Russian Federation.

The packaging must be the same for each series of packaged medicinal products and take them into account physicochemical characteristics:

Medicines that are sensitive to light are packaged in light-proof containers;

Medicines containing volatile, weathering, hygroscopic or oxidizing substances are packaged in jars or bottles sealed with screw caps complete with stoppers or gaskets with sealing elements; plugs with sealing elements; roll-up metal caps complete with plugs or gaskets with sealing elements, roll-up metal caps;

Medicines containing highly volatile, weathering, hygroscopic and oxidizing substances intended for export are packaged in containers sealed with roll-up lids or in other containers that ensure their safety;

Each medicinal product containing a volatile substance or having an odor is packaged separately from the others;

Tablet medicines containing essential oils, before packing into test tubes, wrapped in waxed paper; shock absorber seals when packing tablets, dragees or capsules in containers that do not have a stopper with shock absorbers.

It is allowed to use medical absorbent cotton wool or carding viscose tape.

The main types of secondary packaging used for medicines:

Cardboard is used to produce packs for jars, test tubes, vials of injection medications, bottles, aerosol cans, ampoules; boxes are used for packaging ampoules, vials, syringe tubes;

Polymers are used to make contour packaging for ampoules, bottles of injection medications, and syringe tubes.

When packaging ampoules, it is allowed to use medical alignin as a shock absorber. Each package of ampoules must include a device for opening ampoules.

According to their purpose, packaging is divided into: consumer, group and transport.

Consumer packaging with medicinal products must be packaged in group containers - cardboard boxes or stacks, followed by packing the stack in wrapping paper. Glass jars, test tubes, vials, bottles, aerosol cans, aluminum tubes can be packed in shrink film. If the medicinal product does not have secondary packaging, then instructions for use (or inserts) in a quantity equal to the number of primary packaging must be included in the group packaging. Container sizes must be selected in accordance with the number of individual packages (no more than 200 pieces in a group container).

Group containers with medicines must be glued or tied. The requirements for gluing are specified in the regulatory and technical documentation for specific types of medicines. For gluing group containers, it is allowed to use tape with a sticky layer, gummed adhesive tape, coated paper, wrapping paper, and sack paper. Each packaging unit of any type of group container is supplied with a label. For tying group containers, materials are used to ensure the strength of the packaging. When gluing or tying group containers, the ends are sealed with a tamper evident label.

Group and transport packaging is used for transportation, warehousing, storage of goods and wholesale or small wholesale sales. It provides protection of goods from mechanical influences that may occur as a result of squeezing, bending, twisting, pulling, etc., and losses during transportation and storage.

Transport packaging of medicines includes wooden, polymer and cardboard boxes. Inner surface board boxes or boxes made of sheet wood materials are lined with wrapping paper, parchment, wrapping paper or plastic film. When packaging a medicinal product, the free space in the boxes is filled with soft packaging material, which prevents their movement.

Primary packaging, depending on the materials used, their mechanical stability and strength, which determine the degree of preservation of goods, is divided into groups and types. For various dosage forms, GOST defines the types of primary packaging and closure material.

There are the following types of primary packaging for medicines (according to GOST 17768-90).

Rigid packaging:

    metal is used for primary packaging: jars, test tubes (for packaging tablets, dragees, powders, granules, capsules), aerosol cans, tubes (for ointments, pastes, liniments);

    glass is used for the production of jars, test tubes, vials, bottles (tablets, dragees, powders, granules, capsules, ointments, pastes, liniments, eye drops are packaged in them), ampoules;

    The polymer is used to make test tubes, cups, jars (they are used for packaging tablets, dragees).

Semi-rigid packaging:

    cardboard is used for the production of boxes, packs (for plasters, herbal medicines);

    polymers are used for the production of syringe tubes (for dosage forms intended for injection); dropper tubes are used for packaging eye drops; contours used for packaging suppositories;

    The combined material is used for contour packaging of suppositories, tablets, dragees, capsules, powders, granules, and herbal medicines.

Soft packaging:

    made of polymer is used as packaging in the form of bags for powders, granules, patches;

    paper packaging in the form of a bag, wrapping is used for packaging dragees, tablets, herbal medicines.

All types of primary containers and closures for them must be selected depending on the properties, purpose and quantity of medicines, in accordance with the requirements of state standards and pharmacopoeial monographs.

Materials used for the manufacture of primary containers and closures must be approved for use by the Ministry of Health of the Russian Federation.

