Requirements for labeling and packaging of medicines. Pharmaceutical packaging. Primary, secondary, transport packaging of medicines - presentation Consumer packaging of medicines

Packaging plays an important role in the production and distribution of medicines. It must fully comply with all regulatory requirements for this type of product. Pharmaceutical packaging falls into three main categories:

Primary packaging

Primary is in direct contact with the medicinal product and is designed to create conditions that will ensure long-term preservation of products. It includes: glass ampoules, vials, jars and bottles, polymer containers, aerosol cans, blisters, capsules, aluminum tubes, syringes and more.

secondary packaging

It does not come into direct contact with the drug and is designed to protect and preserve the primary packaging, as well as to account for and control stored products. There are certain requirements for packaging for medicines:

  • legibility of information printed on it;
  • brief instructions for use;
  • safe handling;
  • control of the first opening (if possible);
  • lack of aids for opening.

For the manufacture of secondary packaging, various materials are used:

  • Cardboard. Packs and boxes are made from it, in which blisters with tablets, capsules, aerosol cans, vials, bottles, polymer containers and so on are packed.
  • Polymers. They are used for the manufacture of contour packaging for ampoules, vials, syringe tubes. In most cases, the medicine is already in polymer packaging, everything is packed in cardboard.
  • Shrink. It packs jars, vials, bottles. Often in this form, drugs are transported.

Another important function secondary packaging performs is to provide useful information about the contents of the box. On the pharmaceutical packaging indicate the name, concentration of the active substance, the number of tablets or capsules, the warranty (limit) period of use. This information is placed on at least two opposite sides of the box. It is also very important to note that if the primary packaging needs to be opened using any means, then they must be included in the medicine box.

Tertiary packaging

Tertiary or transport packaging is designed to deliver products to the point of sale. The main task of transport packaging is to protect medicines from external physical influences and mechanical damage. As a tertiary container, wooden boxes, containers, as well as bags can be used: fabric, paper and polymer materials. Very often, for long-distance transportation, boxes and boxes are placed on pallets, wrapped with stretch film or glued with adhesive tape, which allows both to optimize the loading process and additionally protect medicines from mechanical influences.

Requirements for transport packaging:

  • safety - is the absence of contamination of products with packaging components, including those harmful to humans;
  • reliability - the safety of drugs in the proper form for a long time;
  • environmental friendliness - the possibility of recycling after use;
  • interchangeability - the possibility of replacement, while not changing the functional purpose;
  • The aesthetic appeal of the packaging also plays an important role.

If you need quality pharmaceutical packaging, then you should take this very seriously, because not every company can fulfill the high requirements that apply to such products.

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Medicinal products and prepared medicinal products, in

depending on their state of aggregation and properties, they are stored and dispensed from pharmacies in

corresponding container.

Packaging is used to protect medicines from the action of external

factors: light, temperature, air and moisture. It should also be kept in mind that the properties

the packaging used depends on the duration of storage and the quality of medicines,

because the material from which it is made can interact with

medicines.

Containers and closures must meet the requirements for cleanliness indicators,

protective properties, environmental resistance, appearance and adhesion

The indicators of the protective properties of the material include vapor permeability

water, volatile substances, gases (atmospheric and released by medicinal products),

water, alcohol, oils, fats, organic substances and others, as well as sorption by the material

those ingredients of medicinal products that have the ability to penetrate

through the material.

Indicators of environmental sustainability of materials include

resistance to atmospheric factors (light, temperature, relative humidity

air), mechanical influences (punctures, compression, shock, vibration),

drugs, mold, microorganisms; no chemical

adsorption and diffuse interaction with the packaged drug.

Appearance indicators include color and color uniformity, smoothness

surface and its cleanliness (absence of grease and mechanical contamination, corrosion, etc.);

Depending on the purpose, there are prescription containers, stationary and

material.

Prescription containers are intended for dispensing medicines to patients.

Usually small in size and easy to use. Liquids are released into

bottles without ground stoppers with a capacity of 5.0 to 500.0 g, injection solutions

In neutral glass bottles, sealed with rubber stoppers and

metal caps for running in.

