Proper organization of storage of immunobiological preparations (IMP) is a critical aspect of the work of any medical institution, pharmacy or laboratory. Cold chain must be observed at all stages, starting from manufacturer and ending with the administration of the drug to the patient. Violation of the temperature regime, even for a short time, can lead to irreversible changes in the structure of the proteins contained in the vaccine, making it ineffective or even hazardous to health.
One of the key tasks of the personnel responsible for storage is the clear and unambiguous identification of the contents of refrigeration equipment. Visual marking shelves allows you to instantly determine which drug is located where, what its temperature is and when the expiration date expires. This minimizes the risk of medical error and helps to comply with the FIFO principle (first in, first out).
In this article we will examine in detail the requirements of regulatory documents, types of materials used and practical recommendations for design Storage zones. You will learn how to create a system that will be understandable to any employee, even those working on the night shift or in stressful situations.
Regulatory requirements and labeling standards
The main document regulating the storage of medical immunobiological drugs in the Russian Federation is sanitary rules SP 3.3.2.3332-16. According to these rules, each refrigeration equipment intended for UTI must be equipped with temperature indicators and thermometers, and also be clearly labeled. However, the requirements for the internal space are also strict.
⚠️ Attention: The absence of markings on the shelves of the refrigerator is equivalent to a violation of storage conditions and may become the basis for issuing an order by the inspection bodies of Rospotrebnadzor.
Marking must be done in such a way as to eliminate the possibility of confusion between drugs with different temperature conditions. For example, vaccines that require temperature storage +2..+8 °Cshould never be placed next to frozen drugs or on shelves where the temperature is not controlled. Visual zoning helps to comply with these requirements.
In addition, on each shelf or in the immediate vicinity there should be information about the drugs being placed. This could be a list of titles or color coding. The use of standardized labels allows you to quickly take inventory and control expiration dates, which is especially important for drugs with a short period of sale after opening the bottle.
Selection of materials for labels and stickers
The environment inside the refrigerator for vaccines is characterized by high humidity and low temperatures. Under such conditions, ordinary paper quickly becomes unusable: it gets wet, loses its adhesiveness and becomes unreadable. Therefore, to label shelves it is necessary to use specialized materials that are resistant to condensation and temperature changes.
The optimal solution is labels made of synthetic materials such as polypropylene or polyester. They have high adhesion to plastic and metal surfaces of shelves and do not deform over time. Thermal transfer printing on such materials ensures text resistance to abrasion and the effects of disinfectant solutions that are regularly wiped with surfaces.
It is also worth considering the option of using magnetic holders with insert pockets. This allows you to change drug information without reprinting new labels. You can put a sheet in your pocket with an up-to-date list of vaccines on a given shelf, or with a graph of temperature conditions. The main requirement is that the transparency of the pocket should allow information to be read without opening the refrigerator.
- 🏷️ Polypropylene self-adhesive labels - resistant to moisture and grease.
- 🧲 Magnetic pockets with transparent film - convenient for frequent data changes.
- 🖨️ Laminated badges are a budget option, but require high-quality sealing of the edges.
- 🎨 Color coding - the use of color stickers for different temperature groups.
Color coding and zoning system
To simplify navigation and reduce the risk of errors, it is recommended to implement color coding system. This is especially true in large refrigerators or refrigerators, where drugs from different manufacturers and with different storage conditions are stored. Visual signal is perceived by the brain faster than text.
For example, you can select shelves for storing vaccines that require strict adherence to the regime +2..+8 °C, red or orange edging on labels. Drugs that can be stored for a short time at room temperature, but are kept in the refrigerator for storage, can be marked green. Frozen vaccines (if stored in the same volume, which is not recommended, but possible in emergency situations) should be labeled bright blue or purple.