The packaging must be the same for each series of packaged medicines and take into account their physical and chemical properties:

    medicines sensitive to light are packaged in light-proof containers;

    medicines containing volatile, weathering, hygroscopic or oxidizing substances are packaged in jars or bottles sealed with screw caps complete with stoppers or gaskets with sealing elements; plugs with sealing elements; roll-up metal caps complete with plugs or gaskets with sealing elements, roll-up metal caps;

    medicines containing highly volatile, weathering, hygroscopic and oxidizing substances intended for export are packaged in containers sealed with roll-up lids or in other containers that ensure their safety;

    each medicinal product containing a volatile substance or having an odor is packaged separately from the others;

    tableted medicines containing essential oils are wrapped in paraffin paper before packaging in test tubes;

    shock absorber seals when packing tablets, dragees or capsules in containers that do not have a stopper with shock absorbers.

It is allowed to use medical absorbent cotton wool or carding viscose tape.

Secondary packaging is designed to protect the inner container and promote sales.

The main types of secondary packaging used for medicines:

    Cardboard is used to produce packs for jars, test tubes, vials of injection medications, bottles, aerosol cans, ampoules; boxes are used for packaging ampoules, vials, syringe tubes;

    Polymers are used to make contour packaging for ampoules, bottles of injection medications, and syringe tubes.

When packaging ampoules, it is allowed to use medical alignin as a shock absorber. Each package of ampoules must include a device for opening ampoules.

Consumer packaging with medicinal products must be packaged in group containers - cardboard boxes or stacks, followed by packing the stack in wrapping paper. Glass jars, test tubes, vials, bottles, aerosol cans, aluminum tubes can be packed in shrink film. If the medicinal product does not have secondary packaging, then instructions for use (or inserts) in a quantity equal to the number of primary packaging must be included in the group packaging.

Container sizes must be selected in accordance with the number of individual packages (no more than 200 pieces in a group container).

Group containers with medicines must be glued or tied. The requirements for gluing are specified in the regulatory and technical documentation for specific types of medicines.

For gluing group containers, it is allowed to use tape with a sticky layer, gummed adhesive tape, coated paper, wrapping paper, and sack paper.

Each packaging unit of any type of group container is supplied with a label.

For tying group containers, materials are used to ensure the strength of the packaging. When gluing or tying group containers, the ends are sealed with a tamper evident label.

Group and transport packaging is used for transportation, warehousing, storage of goods and wholesale or small wholesale sales. It provides protection of goods from mechanical influences that may occur as a result of squeezing, bending, twisting, pulling, etc., and losses during transportation and storage.

Transport packaging of medicines includes wooden, polymer and cardboard boxes. The inner surface of plank boxes or boxes made of sheet wood materials is lined with wrapping paper, parchment, wrapping paper or plastic film. When packaging a medicinal product, the free space in the boxes is filled with soft packaging material, which prevents their movement. Packaging alignin can be used as a sealing material; paper and cardboard waste; shavings made of porous elastic polymer materials. The gross weight of the package should not exceed 20 kg.


Medicine packaging technology In pharmaceutical production, containers and packaging play a special role, providing not only the possibility of convenient use of medicines, but also the preservation of their properties during storage. The problem of packaging finished medicines requires constant attention, because... its irrational choice leads to a decrease in quality and significant losses of medicines and packaging materials.


Basic concepts about containers and packaging Packaging is a set of means designed to protect the drug from environmental influences, damage and loss and to facilitate the handling process. The container is an element of packaging and is a container designed to contain products. Packaging combines containers, medicine, closures and auxiliary elements that determine the consumer properties of the product. For example, an empty bottle is a container, and a bottle with a medicinal product, a stopper or dropper, a label or other auxiliary materials is a packaging. In the production of medicinal products, packaging is classified into the following types: Primary packaging - individual or consumer packaging, the material of which is in direct contact with the drug. It is intended to create the necessary conditions to ensure long-term preservation of the drug contained in it. Secondary packaging is packaging that is designed to protect the integrity of primary packaging and to provide more complete information (for example, about methods of use and doses of drugs).


Secondary packaging provides the simplest and most convenient accounting and control of products. Cardboard packs and boxes are used as secondary packaging, where tablets, dragees, capsules, bottles and ampoules with liquid and powdered drugs, metal and polymer tubes with tablets, tubes with ointments, bags with powdered drugs are placed in primary contour-cellular packaging. In some cases, secondary packaging creates additional sealing and protection of primary packaging from influence external factors. Secondary packaging also belongs to consumer packaging, so it is important to ensure the necessary consumer properties of the packaging, such as: ease of wearing, content of information about storage and administration of the product, control of the first opening of the package, preservation of microbiological purity and attractiveness. appearance. Group packaging (or block packaging) is a group of primary or secondary packaging, which is formed when packaging products in shrink film, paper, or cardboard boxes. Transport packaging packaging in transport containers in which products are delivered to places of distribution and sale. It can be the same for each series of drugs.


