The question of what temperature should be maintained in pharmaceutical refrigeratoris fundamental for any pharmacy or medical warehouse. Errors in setting up regimens can lead to damage to expensive drugs, and in some cases, to a threat to the lives of patients. That is why control of climatic parameters is in first place in the list of tasks of pharmaceutical supervision.
Modern equipment allows installation and maintenance exact meaning with an error of up to a fraction of a degree, but an understanding of the physical and chemical processes occurring inside the chamber is necessary for every specialist. In this article we will analyze in detail all the nuances of thermoregulation, legal requirements and features of the operation of equipment for different groups of medications.
Understanding the principles of operation refrigeration equipment is not just a formality, but a safety requirement. Let's look at what standards are in force today and how to apply them correctly in practice.
Standard temperature conditions according to GOST
The main document regulating the storage conditions of medicines in the Russian Federation is GOST R 58372-2019. According to this standard, the standard storage temperature for most drugs is from +2 to +8 degrees Celsius. This is the so-called “gold standard” of pharmacy, ensuring the stability of most chemical compounds.
It is important to note that the range of 6 degrees (from 2 to 8) was not chosen by chance. It allows you to compensate for short-term fluctuations when opening the door or loading new batches of goods. However arithmetic mean value temperatures should tend to +5°C. It is this indicator that is considered optimal for the long-term preservation of the properties of vaccines and serums.
⚠️ Attention: Short-term departure from the range (for example, up to +10°C with the door open) is permissible only for the time specified in the instructions for a specific drug. Long-term violation of the regime requires a quality examination.
Control over compliance with these standards is carried out using thermostat a monitoring system. Modern models are equipped with sensors that detect the slightest deviations and give an audible signal. Ignoring such signals is unacceptable and may entail administrative liability.
Storage specifics for vaccines and immunobiological preparations
Vaccines are one of the most sensitive groups of goods. For them, it is critical not only to comply with the upper limit, but also to avoid freezing. If liquid vaccine freezes, it will lose its immunogenic properties and become useless, and sometimes dangerous.
To store such preparations, it is recommended to use equipment marked “for vaccines” or refrigerators with forced air circulation, where there is a temperature difference in different zones is minimal. Static cooling in this case it is less preferable due to the risk of the formation of zones with lower temperatures at the rear wall.
- 🌡️ Strictly ensure that the preparations do not touch the walls of the chamber, where the temperature can drop below +2°C.
- 💉 Place vaccines on the middle shelf, away from air vents.
- 📉 Use thermal indicators (VVMs) that change color when critically heated or frozen.
Particular attention should be paid to transportation. Even if everything is perfect, a violation of the “cold chain” during delivery can ruin the entire stock. Therefore, acceptance of goods should begin with checking the thermal indicators on the packaging. pharmaceutical refrigerator everything is perfect, a violation of the “cold chain” during delivery can ruin the entire stock. Therefore, acceptance of goods should begin with checking the temperature indicators on the packaging.
What is a VVM indicator?
This is a heat-sensitive label that irreversibly changes color if the vaccine is exposed to elevated temperatures. The square inside the circle darkens faster when heated. If the square becomes equal to the circle or becomes darker, the drug cannot be used.
Frozen drugs and freezers
A number of medicines, including some types of vaccines, reagents and blood plasma, require storage at subzero temperatures. The standard mode for such cases is the range from -15 to -25 degrees Celsius. In some cases, for example, for long-term storage of certain biological materials, a regime of deep freezing down to -60°C or even -80°C is required.
The use of household freezers for these purposes is prohibited, since they are not able to ensure temperature stability and do not have the necessary documentation for pharmaceutical licensing. Professional equipment is equipped with systems No Frost or fans that prevent the formation of an ice crust that can damage the packaging.
⚠️ Attention: When defrosting the freezer, it is necessary to ensure in advance that the drugs are transferred to another working refrigerator with a similar temperature regime. Simply turning off the power is unacceptable.
Temperature control in freezers is carried out as strictly as in positive chambers. Sensors should be placed in the area where the temperature is highest (usually closer to the door) to ensure that even in “warm” areas, storage conditions are met.