It is important that the selected system is described in the standard operating procedures (SOP) of the organization and brought to the attention of all personnel. Unified standard allows a new employee to immediately find his way around without asking colleagues again. You can also place pictograms on the shelves prohibiting the storage of food or other foreign objects.
| Marker color | Temperature range | Type of drugs | Action when violation |
|---|---|---|---|
| 🔴 Red | +2..+8 °C | Most vaccines (DPT, Hepatitis B) | Quarantine, thermal indicator assessment |
| 🔵 Blue | -20..-10 °C | Frozen vaccines (OPV, some influenza) | Do not defrost, check temperature |
| 🟢 Green | +8..+15 °C | Drugs with a wide range (rarely) | Move to the correct mode |
| 🟡 Yellow | Any | Drugs with expiring dates (< 1 month) | Urgent use or disposal |
Algorithm for applying and updating information
Labelling process shelves should be built into the routine procedures of medical staff. When a new batch of vaccines arrives, the person in charge must not only check the temperature sheet, but also update the information on the shelves. If a pocket system is used, the liner is replaced. If stickers are used, place a new one on top of the old one (if space and readability allows) or next to it.
It is strictly forbidden to cover thermostat sensors or ventilation holes with labels. This may lead to incorrect operation of the equipment and disruption air circulation. The marking is applied to the front end of the shelf or to the vertical counter of the refrigerator at eye level so as not to block the view of the contents.
☑️ Marking checklist
Updating information is also required when changing the nomenclature of stored drugs. If space on the shelf is running out and another type of vaccine is planned to be placed, the old labeling must be dismantled. Data relevance is a guarantee of safety. In modern conditions, many institutions are switching to QR codes, which lead to an electronic warehouse card, which allows you to see balances and deadlines in real time.
Marking features for different types of refrigerators
The configuration of the refrigeration equipment affects the labeling method. In top-loading refrigerators (cabinets), it is convenient to use long horizontal labels at the ends of the shelves. In horizontal-loading refrigerators (chests), which are often used for frozen vaccines, markings are applied to the inner sides or on special baskets, since shelves there may be absent or removable.
For thermal containersused for transportation, the marking of shelves (if they are inside) must be especially resistant, since they are often subject to mechanical stress. Here it is better to use engraving on plastic or stickers with a protective varnish coating.
⚠️ Attention: In chest refrigerators with blind lids, the markings should be duplicated on the outside of the lid or at the end, so that there is no need to open the chamber to search for the desired drug, which prevents loss of cold.
If an institution uses refrigerators of different models (Biryusa, Pozis, Atlant or specialized medical cabinets), it is recommended to unify the labeling system for all units of equipment. This will create a unified information space and reduce the cognitive load on employees when moving between offices.
Control and audit of the storage system
The presence of labeling is not a one-time action, but a process that requires constant monitoring. Regular audits (self-tests) should include checking the condition of labels. Lost, faded or dirty stickers must be replaced immediately. Internal control helps to avoid fines during external audits.
During the audit, the compliance of the actual placement of drugs with the declared labeling is also checked. Cases where Pentaxim ampoules are on a shelf labeled “Grippopak” are unacceptable. Such confusion can lead to fatal vaccination errors. The person in charge of the refrigeration equipment should check weekly for the presence and location of UTIs.
What to do if the markings are worn off?
If you find that the label on a shelf is unreadable, immediately isolate the medications on that shelf in a separate container with a temporary marking. Print a new label only after confirming the storage conditions and the exact name of the drugs. Do not leave vaccines unidentified, even for a short time.
An effective vaccine refrigerator shelf labeling system is an investment in patient safety and the health care facility's reputation. It requires minimal financial costs, but has a tremendous effect in organizing the work process. The introduction of clear rules and their observance by each employee guarantees the safety cold chain and effectiveness of the immunoprophylaxis.
Can I use regular tape to secure labels?
Using regular office tape is not recommended. At low temperatures it becomes brittle and peels off, and when defrosted or wiped with alcohol it loses its transparency and stickiness. Use specialized self-adhesive materials or lamination.
How often do labels on shelves need to be changed?
Planned replacement is not required if the label remains legible. Unscheduled replacement is made when the range of vaccines changes, the label is damaged, or based on the results of an internal storage quality check.
Is it necessary to label each shelf if they contain the same vaccines?
Yes, each shelf needs to be labeled. This eliminates the possibility of an error if one of the shelves is temporarily removed for washing or the preparations are rearranged. The employee must see the information without looking at other levels.
Is it allowed to write information by hand?
SanPiN does not prohibit handwritten text, but requires its clarity and durability. However, typewritten or printed text is preferable as it is easier to read and looks more professional. Handwritten changes to finished labels must be certified by the signature of the person responsible.