Materials and methods for manufacturing packaging Container materials approved for use in the pharmaceutical industry are subject to special requirements: gas and vapor impermeability, chemical indifference to drugs, resistance to temperature influences, strength, light tightness, barrier resistance to microorganisms, ensuring maximum term suitability. There are the following types of primary packaging for medicines (according to GOST): Rigid packaging 1. metal is used for primary packaging: jars, test tubes (for packaging tablets, dragees, powders, granules, capsules), aerosol cans, tubes (for ointments, pastes, liniments ); 2. glass is used for the production of jars, test tubes, vials, bottles (tablets, dragees, powders, granules, capsules, ointments, pastes, liniments, eye drops are packaged in them), ampoules; 3. polymer is used for the manufacture of test tubes, cups, jars (they are used for packaging tablets, dragees).


Semi-rigid packaging: 1. cardboard is used for the production of boxes, packs (for plasters, herbal medicines); 2. polymers are used for the production of syringe tubes (for dosage forms intended for injection); dropper tubes are used for packaging eye drops; contours used for packaging suppositories; 3. The combined material is used for contour packaging of suppositories, tablets, dragees, capsules, powders, granules, herbal medicines. Soft packaging: 1. made of polymer, used as packaging in the form of bags for powders, granules, patches; 2. paper packaging in the form of a bag, wrapper is used for packaging dragees, tablets, herbal medicines. All types of primary containers and closures for them must be selected depending on the properties, purpose and quantity of medicines, in accordance with the requirements of state standards and pharmacopoeial monographs. Materials used for the manufacture of primary containers and closures must be approved for use by the Ministry of Health of the Russian Federation.


The packaging must be the same for each series of packaged medicines and take into account their physical and chemical properties: 1. medicines sensitive to light are packaged in light-proof containers; 2. medicines containing volatile, weathering, hygroscopic or oxidizing substances are packaged in jars or bottles sealed with screw caps complete with stoppers or gaskets with sealing elements; plugs with sealing elements; roll-up metal caps complete with plugs or gaskets with sealing elements, roll-up metal caps; 3. medicines containing highly volatile, weathering, hygroscopic and oxidizing substances intended for export are packaged in containers sealed with roll-on lids or in other containers that ensure their safety; 4. each medicinal product containing a volatile substance or having an odor is packaged separately from the others; 5. tableted medicines containing essential oils are wrapped in paraffin paper before packaging in test tubes; 6. shock absorber seals when packing tablets, dragees or capsules in containers that do not have a stopper with shock absorbers. It is allowed to use medical absorbent cotton wool or carding viscose tape. Secondary packaging is designed to protect the inner container and promote sales.


The main types of secondary packaging used for medicines: 1. cardboard is used to produce packs for jars, test tubes, vials of injectable medicines, bottles, aerosol cans, ampoules; boxes are used for packaging ampoules, vials, syringe tubes; 2. Polymers are used to make contour packaging for ampoules, bottles of injection medications, and syringe tubes. When packaging ampoules, it is allowed to use medical lignin as a shock absorber. Each package of ampoules must include a device for opening ampoules. Consumer packaging with medicinal products must be packaged in group containers: cardboard boxes or stacks, followed by packing the stack in wrapping paper. Glass jars, test tubes, vials, bottles, aerosol cans, aluminum tubes can be packed in shrink film. If the medicinal product does not have secondary packaging, then instructions for use (or inserts) in a quantity equal to the number of primary packaging must be included in the group packaging. Container sizes must be selected in accordance with the number of individual packages (no more than 200 pieces in a group container). Group containers with medicines must be glued or tied. The requirements for gluing are specified in the regulatory and technical documentation for specific types of medicines. For gluing group containers, it is allowed to use tape with a sticky layer, gummed adhesive tape, coated paper, wrapping paper, and sack paper. Each packaging unit of any type of group container is supplied with a label. For tying group containers, materials are used to ensure the strength of the packaging. When gluing or tying group containers, the ends are sealed with a tamper evident label.