Temperature classification table
For the convenience of systematizing the storage requirements for various groups of drugs, the following classification is used. It helps to quickly determine in which chamber a particular medication should be placed.
| Storage mode | Temperature range (°C) | Examples of drugs | Equipment type |
|---|---|---|---|
| Frozen | from -25 to -15 | Vaccines (some), plasma | Freezer |
| Refrigerated | from +2 to +8 | Insulins, most vaccines | Refrigerator |
| Cool | from +8 to +15 | Candles, some ointments | Refrigerator (setting) |
| Room | up to +25 | Tablets, capsules | Rack/Closet |
For example, a number of biological substances can be stored at temperature from +2 to +6°C, which requires more fine-tuning of the equipment.
☑️ Checking the temperature regime
Requirements for equipment and validation
A pharmaceutical refrigerator is not just a household appliance painted white. This is a complex technical device that must undergo a procedure validation. Validation confirms that the equipment is capable of maintaining a given temperature regime throughout the entire useful volume of the chamber, and not just at the point where the sensor is installed.
When choosing equipment, pay attention to the presence of the function digital stabilization and the ability to connect external sensors. The alarm system is also critical. It must work autonomously, even if the main power is turned off, relying on the built-in battery.
- 🔋 Availability of autonomous power supply for alarm (minimum 24-72 hours).
- 📄 Validation passport and GOST R certificate of conformity 58372-2019.
- 🌬️ Forced air circulation system for uniform cooling.
Regular verification of thermometers and thermographs installed in the chambers is a mandatory procedure. The verification frequency is usually one year. The use of devices with an expired verification period is equivalent to a lack of temperature control.
Typical problems and their solutions
During operation, pharmacy employees may encounter various problems. One of the most common is ice freezing on the back wall. This indicates a violation of the tightness of the seals or a malfunction of the defrost system. The ice coat acts as a heat insulator, forcing the compressor to work harder, but at the same time the temperature inside the chamber can rise.
Another common problem is the discrepancy between the readings of the built-in thermometer and an independent verified thermometer. In this case, you must be guided by the readings of a verified device, and send the equipment to service for calibration controller.
⚠️ Attention: Never try to repair the refrigeration circuit or change the refrigerant yourself. This requires a license and special equipment. If you suspect a freon leak, call a technician immediately.
Noisy operation of the compressor or vibration may indicate wear on the shock absorbers or mounting problems. In a pharmacy setting, where silence is important for the work of pharmacists, this becomes a significant factor in comfort.
Documentation and temperature logs
Maintaining temperature logs is a legal obligation. Records must be made regularly, at least twice a day (morning and evening), even if an automatic monitoring system is used. Electronic logs must be protected from editing past records.
The log records not only current readings, but also personnel actions in case of deviations. If temperature exceeded the limits norms, it is necessary to record the time of detection, the measures taken (for example, moving drugs to a backup refrigerator) and the result. The absence of such records during an inspection by Roszdravnadzor leads to fines.
Storage of logs (paper or electronic) should be carried out for a period of time the period established by the internal regulations of the pharmacy, but not less than the expiration date of the stored drugs. Digitalization of processes allows you to instantly generate reports for any period.
Frequently asked questions (FAQ)
Can medicines be stored in a regular household refrigerator?
The use of household refrigerators for storing medicines in commercial pharmacies is prohibited by licensing requirements. They do not ensure uniform temperature distribution, do not have the necessary documentation and alarm system required by GOST.
What to do if the electricity is turned off?
Do not open the refrigerator door unless absolutely necessary. A working pharmaceutical refrigerator can maintain temperature for 24-48 hours (depending on the model and load). If the outage is long, it is necessary to use a generator or urgently evacuate the drugs into thermal containers.
How often do you need to defrost?
Modern pharmaceutical refrigerators with the No Frost system do not require manual defrosting. Models with static cooling are defrosted as an ice crust forms (usually 1-2 times a year), but only after the drugs are moved to the reserve.
Where should the temperature sensor be located?
The sensor should be located in the air environment of the chamber, in the area where the temperature is highest (usually the upper part near the door), but not on the shelf with the drugs itself. This ensures that even in the “warmest” point, storage conditions are met.
Is a separate license required for installing a refrigerator?
A license is required for pharmaceutical activities in general. The refrigerator itself is not licensed, but it must be included in the list of pharmacy equipment, have a passport, a certificate of conformity and a valid passport for validating temperature fields.