Distinguish between nominal and actual capacity of glassware: actual

capacity is usually 15-20% higher than nominal. Rated capacity is

volume equal to the volume of liquid dispensed in the vial. The level placed in the vial

liquid should not be higher than the shoulders of the vial. The dispensed liquid is in no way

case should not fill the neck of the vial.

Medicinal preparations of a thick and ointment-like consistency are released in

jars made of glass, porcelain, plastic and other materials,

with a capacity of 5.0 to 500.0 g.

Bulk drugs are released in paper (from writing paper,

parchment, waxed or waxed), gelatinous or starchy

capsules that are placed in paper bags or boxes. Hygroscopic dry

substances (not divided into doses) are released in bottles or test tubes with stoppers.

The container is stationary - the so-called "shtanglas", designed for storage

loose, liquid, thick and ointment-like medicines in the assistant's room.

It is made of glass and porcelain with ground stoppers from 0.5 to 2 liters.

For storage of viscous liquids (castor oil, syrups, ichthyol, etc.)

use special "collar" rods, in which near the outer

the surface of the neck has a side, on the inner surface of which a recess is made for

runoff of a viscous liquid. In addition, in order to preserve substances that emit corrosive vapors

(mustard oil, concentrated ammonia, etc.)

cork and lapped cap.

Stanglas are not the main storage for medicines. They

are systematically replenished from large material cans or bottles.

The material container is intended for transportation and storage of stocks of medicines.

funds in the basements and material rooms of pharmacies. This is a pretty solid container.

of considerable size, in which the bulk of medicines are stored.

Depending on their state of aggregation, a container made of

relevant materials. For example, liquids are stored in bottles with a capacity of

from 3 to 30 kg; bulk solids - in cans with a capacity of up to 20 kg, in paper and

fabric bags - with a capacity of up to 50 kg, in cans, wooden boxes and barrels -

up to 300 kg; substances of a thick consistency are stored in porcelain and glass jars - up to

20 kg, as well as in metal and wooden containers.

Pharmaceutical containers are made from various materials. The main ones

are: glass, polymers, porcelain, metals, cardboard and paper. Basic materials for

closures: peel, rubber, polymers, paper, glass.

Finished medicinal products placed in the appropriate pharmacy

dishes, depending on their state of aggregation and properties, are corked using

stoppers (cork, rubber, plastic, polyethylene, glass) and lids

(plastic, metal).

Pharmaceutical glassware during transportation is contaminated with dust and packaging

materials (straw, shavings, etc.), which can contain a wide variety of

pathogenic microbes - tetanus spores, gas gangrene bacteria, etc. Therefore,

all utensils should be carefully cleaned, degreased, washed and disinfected. Washing

dishes are carried out in the washing room, in which they must be allocated and

sinks for washing dishes intended for injectables are marked

solutions and eye drops, internal and external dosage forms. In these

dishes are washed in sinks (cylinders, measuring cylinders, funnels, mortars, etc.),

used in the preparation of dosage forms. It is forbidden to use these

sinks for washing hands.

Processing of glass containers. Exempt from packaging material

glassware is rinsed inside and out with tap water to remove

mechanical impurities and residues of medicinal substances, then in a special tank

soak in a solution of detergents, heated to 50-60 C for 20-25 minutes.

Heavily soiled dishes are soaked for a longer time (2-3

hours). Dishes containing fat residues are preliminarily degreased with 3-5%

green soap solution or 0.5-2% detergent solution.

As detergents for manual dishwashing, it is allowed to use

warm water suspension of mustard (1:20) and sodium bicarbonate solution 0.5% with

soap shavings (household soap without fragrance GOST 790-89).

For automatic and manual washing of pharmacy glassware, it is allowed to use

detergents: "Lotus", "Astra", "Lotus-automatic, etc. in the form of 0.5% solutions;

SMS - synthetic detergent, powder (GOST 25644-88) - 1% -

ny solution and others

After soaking in a detergent solution, the dishes are washed in the same solution.

with a brush or washing machine. For complete rinsing of detergents,

tap water and 3 times purified water, filling vials and bottles completely. At

automatic rinsing, depending on the type of washer, holding time in

rinse cycle for 5 to 10 minutes.

After treatment with detergent solutions of mustard or sodium bicarbonate with

With soap, washing five times with water (2 times with tap water and 3 times with purified water) is enough.

