Professional Medical Refrigerators and Warmers for Transporting Blood, Vaccines, Medicines and Organs — Requirements, Standards and Our Offer

In healthcare, temperature stability is a matter of safety and compliance. Blood, vaccines, medicines, diagnostic samples and transplant organs must be stored and transported under strictly controlled conditions. A regular refrigerator is not enough. You need equipment that maintains the set temperature range with high stability and uniformity, works reliably in both heat and cold, and whose performance can be documented, mapped and validated.

Below you’ll find a complete overview of the regulatory requirements in Poland and ready-to-deploy HESTA solutions — purpose-built medical refrigerators and warmers.

1. Why a regular fridge is not enough

Low-cost camping coolers and household fridges do not meet the quality, stability and documentation requirements applicable in medical use. Medical applications require, among other things:

• maintaining a defined temperature range (e.g., 2–8°C) with typical stability of ±0.5–1.0°C,
• reliable operation across wide ambient temperatures (summer heat / winter cold),
• active heating to prevent over-cooling and to control ranges such as 20–25°C or 37°C,
• compatibility with external temperature data loggers holding a current calibration certificate,
• the ability to perform qualification and validation (IQ/OQ/PQ) as well as temperature mapping,
• optional over/under-temperature alarms, set-point lockout, and compliant data recording/archiving.

Consumer/tourist devices typically regulate “relative to ambient,” show large fluctuations and poor uniformity, and lack GxP documentation — they are not suitable for medical use.

2. Temperature ranges — different materials, different needs

HESTA devices are available across the ranges above, with combined cooling/heating control and the option to tailor temperature profiles.

3. Capacities — from 3 to 110 litres

We manufacture units from 3 to 110 litres:

• 14 L — Portable medical refrigerator 14 L
• 15 L — Medical refrigerator 15 L (12 V / 230 V, battery)
• 21 L — Portable refrigerator 21 L
• 27 L — Medical refrigerator 27 L with heating
• 37 L — Medical refrigerator 37 L
• up to 110 L — stationary/transport variants (made to order)

4. Ambient conditions — critical for correct operation

Medical fridges and warmers operate in ambulances, delivery vehicles, non-air-conditioned warehouses and in the field: typically from –10°C to +42°C (e.g., a sun-heated trunk).

• Please specify minimum and maximum ambient temperature,
• transport scenario (duration, stops, sun exposure),
• mobility requirements (handles, wheels, tie-downs).

5. Power and autonomy

• Power: 12 V DC, optional 24 V DC (vehicles) and 230 V AC (mains),
• Batteries: internal or external power packs,
• Automatic power source switchover,
• We prepare autonomy simulations for your use case (payload, ambient, duty cycle).

6. Safety features

• Temperature set-point lock and service access control,
• Two temperature profiles (e.g., 2–8°C and 20–25°C) switchable by key,
• optional alarms (relay outputs available),
• Works with data loggers holding a current calibration certificate,
• Data recording and archiving for audits.

7. Qualification and validation (IQ/OQ/PQ)

In regulated environments (GxP), devices used for storing and transporting medical materials should be qualified and validated. This includes blood and blood components, cold-chain medicines, diagnostic materials, and cells/tissues/organs.

• We supply documentation enabling full site qualification IQ/OQ/PQ,
• perform temperature mapping (varied loads, mapped probe points),
• and support integration with your quality system.

? Our devices undergo initial validation.
We can also carry out a full validation and qualification (IQ/OQ/PQ) after receiving the necessary quality system guidelines and documentation from the client.

8. Legal requirements and guidance (Poland)

Blood and blood components

• RBC storage temperature: +2°C to +6°C, continuous monitoring and documentation,
• Transport and storage per the quality procedures of the blood service unit,
• Key basis: Regulation of the Minister of Health of 7 March 2017 on quality and safety of human blood and blood components (Dz.U. 2017 poz. 646), as amended 16 Oct 2017 (Dz.U. 2017 poz. 2051). Guidance: Narodowe Centrum Krwi (NCK).

Medicines and vaccines (GDP/GSP)

• 24/7 monitoring, temperature alarms and calibrated sensors required (traceable to national standards),
• Maintain the 2–8°C cold chain for thermolabile products and 15–25°C for room-temperature products per SmPC,
• Basis: EU GDP 2013/C 343/01, Polish Pharmaceutical Law, and the Regulation of the Minister of Health of 13 March 2015 on Good Distribution Practice. Vaccine guidance: GIS, PZH/NIZP.

Medical laboratories

• Quality requirements and environmental condition records (incl. temperature) for samples and reagents,
• Basis: Regulation of the Minister of Health of 22 Dec 2022 on conditions for medical diagnostic laboratories (Dz.U. 2023 poz. 33). Professional guidance: KIDL.

Cells, tissues and organs (Poltransplant)

• Temperature control across the entire chain per centre procedures and the type of material,
• Basis: Regulation of the Minister of Health of 26 Oct 2018 (Dz.U. 2018 poz. 2060). Info: Poltransplant.

9. Organ transport

Depending on the organ, transport is typically under hypothermia at approx. +4°C for the duration of transfer (as per clinical SOP).

10. Why camping/household fridges won’t work

• They regulate relative to ambient — no stable set-point control,
• Large fluctuations and poor chamber uniformity,
• No automatic heating to prevent over-cooling,
• No validation/qualification, documentation or metrological traceability,
• Do not meet GDP, GIS or MoH/NCK requirements.

11. How to prepare your request

1. Target temperature range (2–6°C / 2–8°C / 15–25°C / 37°C / other),
2. Ambient conditions (min/max, sun exposure, vehicle type, vibration),
3. Power (12 V / 24 V DC / 230 V AC),
4. Required autonomy (time off-grid, use profile),
5. Capacity (3–110 L) and mobility (handles, wheels, tie-downs),
6. Data logger and calibration requirements,
7. Qualification & validation: initial documentation / IQ-OQ-PQ.

12. Summary

HESTA designs and manufactures medical refrigerators and warmers for healthcare, laboratories and pharma logistics. We provide temperature stability, regulatory compliance and the full documentation required under GxP, along with support for qualification and validation.

We also adapt selected popular device models so they meet the performance expected of professional medical refrigerators and warmers.

Example models available from HESTA:

• Medical refrigerator 15 L (12 V / 230 V, battery)
• Medical refrigerator 27 L with heating
• Medical refrigerator 37 L
• Portable refrigerator 21 L
• Portable medical refrigerator 14 L