Group and transport packaging is used for transportation, warehousing, storage of goods and wholesale or small wholesale sales. It provides protection of goods from mechanical influences that may occur as a result of squeezing, bending, twisting, pulling, etc., and losses during transportation and storage. Transport packaging of medicines includes wooden, polymer and cardboard boxes. The inner surface of plank boxes or boxes made of sheet wood materials is lined with wrapping paper, parchment, wrapping paper or plastic film. When packaging a medicinal product, the free space in the boxes is filled with soft packaging material, which prevents their movement. Packaging alignin can be used as a sealing material; paper and cardboard waste; shavings made of porous elastic polymer materials. The gross weight of the package should not exceed 20 kg.

In merchandising there are different classifications packaging. For medical and pharmaceutical products, packaging can be classified according to the following signs:

1) for its intended purpose;

2) by composition;

3) by application.

Classification of packaging by purpose

Based on their purpose, packaging is divided into consumer, transport, industrial and preservative.

Consumer packaging goes with the product directly to the consumer, is an integral part of the product and is included in its price. Such packaging, as a rule, is not intended for independent transportation; it has limited weight, capacity and dimensions.

Transport packaging constitutes a separate independent transport unit and is used for transporting goods in consumer packaging or unpackaged products.

Industrial packaging is used as part of the technology in the organization production process at one or more enterprises and is not intended for sale of products in retail trading network.

Preservative packaging is necessary for the long-term preservation of raw materials, materials, products, equipment, as well as hazardous waste (chemical, radioactive, etc.).

Based on their composition, there are two types of packaging: containers and auxiliary packaging materials.

Classification of packaging by composition

The container is the most important, and sometimes the only element of packaging, which is a product for placing products, made in the form of a closed or open case. The container performs packaging functions independently or in combination with auxiliary packaging means, which are other elements of packaging.

Auxiliary packaging materials that are used in consumer and transport packaging include: closures, labels, coatings, wrappers, sealing, fastening and shock-absorbing elements, substances that create a protective atmosphere inside the package.

Based on application, packaging is divided into primary, secondary and tertiary.


Classification of packaging by application

Primary (individual) packaging is intended to create necessary conditions, ensuring long-term safety of the products contained in it.

Primary packaging includes: glass bottles and jars with a screw neck, dart bottles and jars, glass jars with a triangular rim, bottles for blood and blood substitutes, polymer containers, capsules, aluminum tubes, disposable syringe tubes, aerosol cans with protective polyethylene or polymer coating based on polyvinyl chloride, bags made of polymer materials or paper, test tubes made of dart, metal or plastic, contour packaging, wrapping a briquette (medicinal plant raw materials) in a parcel label.

The primary packaging material in contact with the medicinal product has special requirements:

Gas and vapor tightness;

Chemical indifference to drugs;

Strength;

Resistance to temperature influences;

Lightproof;

Barrier resistance to microorganisms.

In addition to these requirements, great attention is paid to the presence of the necessary consumer properties of the packaging:

Transportability of the packaging (when worn, transported);

Availability of information on the storage and administration of drugs;

Pleasant appearance;

Appropriate sizes ensuring ease of use and completeness;

Ease of destruction of used packaging or the possibility of reusing packaging both for its intended purpose and for other purposes.

Special requirements should be mentioned, such as:

Control of the first opening of the package;

Special placement of drugs with the possibility of repeated use without violating the tightness and sterility;

Control over the use of drugs.

The choice of one or another type of packaging is primarily dictated by the properties of the medicinal product, which determine the nature of the packaging materials used, the type and design features of the packaging, based on maximum satisfaction of consumer requirements and compliance with the interests of production.

Secondary (group) packaging combines a certain number of primary packaging and is intended to ensure their safety.

The main functions of secondary packaging are:

1) safety of the primary packaging from atmospheric influences;

2) the possibility of the simplest, most convenient accounting and control of products;

3) meeting the needs of consumers for information about drugs.

Types of secondary packaging: cardboard box with instructions and a sticker label, packaging made of polymer film and foil, glass jar, bags or bags made of kraft paper, film bags made of polymer materials, paper wrapper with a parcel post and label (for sanitary and hygiene items).

Tertiary or transport packaging is designed to deliver products to distribution and sales points. As a rule, it does not reach the consumer.

According to existing requirements, transport packaging must protect drugs from exposure to precipitation and dust, solar radiation, mechanical damage.

Types of transport packaging: corrugated cardboard boxes, wooden boxes, containers, bags made of polymer materials, kraft paper bags, fabric bags.

In practice there may be various options, when multiple secondary packaging is used or there is no transport packaging, but in most cases the specified classification is quite acceptable.