Glass containers intended for packaging eye drops, eye ointments,

ointments used to treat wounds and mucous membranes, after treatment, as indicated

was higher, must be sterilized with hot air in dry heat

sterilizers (drying cabinets) at a temperature of 180 ° C - 60 minutes.

Before washing, glass pharmacy dishes (from infectious diseases departments

hospitals) are compulsorily disinfected using appropriate

solutions: a solution of activated chloramine 1%; freshly prepared

3% hydrogen peroxide solution containing 0.5% detergents, etc.

Processing of plastic containers. Plastic packaging is also subject to sanitary

hygienic treatment. Plastic canisters, jars, bottles, cups are washed in

for 2-3 minutes in a 0.5% household or bath solution heated to 60 ± 5 C

soap, 0.5% solution of detergent "Lotus" or "Astra" or in solution

mustard. Washed products are rinsed 4-5 times with tap water to remove

detergents, then soak for 20 minutes in tap water heated

to a temperature of 60 ± 5 C or for 2-3 hours in tap water at room temperature

temperature, after which the products are rinsed 2-3 times with purified or desalted

Products made of heat-resistant plastics (polypropylene, high density polyethylene)

density, a mixture of polyethylenes), it is allowed to disinfect by boiling in water or

treatment with flowing steam for 1 hour.

Jam processing. The procedure for processing rubber stoppers. New rubber

corks are processed in this way. They are washed by hand or in a washing machine in

hot 55 ± 5 C 0.5% solution of detergents "Lotos", "Astra" or others on

for 3 minutes (the ratio of the mass of plugs and the mass of the detergent solution

1:5); washed 5 times with hot tap water, each time replacing it with fresh, and 1

once purified water; boil in 1% sodium bicarbonate solution for

30 minutes, washed 1 time with tap water and 2 times with purified water. Then they are placed in

glass or enameled containers, pour purified water, close and

kept in a steam sterilizer at a temperature of 120 ± 2 ° C for 60 minutes,

the water is then drained and the plugs are washed again with purified water.

After processing, the corks are sterilized in bixes in a steam sterilizer at

temperature 120±2 °C for 45 minutes. Sterile stoppers are kept closed.

biksakh no more than 3 days. After opening the bixes, the corks should be used in

within 24 hours.

When stockpiling rubber stoppers after processing as above, do not

subjected to sterilization, dried in an air sterilizer at a temperature not exceeding 50 C

within 2 hours and stored for no more than 1 year in closed boxes or jars in the dark

cool place. Sterilize rubber stoppers before use as directed.

Aluminum caps that are used with rubber stoppers when

capping of vials and bottles, are processed in this way: they are kept for 15 minutes in

1 or 2% detergent solution, heated to a temperature of 75 ± 5 ° C, then

the solution is drained and the caps are washed with running tap water. Pure

the caps are dried in an air sterilizer in biks at a temperature of 55 ± 5 °C. Stored in

closed containers (bixes, cans, boxes) in conditions that exclude their contamination.

The procedure for processing polyethylene corks. New polyethylene stoppers

washed several times with hot (55 ± 5 C) tap water, rinsed with water

cleaned and sterilized by immersion in fresh 6% peroxide solution

hydrogen for 6 hours, then washed with purified water and dried in an oven

at a temperature of 55 ± 5 C. Dried corks are stored in sterile jars with ground

stoppers, biksah for three days in conditions that exclude their contamination.

Processing procedure for plastic screw caps. New plastic

the corks are washed several times with hot (55 ± 5 C) tap water and dried in

drying cabinet at a temperature of 55 ± 5 C. Dried corks are stored in closed

boxes, boxes, etc. under conditions that exclude their contamination.

Samvel Grigoriano on whether it is expedient to allow the "sharing" of packages of medicines

In the work of the first-timer, there are often situations when he would like to fulfill the request of the buyer, but he does not have the right. What can you do, pharmaceutical legislation, like other branches of law, is full of restrictions and prohibitions. Most of them are justified and do not raise doubts, disputes about their usefulness and necessity.

