Temperature no higher than 30 c. Room temperature according to the labor code at different times of the year. When the medicine turns into a "dummy"

home What should the temperature be in the freezer?

To store frozen food, food industry experts recommend setting the freezer to -18°C. Why was this particular temperature chosen? We have prepared several interesting facts

about this temperature standard and the reasons for its introduction among food and refrigeration equipment manufacturers.

During the development of refrigeration technology, -10°C was considered the optimal temperature for storing frozen food. However, later this indicator changed: the advantages of low temperatures in the freezer were identified. In the late 1930s, the American Fruit and Vegetable Association proposed a temperature of 0°F (-17.8°C) as the standard for storing frozen foods. The decision was made due to the fact that 0 is a round number, and not for any other scientific reasons. Over time, this temperature, rounded down to -18°C Celsius, was established as the standard for freezer storage of frozen food in Europe.

What should be the optimal temperature in the freezer according to the EU directive?

In 1964, the International Academy of Refrigeration recommended -18°C as the minimum temperature for storing frozen foods. National and international committees agreed with the proposed recommendations and adopted this freezer temperature into standards, regulations and laws. Then, based on the “Regulations and Regulations for Frozen Foods” adopted in 1967, the European Union Commission created its own directive for quick-frozen foods, and in 1989 a minimum temperature level of -18 ° C was introduced for storing frozen food. Actually low temperatures in the freezer reduce the rate of chemical reactions and the spread of microorganisms. Although there is no exact relationship between the rate of reactions and a decrease in temperature, van't Hoff's rule is often used for calculations, since with some error it can show the dependence of temperature and flow rate in foods (the rate of chemical reactions doubles or more for every 10°C increase in temperature).

Experts have found that at low freezer temperatures (-30°C to -18°C) the speed chemical reaction in fruits and vegetables it slows down two to three times. For sensitive substances, this means that the vitamin content decreases much faster at high temperatures than at optimal temperatures. After one year of storage at -12°C, the vitamin C content of vegetables is about 20% of that in foods stored at -18°C in the freezer. The colder the air in the freezer, the better quality frozen foods.

Thus, the answer to the question: “What should be the temperature in the freezer?” — is the value -18°C. It is considered a trade-off between food quality and power consumption, since lower temperatures lead to increased power consumption of the device.

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In the field of drug circulation, there is no more commonly used set of cliched phrases than storage conditions. They are mentioned everywhere: on the packaging of substances, on secondary packaging medicinal product, in licensing conditions, in guidelines on good practices, regulatory instructions for the circulation of different categories of medicines, etc. Whenever we talk about “controlled storage conditions,” everyone understands by them the conditions (for example, humidity, temperature, light) that must be ensured during transportation, storage and use of the medicinal product based on the manufacturer’s recommendations. Everything is clear, but the wording is confusing. Starting to think about them more deeply, many questions arise, for example: “no more than +25 °C?”, And then how much will be “no less”?; “dry place”, and when is it already “wet”?; “cool place”, isn’t this “cold”?; “a place protected from light” is probably a dark place? This is not only a domestic problem. Similar phrases abroad: “ Do not store above 25° WITH" or " Store below 25° With in a dry place", sometimes added " " and (or) " Protect from light”, although often there is no information about storage conditions at all.

They are widely used, found everywhere, but many people make mistakes with them. There is no well-structured guide to interpreting storage conditions. Therefore, market participants continue to wait for detailed clarifications from regulatory authorities, and the last one lives the thought that everything is obvious and understandable from.

The very idea for this article is aimed at understanding. This is an attempt to activate the process of public discussion of the formulations used by everyone regarding the storage conditions of medicines (APS and FPPs). This is important, if only because violation of storage conditions, due to their misunderstanding, is a known reason for the majority of medicines recalled from the market.