General requirements to the packaging are presented on

The safety of packaging lies in the absence of mechanical or chemical contamination of the product by packaging components, including substances harmful to the human body.

Environmental friendliness is the ability of packaging to not cause significant harm during its disposal and use. environment.

Reliability of packaging is the ability to preserve the product or its tightness for a long time.

Compatibility is the ability of packaging not to change the consumer properties of packaged goods.

Interchangeability - the ability of one type of packaging to replace another type of packaging when used for the same purpose functional purpose.

The aesthetic properties of the packaging are the use of modern design and attractive materials for its manufacture.

Economic efficiency is determined by the cost of packaging, the cost of operation and the cost of disposal.


Basic packaging requirements

INTRODUCTION........................................................ ........................................................ .3

CHAPTER 1. MODERN APPROACHES TO DRUG PACKAGING...................................5

1.1 Types and functions of drug packaging............................................................ .............................5

1.2 Basic requirements for drug packaging.................................................... ................10

CHAPTER 2. ANALYSIS OF CONSUMER PREFERENCES....................................14

2.1 The influence of packaging on consumer preferences....................................14

2.1 Determination of consumer preferences in relation to medicines and their packaging.................................................... ....................17

CONCLUSION................................................. ........................................................ ..23

BIBLIOGRAPHY................................................ ....................................25

APPLICATIONS........................................................ ........................................................ ..27

INTRODUCTION

Relevance of the topic. With the development of a market economy, the performance of domestic enterprises largely depends on whether their products are successful in the market. Therefore, there is increasingly a need to study the state of consumer preferences in relation to a particular product. When purchasing or using goods, including medicines, to meet their needs, consumers have the right to the safety and proper quality of goods, to state protection of their rights and compensation for losses caused by goods of inadequate quality. Awareness of this information poses the task for pharmaceutical companies to conduct more in-depth scientific research in this direction.

The production of pharmaceutical packaging is an integral component of the pharmaceutical industry. Packaging has become a very important part of drug production because... Innovation in the development of new drugs and new drug delivery systems has reached a very high level. Pharmaceutical packaging must meet the increasing requirements for medicines.

Due to the unique requirements for pharmaceutical products, drug packaging must ensure that the quality of drugs is maintained during transportation, which will increase their shelf life.

Goal of the work– study the features of modern medicine packaging.

To achieve the goal, it is necessary to solve the following tasks:

1. Study the types and functions of drug packaging;

2. Consider the basic requirements for drug packaging;

3. Conduct an analysis and find out the influence of packaging on consumer preferences.

Object of study. Packaging and decoration medicines.

Subject of study. Requirements for the quality of packaging of medicinal products.

Research hypothesis. The material and appearance of pharmaceutical packaging influence consumer preferences.

Work structure. Course work consists of an introduction, two chapters, a conclusion, a list of references and an appendix.

CHAPTER 1. MODERN APPROACHES TO DRUG PACKAGING

Types and functions of drug packaging

Packaging is understood as a complex consisting of containers, auxiliaries, and packaging materials that determine the consumer and technological properties of the packaged product.

There are two types of packaging for medicines: primary packaging (individual) and secondary packaging (group or consumer).

Primary packaging– direct (individual) packaging that helps preserve the product during its sale; is part of the goods and, in general, cannot be transported independently;

Secondary packaging– serves to protect individual packaging and surpasses it in information content; performs a protective function in relation to the product and primary packaging and creates conditions for their immunity to external influences.

Primary packaging, depending on the materials used, their mechanical stability and strength, which determine the degree of preservation of goods, is divided into groups and types. For various dosage forms, GOST defines the types of primary packaging and closure material.

There are the following types of primary packaging for medicines (according to GOST 17768-90) (Appendix 1).

By material: hard, semi-hard, soft.

Rigid packaging:

Metal is used for primary packaging: jars, test tubes (for packaging tablets, dragees, powders, granules, capsules), aerosol cans, tubes (for ointments, pastes, liniments);

Glass is used for the production of jars, test tubes, vials, bottles (tablets, dragees, powders, granules, capsules, ointments, pastes, liniments, eye drops are packaged in them), ampoules;

The polymer is used for the manufacture of test tubes, cups, jars (they are used for packaging tablets, dragees).

Semi-rigid packaging:

Cardboard is used for the production of boxes, packs (for plasters, herbal medicines);

Polymers are used for the production of syringe tubes (for dosage forms intended for injection); dropper tubes are used for packaging eye drops; contours used for packaging suppositories;

The combined material is used for contour packaging of suppositories, tablets, dragees, capsules, powders, granules, and herbal medicines.