But there are also such legal norms that are assessed as ambiguous not only by practitioners and experts in the pharmaceutical industry, but sometimes by representatives of regulators. A fresh example: in March of this year, it became known that the Ministry of Health of the Russian Federation is considering the possibility of allowing pharmacy organizations to sell drugs not only in secondary packaging, if this is required by the course of treatment prescribed by the doctor (Rossiyskaya Gazeta, Federal issue No. 6621/50). Secondary packaging, as you know, is also called consumer, or external (as opposed to primary, internal).

In exceptional cases - when it is possible to share secondary medical packaging

This topic is regulated by the order of the Ministry of Health and Social Development No. 785 of December 14, 2005 (“On the procedure for dispensing medicines”). Paragraph 2.8 of this regulatory legal act establishes that violation of secondary packaging is allowed only "in exceptional cases, if the pharmacy institution (organization) is unable to fulfill the appointment of a doctor (paramedic)".

The wording, it must be said, is very vague. It can be assumed that the cited fragment refers to a discrepancy between the course of treatment prescribed by a specialist and the number of tablets / capsules / ampoules, etc. (in a word, with “numero”) in the secondary packaging. But it is impossible to build work on assumptions, especially in the field of healthcare; each legal norm must be clear and unambiguous.

The same applies to the phrase "in exceptional cases". Here, health care and drug provision practitioners - in particular, pharmacists- and first-time pharmacists - are also required by legislation to provide clear, unambiguous explanations as to the circumstances under which such cases may occur. For example, if they occur every time the course of treatment prescribed to the patient does not coincide with the “numero” of the secondary package, then such situations in everyday pharmacy practice are not so rare as to be assessed as “exceptional”. Lack of clarity in these matters can literally be costly - judging by media reports, regulatory authorities periodically “fine” pharmacy organizations on the basis of non-compliance with the norms of clause 2.8 of order No. 785.

In addition to the above, this paragraph contains two more provisions. One of them explains that in those very exceptional cases when a violation of the secondary factory packaging is allowed, the medicinal product should be dispensed in a pharmacy package with the obligatory indication of the name, factory batch, expiration date, series and date according to the laboratory packing log and providing the patient with other necessary information, in particular, instructions for the medical use of the drug.

Another provision is more concise; it clearly and unequivocally establishes that the primary packaging of medicinal products is not allowed to be violated during dispensing. It is worth recalling this in connection with the fact that in March of this year headlines like “Pharmacists will be allowed to sell pills by the piece” multiplied in the media. First, the Ministry of Health has not yet decided anything; whether it will decide at all and in what form is still unknown. Secondly, depending on what is meant in this case by “thing”. If the blister is one thing; if one tablet, then this is impossible without the annulment of the provisions of clause 2.8 of order No. 785, since it would be a violation of the primary packaging.

In March, headlines such as "Pharmacists to be allowed to sell pills by the piece" multiplied in the media. First, the Ministry of Health has not yet decided anything; whether it will decide at all and in what form is still unknown. Secondly, depending on what is meant in this case by "thing"

Why now?

This regulation has been in effect for almost ten years now. Why did the Ministry of Health of the Russian Federation decide to consider the advisability of adjusting them right now? Two reasons can be suggested. The first follows from what we said above: the courses of treatment prescribed by doctors are not always a multiple of the number of tablets / capsules / ampoules in the secondary packaging. This discrepancy is by no means exceptional, although it cannot be said that it is very frequent, and requires an optimal solution, primarily in the legal and regulatory sphere. These circumstances were often pointed out by experts, practitioners (pharmacists, pharmacists, doctors); patients complained about them.

It is clear that introducing a rule obliging doctors to prescribe medicines only "by packaging" is a wrong decision. Firstly, the “numero” packages of not all drugs correspond to traditional courses of treatment. Secondly, therapeutic schemes are by no means something once and for all established, frozen - they are prone to change and variability. Pharmaceutical production is not always and not immediately able to fix, take into account these changes and make appropriate adjustments to the packaging process.

Thirdly, in addition to traditional therapeutic schemes, there are special cases. Each body is unique, each patient needs an individual approach. In some and very frequent cases, doctors prescribe to their patients courses of treatment that are somewhat different from the usual, standard ones. Such courses, as a rule, "do not match the packages." And it is clear that the packaging part of pharmaceutical production cannot provide for the whole variety of such individual cases.