Storage temperature

Let's start with something simple. All storage temperature conditions are clearly standardized. This has always been important to ensure the uniformity of requirements for warehouse and transport infrastructure, to maintain product quality at all stages of its supply chain, regardless of the geography of supplies. Since 1970, only three temperature ranges have been agreed upon internationally for the storage of thermolabile products, including:

• room temperature (+20 °C),
• refrigerator (+5 °C) and
• freezer (-20 °C).

Acceptable intervals and recommendations for wording temperature regime storage are presented in Table 1. Often these modes alone are not enough; it is necessary to take into account the characteristics of dosage forms, packaging materials, regional regulations, climate and even frequent changes in weather. This has led to the introduction of additional regimes at the local level. For medicines this is:

• From -5 to -18 °C;
• Not higher than +8 °C;
• Not lower than +8 °C;
• Not higher than +15 °C;
• From +15 to +25 °C and
• Not higher than +30 °C.

Each of them is a special case of one of the three main temperature regimes indicated in the table. So, storage conditions from -5 to -18° WITH This is a special case for storage in the freezer. If the standards of the USSR, and subsequently the standards of the CIS countries, assume storage in the freezer mainly in the range of -18-24 ° C, then Western countries(EU, USA) approach this issue from the perspective of energy efficiency. It should not be forgotten that Soviet standards also provided for similar low-temperature storage modes (-6; -12; -18 °C)

Storage conditions at a temperature not higher than +8 ° WITH – this is the same basic storage mode in the refrigerator (+2...+8 °C), only not so strict minimum temperature and typical for products that are not afraid of possible freezing (sub-zero temperatures). Storage at a temperature not lower than +8 ° WITH on the contrary, it assumes that the product is not allowed to cool, which means it cannot be placed in a regular household refrigerator. Sometimes these conditions are confused with storage mode +8+15 °C (cool place). This is not true. Whenever a one-sided interval is declared, the emphasis is placed on the specified value. So, storage at a temperature not lower than +8 °C is a special case of storage at room temperature (from +8 to +25 °C). And here is the condition “ ° WITH “, is a special case of storing products (mainly substances, semi-finished products) in a refrigerator, when storage in it is a priority, but less stringent temperature conditions are allowed at the stages of circulation (for example, ST, T class refrigerators). This mode is interpreted as storage at a temperature of +2+15 °C.

Widely known mode " Store at temperatures from +15 to +25 ° WITH » – a special case of storage at room temperature, but is used exclusively in a professional environment to maintain the operating parameters of the ventilation and air conditioning system in the warehouse area. For the consumer, such a phrase cannot be acceptable due to his lack of temperature control within the specified range.

The declared mode " Store at a temperature not exceeding +30 ° WITH » is also a special case of storage at room temperature, expanding its range to +30 °C only for end consumers living in climate zones III and (or) IV (A, B). For subjects of the drug circulation market, such conditions on packaging still always mean storage in a controlled range of +15+25 °C.

Room temperature

Two of the three main modes, the freezer and the refrigerator, are artificially supported systems, and the issues of their functioning do not cause much controversy among specialists. However, the third mode - room temperature - requires a more careful approach due to high natural variability.

Just two decades ago, a simple phrase was used to indicate storage conditions: “ Store at room temperature " However, at the stage of harmonization of requirements for medicines within the ICH ( abbreviation from English International Conference on Harmonization of Technical Requirement for registration of pharmaceuticals for human use)(since 1991) this term had to be abandoned, replacing it with “ Store at a temperature not exceeding +25 ° WITH " This is due to the differences between the ICH regions, each of which has a different range for the official interpretation of room temperature. For example, in the United States, room temperature is considered to be between +15 and +30 °C, in European countries from +15 to +25 °C, and in Japan generally from +1 to +30 °C.

After updating ICH Q1 documents, room temperature is considered to be the temperature range from +2 to +25 °C for countries of the world located in climate zones I and II, or the range from +2 to +30 °C for countries from III, IVA and IVB climatic zones respectively. Distribution of countries by climatic zones suggested in guidelines World Organization health care

Where to look for a cool place?