Soft packaging:

Made from polymer, it is used as packaging in the form of bags for powders, granules, patches;

Paper packaging in the form of a bag or wrap is used for packaging dragees, tablets, and herbal medicines.

All types of primary containers and closures for them must be selected depending on the properties, purpose and quantity of medicines, in accordance with the requirements of state standards and pharmacopoeial monographs.

Materials used for the manufacture of primary containers and closures must be approved for use by the Ministry of Health of the Russian Federation.

Main types secondary packaging used for medicines:

Cardboard is used to produce packs for jars, test tubes, vials of injection medications, bottles, aerosol cans, ampoules; boxes are used for packaging ampoules, vials, syringe tubes;

Polymers are used to make contour packaging for ampoules, bottles of injection medications, and syringe tubes.

When packaging ampoules, it is allowed to use medical alignin as a shock absorber. Each package of ampoules must include a device for opening ampoules.

By purpose packaging is divided into: consumer, group and transport.

Consumer packaging with medicines should be packaged in group containers - cardboard boxes or stacks, followed by packing the stack in wrapping paper. Glass jars, test tubes, vials, bottles, aerosol cans, aluminum tubes can be packed in shrink film. If the medicinal product does not have secondary packaging, then instructions for use (or inserts) in a quantity equal to the number of primary packaging must be included in the group packaging. Container sizes must be selected in accordance with the number of individual packages (no more than 200 pieces in a group container).

Group packaging with medicines should be glued or tied. The requirements for gluing are specified in the regulatory and technical documentation for specific types of medicines. For gluing group containers, it is allowed to use tape with a sticky layer, gummed adhesive tape, coated paper, wrapping paper, and sack paper. Each packaging unit of any type of group container is supplied with a label. For tying group containers, materials are used to ensure the strength of the packaging. When gluing or tying group containers, the ends are sealed with a tamper evident label.

Group and transport packaging is used for transportation, warehousing, storage of goods and wholesale or small wholesale sales. It provides protection of goods from mechanical influences that may occur as a result of squeezing, bending, twisting, pulling, etc., and losses during transportation and storage.

TO transport packaging medicines include wooden, polymer and cardboard boxes. The inner surface of plank boxes or boxes made of sheet wood materials is lined with wrapping paper, parchment, wrapping paper or plastic film. When packaging a medicinal product, the free space in the boxes is filled with soft packaging material, which prevents their movement. Packaging alignin can be used as a sealing material; paper and cardboard waste; shavings made of porous elastic polymer materials. The gross weight of the package should not exceed 20 kg.

Liquid and viscous medicines require the use of packaging that ensures accurate dosage. Mainly used glass containers, for example: jars and bottles made of glass with a screw neck, oval jars and bottles with a ground stopper, jars and bottles made of dart, etc.

Medical ointments Currently they are produced mainly in aluminum tubes and glass containers (they use low glass jars with a screw neck, dart jars). Aluminum tubes are made in two versions: regular and with an extended spout. The inner surface of the tubes is covered with a protective layer of varnish, and the outer surface is covered with decorative resistant enamel, on which markings are applied. The series number is embossed on the tail of the tube when it is sealed.

Solid dosage forms . Tablets account for approximately 70% of the total production of finished medicines, and their production tends to increase. Tablets are packaged in a variety of containers, including paper (currency), glass (jars and bottles), metal (test tubes, pencil cases), etc. The most promising is blister packaging (blisters).

Dosage packs powders are equipped with devices for dispensing of different designs. They are mainly produced by foreign companies and are a two-chamber system consisting of an external closed chamber communicating with the cavity of the container in which the drug is placed, and an internal dosing chamber.

Injection solutions Most often they are packaged in ampoules, which are disposable packages, i.e. disposable packaging.

The glass ampoule is an ideal packaging in terms of its compatibility with pharmaceutical products, tightness and cost. However, at the same time, the fragility of glass is a serious drawback, so expensive secondary packaging is needed to prevent breakage, depressurization of ampoules, and the formation of cracks. IN last years Ampoules made from polymer materials are used, but here problems arise related to the compatibility of plastics with the drug solution and the shelf life of these ampoules.

Some special types of packaging. For unstable drugs that lose activity in solutions or require preparation immediately before use, packaging is developed for separate storage of components. These are combined packages having two separate chambers with medicinal substances, ready to be mixed at the time of consumption (expensive but necessary packaging).