The second reason for the current attention of the Ministry of Health to this topic also lies on the surface. The change in the situation in the economy and the industry raises questions about the advisability of maintaining certain restrictions and prohibitions. Initially in demand and necessary, over time they can lose their relevance and even become, to some extent, an obstacle in the provision of medicines to the population and the optimal service of pharmacy visitors.

In 2014–2015 the situation in the Russian economy and the field of drug circulation has become more complicated. The factors that have a significant impact on the state of the domestic pharmaceutical industry are the trend towards higher prices for medicines and a decrease in real incomes of citizens. Under these conditions, in pharmacies, requests from customers to release this or that drug “not entirely”, that is, as part of a consumer (secondary) package, but “partially” - for example, one or two blisters, have become more frequent.

So the current attention of our main regulator to this topic can be explained by the fact that over the past year it has been updated. Probably, the Ministry of Health is thinking about the fact that in matters of dispensing drugs in various packages, more flexibility should be shown, taking into account the current situation and the variability of therapeutic schemes.

No more, no less

While the Ministry of Health is evaluating the feasibility of any changes on this issue, we will also try to consider them. Let us give examples from the daily practice of a pharmacist.

A patient suffering from bronchitis was prescribed antibiotic T. at a dosage of 500 mg, one tablet once a day for seven days. But there are practically no packages of this drug "No. 7" in the Russian pharmacy network, but there are packaged in five and ten. The drug is very expensive - the calculated price of one tablet fluctuates around a hundred rubles. One package "No. 5" is not enough for the patient; if he buys two (or one package of "No. 10"), he will overpay approximately three hundred rubles for three tablets, which he does not currently need and may never need again.

Let's take a "over-the-counter" example. The popular laxative F. is available as a powder for oral solution, in sachets. In production, they are packaged in large cardboard packages of ten, twenty or more pieces. In each such package, there is only one leaflet (instruction for the medical use of the medicinal product). But pharmacy visitors often ask for only two, three or five sachets.

Often, doctors prescribe their patients courses of treatment that differ from the standard ones. Such courses, as a rule, "do not match the packages." And it is clear that the packaging part of pharmaceutical production cannot provide for the whole variety of such individual cases.

It is clear that buyers are trying to reduce what they see as unnecessary spending on medicines so as not to devastate family or personal budgets that are already under strain. And naturally the following question arises. People, on the other hand, acquire medicine not on their own whim, but on medical necessity, in particular, on medical prescription. And if the patient needs not five, not ten, but exactly seven tablets, then why not make sure that he, the patient and the consumer, is given exactly seven - no more, no less?

There is such a Latin term in pharmacy -  quantum satis (translated as “as much as needed”), meaning the required / required amount. It is mainly used in extemporaneous recipes, but in terms of meaning it also fits the situations we are considering.

People acquire medicine not on their own whim, but on medical necessity. And if the patient needs not five, not ten, but exactly seven tablets, then why not make sure that he is given exactly seven - no more, no less?

Division of drug packaging

Probably, it will seem to many that the answer to the above question is obvious, but not everything is so simple. Yes, there are arguments in favor of the possibility of a “blister release” - we have already identified them - but there are also arguments against. Let's start the presentation of counterarguments with the following question: if the dispensing of medicinal products not in secondary packaging is still allowed in cases specified by law, then what should be a signal for the primary distributor that such dispensing is possible?

Medicines are divided into prescription and non-prescription drugs, and in the context of the topic under consideration, these are two different stories. In the first case, the situation seems clearer - information about the non-multiplicity of the number of tablets / capsules / ampoules prescribed to the patient in the usual factory packaging is received by the first-timer from a prescription that comes to him from the hands of a pharmacy visitor (or, in the foreseeable future, electronically).

A lot has been said about how “willingly” treating specialists write out prescriptions, how often they are incorrectly formatted and unreadable. And nothing has changed. And this is not so much a “sin” of doctors as a consequence of shortcomings in the organization of healthcare. But now the conversation is not about this, but about the fact that many problems of drug supply and optimal pharmacy service simply rest on the fact that doctors do not write prescriptions properly.