Until now, storage conditions " V cool place» declared for storage of medicinal products. Domestic specialists are well familiar with these conditions, with a range of +8+15 °C, from tinctures, for which in the State Fund of the USSR XI ed. storage conditions in a cool place were stated. Again, it cannot be said that this is a unique domestic practice. Similar storage conditions are declared in both the USA and the UK, where the phrase “ Store in cool, dry place».

The problem is different. There are differences between our countries in the perception of this temperature range. For example, the European Pharmacopoeia does not provide for such conditions for commercial medicinal products. The term “cool place” itself is present, but with the caveat that its use is applicable when describing analytical methods in pharmacopoeial monographs. There are no such storage conditions in the ICH Q1 guidelines, which establish rules for stability studies of all drugs according to one of three standardized regimens (see table). But the USA (USP-NF) does not exclude them. Pharmacopoeial article " General requirements and notes" USP interprets "cool place" as "a place with a temperature of +8 to +15 ° C" and the caveat that "the drug for which such storage is intended can also be stored in the refrigerator, unless otherwise specified in the private pharmacopoeial monograph" . A similar interpretation is proposed in WHO guidelines as “ Store at a temperature not exceeding +15° WITH"(from +2 to +15 °C) and in the new Russian Pharmacopoeia GF XIII ed. . But these conditions are not exactly the same (see above). It turns out that in international practice, in contrast to Soviet standards, storage in a cool place is considered as a special case, such a kind of intermediate regime between the refrigerator (from +2 to +8 °C) and room temperature (from +2 to +25 °C), suggesting storage in the range from +2 to +15 °C. And only the declared conditions " Store at a temperature not exceeding +15 ° C, do not allow cooling "will correspond to our usual regime of +8+15 °C.

Cool storage conditions are more typical for substances and intermediates in work in progress, reagents and samples in analytical tests. This is beneficial for suppliers of substances, since the product can be permanently stored in a stationary refrigeration chamber and transported in less harsh conditions of an isothermal body. This is necessary to clarify the conditions for handling reagents in the analytical laboratory. But this is inconvenient for finished products. Here this mode rather causes problems at the end of the distribution chain. For example, when selling in a pharmacy, it is necessary to constantly explain to the patient that the drug should be stored in the refrigerator or at room temperature, but away from sources of thermal radiation - this could be a cabinet in the kitchen, away from a gas or electric stove, or a wardrobe in the living room, which is located away from windows and the fireplace, and even the bedside table in the hallway... wherever there are no sources of thermal radiation.

How to find a problem for yourself?

The choice of storage temperature for a medicinal product is always made at the stage of its development and depends on many factors, not least commercial ones, for example: the purpose of the expiration date, logistics costs, special conditions treatment, etc. The choice of one of the three main storage modes ensures the same understanding of its temperature range for all subjects of the drug distribution chain, from the distributor to pharmacies and the patient. Declaring any other conditions may provoke their unintentional violation due to ignorance or misunderstanding, or lack of technical capabilities. It may happen that distributors and (or) pharmacies will not have an equipped area for non-standard storage, which means this will either automatically require costs for its creation and subsequent maintenance, or will increase the risk of improper storage of the drug in standard areas. For example, some domestic products still have a storage mode at a temperature of +18+20 °C. These are drugs " retirement age”, the standardization of which was carried out back in the times of the USSR according to the Global Fund IX - XI edition, when “room temperature meant storage at +18+20 ° C”, and manufacturers have still not ensured that their registration dossier is updated. I am sure that we are all interested in seeing how entities that still have licenses for wholesale and retail trade, ensure compliance with the stated conditions in a very narrow range of up to 2 ° C.

You never have to look for a problem. It is enough: 1) think a little, 2) study stability simultaneously in adjacent (standardized) temperature regimes and 3) choose the main regime or, at worst, its special case, which provides beneficial competitive advantages. The regulator must also: 1) think about all stakeholders (manufacturers, distributors, pharmacies and patients); 2) not allow registration with non-standard storage modes, and if a particular case is approved, 3) obtain convincing evidence of its necessity, the absence of an alternative, and 4) include explanations in the instructions for medical use and/or package insert.