And if the prescription is not written out and not presented to the first-timer, then there can be no account of the individual course of treatment of this particular patient, since this would be a double violation of the licensing requirements and conditions: “dispensing a prescription drug without a prescription” and “dispensing a drug in violation of the secondary packaging without sufficient grounds to do so." In a word, you first need to solve the problem of proper prescription writing, and then proceed to the one that we are considering in this article.

If, however, we are talking about any over-the-counter drug, then in this case the instruction to the pervostolnik to release it in a “non-standard quantity” will come not from a doctor, but from a citizen (buyer) self-medicating. And here, pharmacists and pharmacists will need clear and unambiguous instructions in which situations it is possible to “share” a package of medicines and release blisters, and in which not.

Frankly, in the case of over-the-counter drugs, the answer “none” especially suggests itself, otherwise there will be no end to the wishes of buyers to “split” this or that drug - because almost everyone always wants to “save”, regardless of whether the economy and personal income rise or crisis. However, a problem in this regard is created by preparations similar to the laxative F., which we talked about above: secondary packaging - - sometimes quite large in volume - - containing twenty, twenty-five, and sometimes more sachets or blisters. For example, in the secondary packaging of another well-known laxative C. contains twenty blisters and five hundred tablets. In most cases, one buyer does not need so much, even regardless of the price.

Questions and difficulties

If the Ministry of Health nevertheless expands the possibilities of “division” of secondary medicinal packages, then this will create many additional responsibilities and difficulties for pharmacy organizations. The release of the drug in this case does not mean at all that the pervostolnik gives the buyer one or two blisters, and that's it. Firstly, it is necessary to attach the instructions, which means that it must be duplicated, since the package inserts are usually delivered to pharmacies at the rate of “one secondary package - one insert”.

Secondly, the blisters will most likely need to be placed in a pharmacy package (mentioned in clause 2.8 of order No. 785), on which it is necessary to indicate the name, series of the drug, expiration date, etc. All this will take the first-timer a lot of time, especially if cases "Irregular holidays" will occur frequently. The consequence of this will be a slowdown in the first-table work; a slight decrease in the "throughput" of the pharmacy is also not excluded. It is likely that additional regulation of the concept of "pharmacy packaging" will be required.

With all obviousness, another problem will arise, which can be demonstrated by the above example of the above-mentioned antibiotic T., which is present in the assortment of Russian pharmacies in secondary packages containing five or ten tablets. If the patient is prescribed a course of seven tablets, then the blister will need to be divided. Is it possible to do this? Is this a violation of the primary packaging (which is unacceptable in any case)? Most likely it is. If the proposed change in drug dispensing legislation does occur, it should answer these questions.

The example with the antibiotic T. allows us to identify another important problem of “fractional release” - what to do with the remaining blisters / tablets / ampoules. After all, they may not be in demand later. All subsequent purchasers of the drug in a particular pharmacy may have a medical prescription that is the same as or a multiple of the secondary packaging. As a result, the tablets of the drug remaining after the only “fractional” purchase will become a loss for the pharmacy organization.

Vacation in a container

In connection with the topic under consideration, specialists familiar with foreign dispensing practices may recall that in many countries of America and Asia, drugs of some forms - in particular, tablets and capsules - go to pharmacies "angro" (from the French "en gros") - that is, "in large quantities", usually in the amount of a thousand pieces, in a large plastic container.

In such a system, the responsibility for filling the required number of tablets/capsules lies with the pharmacist, and the concept of “secondary packaging of the medicinal product” is absent in relation to this part of the drug assortment. Her role is essentially played by an individual (separate for each customer) container, where the pharmacist places the number of tablets counted according to the doctor's prescription. This container to a certain extent corresponds to the concept of "pharmacy packaging" of clause 2.8 of order No. 785. The pharmacist signs it, thereby transmitting to the buyer the necessary information about the drug prescribed to him, and also certifies it with his own signature.

In those states of America and Asia where there is a similar scheme of packaging, packaging and dispensing of medicines, it has traditionally formed. In Russia, a different order has developed - with primary and secondary packaging - - one that is typical for European countries.