The temperature is not the best a big problem in the interpretation of the declared storage conditions of medicines. Where more interesting story O protected from light And dry place.

Place protected from light

Often produced for the market of post-Soviet countries, contain the phrase “ Store in a place protected from light ».

Based on the definition provided in Pharmacopoeias, “if the product documentation indicates storage conditions in a “place protected from light”, this always means that measures should be taken to prevent exposure direct sunlight , any other bright light , and ultraviolet rays , for example, by using dishes made of special glass or other light-proof material, working in a darkened room, and even using furniture painted black on the inside, etc.”

This phrase does not have a clear explanation from domestic regulatory authorities. And it is precisely this that has been exciting all pharmacists for several decades. Firstly, it's unclear what it refers to, Secondly I don't know what we're afraid of. For example, what does the phrase “Keep away from light” indicated on the pack (secondary packaging) of the drug refer to? Maybe it refers to the pack itself, which contains the container with the medicine? Either to the container itself (primary packaging), or directly to the dosage form itself?

Such ridiculous questions, and the answer is obvious, but until now, in the inspection reports of pharmacies, inspectors from regulatory bodies of various subordination record violations such as: “At the time of the inspection, it was revealed that the drugs secondary consumer packaging which are indicated “Store away from light” were in a refrigerator with glass doors With direct access to artificial lighting”, beautifully accompanied by a subsequent order to eliminate the violation by “sealing the refrigerator door with an opaque film.” According to the inspectors, “display in display cases and on shelves in the sales area, including in refrigerators with glass doors, is only allowed empty secondary packaging, and drugs in primary packaging must be removed from them and stored in a closed cabinet, painted inside with black paint". – It’s written on the packaging! Read!

Here the following question arises: “Why? What are we afraid of? Indeed, light can affect the structure of substances, cause changes in them, provoke decomposition and deterioration of other critical characteristics. But, let me! This may be relevant for substances, whereas the drug is already in protective packaging and, obviously, the influence of light is exaggerated here.

Look at the world ones (USP, Eur.Ph.), look at the WHO and ICH guidelines. The following rule is stated everywhere: “ photosensitive medicinal products must be packaged in light-protective consumer packaging and ( or ) should be stored in a place protected from light." Responsibility for protecting the medicinal product from light always rests with the marketing authorization holder. It is he who must choose an acceptable method of protection: either by selecting the dosage form (for example, coating tablets, filling into hard capsules), or by packaging the drug in light-proof primary packaging (for example, aluminum tubes, foil, dark glass bottles, etc.) and ( or) protective secondary packaging. And then the phrase “Keep away from light” on the drug packaging essentially becomes useless for participants in the drug distribution chain, including the patient.

It is also useful to remember the request of the Novartis Consumer Health Switzerland company on the Russian market. In December 2003, in response to her request, the Institute for Standardization of Medicines, Moscow, at that time considered a specialized expert organization, provided the following explanations (ref. No. 1650 dated December 15, 2003): “Packaging of the drug in primary packaging such as bottles dark glass, aluminum tube, disposable bags made of a combined material polyethylene/aluminum foil/polyethylene/paper, opaque plastic bottle made of low-density polyethylene, opaque plastic tube with their subsequent insertion into secondary consumer packaging (box or cardboard pack) allows you to ensure storage conditions for the drug “in a place protected from light” with natural and artificial lighting in a pharmacy.”

This response is identical to the interpretation of foreign regulatory authorities, which recognize the placement of the dosage form within the primary and/or secondary packaging as a “light-protected location.” And only in exceptional cases, when such protection is impossible without loss of quality of the dosage form, it is necessary to choose the lesser evil and use the warning label “ Store in the original package" and (or) " Protect from light».

Returning to the question “What are we afraid of?” there is another answer. Direct sunlight, especially falling vertically (not tangentially) or a high-power artificial light source located in close proximity to the medicinal product, is not only capable of penetrating inside the container (this seems to have been sorted out), but will also heat the consumer, group and even transport packaging and its contents, thereby causing aging of the drug, negatively affecting its safety and effectiveness.

Therefore, the phrase “in a place protected from light” remains necessary for the text regulatory documents, establishing the requirements and rules for acceptance, storage, shipment and transportation of medicines. This means that the drug (regardless of the type of packaging) should not be exposed to the sun for a long time, including near windows in a warehouse or in receiving and (or) shipping areas, as well as near other light sources that generate strong thermal radiation.

And everything would be fine, but this is not the last problem with storing medicines. There is also a “dry place” - perhaps the most mysterious place on drug labeling.

Bibliography:

1. WHO guide to good storage practices for pharmaceuticals. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-seventh report. Geneva, World Health Organization, 2003, Annex 9 (WHO Technical Report Series, No. 908)
2. ICH Q1A(R2) Guideline Stability Testing of New Drug Substances and Products, 2003.
3. Stability testing of active pharmaceutical ingredients and finished pharmaceutical products, Annex 2, WHO Technical Report Series, No. 953, 2009
4. GF XIII State Pharmacopoeia of the Russian Federation, pp. 208-216, 2015
5. United States Pharmacopoeia (USP-NF)
6. GF XII, p. 212-213 (OFS 1.1.0010.15).
7. Instructions for organizing storage in pharmacies of various groups of medicines and products medical purposes, approved By Order of the Ministry of Health of the Russian Federation dated November 13, 1996 No. 377.
8. Rules for the storage and transportation of medicines, medical devices and medical equipment under conditions that ensure the preservation of their safety, effectiveness and quality, approved. By Decree of the Government of the Republic of Kazakhstan dated 23.12. 2011 No. 1595
9. Model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products, Annex 9, WHO Technical Report Series, No.961, 2011.
10. Stability testing: Photostability testing of new drug substances and products, ICH Q1B, 1996
11. GOST 16317-87 Refrigerating appliances. Electrical household. General technical conditions.

Where and at what temperature should medications be stored?

Every home probably has a first aid kit. As a rule, everything that was unfinished and underused after treatment is added there, as well as in reserve and just in case, whole and started packages, bottles with mixtures and tinctures, tubes with creams and ointments, etc. About how long medicines can be stored - the question, let’s say right away, is not difficult, just look at the expiration date on the packaging. But few people attach importance to the fact that the shelf life is sharply reduced when the medicine is opened, and if it does, they forget exactly when it was opened. (Of course, this applies to various tubes, jars, etc., where the medicine is stored, and not to tablets in plates, when each tablet is separately “packaged”).

Write the date you opened the medicine on the package. What happens after opening the package

Let's immediately figure out what each temperature range means?

Room temperature

From +15 to +25 degrees C

Cold or cool place

From +8 to + 15 degrees C

In a refrigerator

From +2 to +8 degrees C

Deep cooling

From -15 degrees C

Warm

From +40 to +50 degrees C

Hot

From +80 to +90 degrees C

Water bath

From +98 to +100 degrees C

Ice bath

0 degrees C

Sometimes the instructions for medications say: “store at a temperature not lower (or higher) than so many degrees,” the temperature range is as follows:

Recommended conditions (often listed in drug instructions)

What does it mean Store at a temperature not exceeding 30 degrees C

2 to 30 degrees C

What means Store at a temperature not exceeding 25 degrees C

2 to 25 degrees C

What means Store at a temperature not exceeding 15 degrees C

2 to 15 degrees C

What means Store at a temperature not exceeding 8 degrees C

2 to 8 degrees C

What means Store at a temperature not lower than 8 degrees C

8 to 25 degrees C

Actually, that's enough detailed information You can read about storing a specific drug in the instructions for it, so do not throw it away ahead of time.