The first method seems convenient and flexible from the point of view of fulfilling any medical prescriptions to the pharmacist, including "non-standard" courses of treatment. However, it has a significant flaw in terms of pharmacy service - more precisely, the duration of service for each customer and the speed of the "flow" of pharmacy visitors in general.

In order to carefully count and double-check the required number of tablets, place them in a container, properly arrange it, it takes time - as practice shows, in a queue sometimes up to fifteen or even twenty minutes. If the pharmacy is located in a large shopping center, often the buyer is given a signaling device like a pager for this time, which notifies him that the order according to his prescription has been filled. And yet, complaints and lamentations about the fact that we had to wait too long for the medicine do happen. With the same method of packaging, packaging of medicines and their dispensing, which has developed in the pharmaceutical industry of European countries - in particular Russia - there is no such problem.

Without scissors

In a word, the problem of "division" or "week" of secondary medicinal packages is quite complex and very ambiguous. Before making any decision, it is worth studying the experience of some neighboring countries, where, due to the low solvency of the population, scissors for dividing a blister into parts have become one of the attributes of the first table. Drastic legislative changes - for example, the introduction of a binding norm to “divide” at the request of the buyer packages of over-the-counter drugs are hardly appropriate and productive. This can lead to a surge in irresponsible self-medication. It would probably be worth starting by clarifying the phrase "in exceptional cases" of paragraph 2.8 of Order No. 785. And, perhaps, this will be limited to this for now.

Packaging and are divided into several types and groups. This division depends on the materials used, their mechanical strength and stability, which ensure maximum safety of medicines. Domestic state standards provide for several types of packaging, including packaging material. For medicines, there are the following types of primary packaging and packaging of plant materials - rigid, semi-rigid and soft.

Rigid primary packaging, in turn, is made of various materials. It can be metal - jars, test tubes (for storing capsules, granules, powders, dragees, tablets), pipes, aerosol cans, etc. Jars, vials, test tubes, bottles, ampoules are made of glass. Polymers are used for the manufacture of jars, cups, test tubes.

Packaging of drugs in semi-rigid packaging involves the use of cardboard, polymers and combined materials. The packaging of herbal medicines or plasters is carried out in cardboard. Polymers are used to make special syringe tubes for packaging medicinal plant materials intended for injection. They also make a tube-dropper, which contains eye drops. In combined materials is carried out packaging of medicines vegetable origin, granules, powders, capsules and others. Soft packaging is made from polymers and paper. It packs plasters, powders, herbal preparations, tablets, etc.

Absolutely all types of packaging, packaging and packaging materials must be selected based on their properties and qualities, the quantity and purpose of medicines, as well as in strict accordance with state standards and pharmacopeia requirements. As for our country, all the materials from which the primary packaging for the packaging of medicines is made are allowed for use only after they have been approved by the Russian Ministry of Health.

For each series of medicinal products, a single form of packaging should be used, which is selected taking into account their physical and chemical characteristics. For instance:

  • packaging of medicines and preparations that are too sensitive to the effects of bright light should be carried out only in light-tight containers;
  • if medicinal products contain volatile, oxidizing, hygroscopic or easily weathered substances, they must be packaged in vials or jars, which are tightly sealed with special stoppers or lids, and are also equipped with special sealing gaskets;
  • if such medicinal products are intended for export, then they are packed in containers closed with rolling caps to ensure maximum safety and security of others;
  • packaging of medicines in tablets that contain essential oils, it is carried out in test tubes, but first they are wrapped in paraffin paper.

In this case, the use of viscose carding tape or hygroscopic medical cotton wool is allowed.

In addition to the primary, there is also a secondary package, which is intended to protect the inner packaging and create an attractive appearance of medicines. The main types of secondary packaging are as follows:

  • cardboard - packs and boxes for ampoules, aerosol cans, bottles, vials, test tubes, syringe tubes, etc. are made from it;
  • polymeric materials - they are used for the manufacture of contour packaging, in which vials, ampoules with medicines, syringe-tubes are placed.

If the primary packaging provides for opening with the help of any means, then they must be enclosed in the secondary container. For example, a special device is inserted into each box with ampoules to open them.

Consumer packaging with packaged medicinal herbal raw materials is packed in group containers - boxes, cardboard boxes. Glass objects are additionally packed in shrink film.