After opening the drug, the medicine comes into contact with air, and oxidative processes begin. In addition, most drugs, except tablets, contain antimicrobial preservatives that decompose when exposed to air, which creates favorable conditions for the growth of dangerous bacteria in the drug. Tablets are also susceptible to bacterial attack, but this happens an order of magnitude slower.

Take out the tablets that are stored in the jar so that no moisture gets in there - with a dry spoon or simply shake it out into the palm of your hand, but try to pour out as much as required so that you don’t put extra tablets back later, thus contaminating the rest. Why do you need to comply with the deadlines? storage?

The fact is that after the expiration date, drugs not only lose their effectiveness, but can also cause harm to the body. The first danger when using expired medications is bacterial infection, which can cause digestive upset and skin rashes. In addition, in expired drugs there is a strong increase in the breakdown products of the main substance, which can affect the functioning of the kidneys, liver and bladder.

Under no circumstances should you store medications in the bathroom, on the refrigerator or near the stove. In other words, heat and moisture are the enemies of drugs; under such conditions they will deteriorate much faster.

One of the main tasks of the employer can be considered to provide a favorable microclimate in the workplace.

However, many employers do not comply with temperature requirements, thereby violating the law.

What should be the temperature in the room according to the Labor Code of the Russian Federation?

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Is the employer obligated to monitor the room temperature?

This question can be answered by Article 212, according to which the employer will be held administratively liable for sanitary work not carried out on time.

The list of these measures also includes compliance with the temperature regime established by Sanitary Norms and Rules (SanPiN), as it is too low or vice versa heat can lead to a decrease in energy levels and, as a result, its performance.

Accordingly, if an employer evades fulfilling this obligation, he violates the law and must be punished.

It can be said that the employer is obliged to monitor the temperature throughout the entire working period.

Temperature regimes by season, winter and summer

Room temperature in summer time according to the Labor Code should not be higher than:

• 28 degrees Celsius for 8 hours of operation.
• 30 degrees Celsius for 5 hours of operation.
• 31 degrees Celsius for 3 hours of operation.
• 32 degrees Celsius for 2 hours of operation.
• 32.5 degrees Celsius for 1 hour of operation.

Working at temperatures exceeding 32.5 degrees is considered dangerous. The employer has several options to avoid the heat, namely: install special equipment (air conditioners, fans) in the work premises or reduce the number of working hours by special order.

Video: If the heat in the workplace is above 26 degrees, you can leave work an hour earlier.

According to the Labor Code, the indoor temperature in winter should not fall below 20 degrees Celsius. If it does not meet the standards, the employer must install a heater in the workroom or reduce the number of working hours. The Labor Code establishes the following temporary standards at low temperatures:

• no more than 7 hours of operation at 19 degrees Celsius.
• no more than 6 hours of operation at 18 degrees Celsius.
• no more than 5 hours of operation at 17 degrees Celsius.
• no more than 4 hours of operation at 16 degrees Celsius.
• no more than 3 hours of operation at 15 degrees Celsius.
• no more than 2 hours of operation at 14 degrees Celsius.
• no more than 1 hour of operation at 13 degrees Celsius.

Labor standards have established that working in temperatures below 13 degrees Celsius is dangerous.

Summarizing the above data, we can say that the room temperature is summer period should not exceed 28 degrees Celsius, and in winter should not fall below 20 degrees Celsius.

What should an employee do if the employer does not comply with the temperature regime?

Salaried workers often face negligence from their employers. What to do in this case? There are several options:

• ask the employer to normalize the temperature using equipment (air conditioning, heater)
• demand a reduction in hours of work in accordance with regulations
• file a complaint with Rospotrebnadzor
• contact the labor inspectorate for help

In the last two options, a special inspection will be carried out at the place of work, during which it will be determined whether an offense has been committed.

As a result, we can say that the employee has several legal methods of influencing.

Video: Complaint against the employer and heat +31 in the workplace.

What punishment does an employer face for non-compliance with temperature conditions?

In accordance with the Code of Administrative offenses, the employer who violated sanitary standards, will be fined up to 20 thousand rubles, or its activities will be suspended for a certain period.