In the pharmaceutical industry, temperature control is not simply a matter of operational preference — it is a regulatory requirement and a matter of patient safety. The EU guidelines on Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) set out precise requirements that also apply to rented refrigeration systems.
This article explains the regulatory requirements that pharmaceutical companies impose on refrigeration systems, which temperature zones are relevant, and how SOS-Rentals provides GMP-compliant rental solutions.
| Here’s what you can expect from this article: |
| ✔ EU GMP and GDP: What these guidelines mean for refrigeration systems |
| ✔ Temperature zones in the pharmaceutical industry — from +25°C to −86°C |
| ✔ Qualification requirements (IQ/OQ/PQ) for hired equipment |
| ✔ Typical use cases in the pharmaceutical and biotech sectors |
| ✔ What SOS-Rentals provides — and what pharmaceutical companies need to do themselves |
| ✔ FAQs on GMP-compliant rental cooling |
Regulatory framework: EU GMP, GDP and ICH
Which EU directives govern the refrigeration of medicines?
The key regulations governing pharmaceutical refrigeration: EU GMP Annex 1 (2022, sterile products), EU GDP Guidelines 2013/C 343/01 (storage and distribution), ICH Q1A(R2) (stability testing, storage temperatures) and WHO Technical Report Series 961 (Annex 9, international guidelines) . Rental refrigeration systems must be capable of being integrated into the facility’s qualification system.
| Regulation | Relevance to cooling |
| EU GMP Annex 1 (2022) | Governs the manufacture of sterile products. Regulations on environmental control, including temperature. Applies to all production rooms and storage areas. |
| EU GDP Guidelines 2013 | Guidelines for wholesale and distribution. Temperature monitoring, qualification of warehouses and vehicles, deviation management. |
| ICH Q1A(R2) | International: Stability test conditions are defined by storage temperatures (25°C/60% RH, 30°C/65% RH, 40°C/75% RH). |
| WHO TRS 961 Annex 9 | International WHO guidelines on Good Distribution Practice (GDP). The basis for many export markets outside the EU. |
| 21 CFR Part 211 (FDA) | US GMP requirements — relevant to pharmaceutical companies with FDA authorisation or those exporting to the US. |
Temperature zones in the pharmaceutical industry
The EU Pharmacopoeia and ICH guidelines define five main temperature zones: ≤+25°C (room temperature, Zone II), +2°C to +8°C (fridge temperature), −15°C to −25°C (deep-freeze), −60°C to −80°C (ultra-low temperature, e.g. mRNA vaccines) and −196°C (cryostorage, liquid nitrogen — not covered by rental refrigeration).
The 5 pharmaceutical temperature zones
| Temperatur zone | Area | Typical products | SOS Rentals Annex |
| Room temperature (Zone II) | +15°C to +25°C | Tablets, capsules, solids | Air conditioning |
| Fridge temperature | +2°C to +8°C | Biologics, vaccines, insulins | Refrigerated containers/air chillers |
| Low temperature | −15°C to −25°C | Plasma, tissues, certain biologics | Cryogenic plant |
| Ultra-low (ULT) | −40°C to −86°C | mRNA vaccines, cell banks | Ultra-low temperature down to -86°C |
Qualification requirements: IQ, OQ, PQ for hired equipment
Do rental refrigeration systems in the pharmaceutical industry need to be qualified?
Yes. In accordance with EU GMP Annex 15, all systems that affect product quality — including temporary hire equipment — must be qualified. This typically includes installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ). Upon request, SOS-Rentals provides all technical documentation for the IQ; the OQ and PQ are the responsibility of the pharmaceutical company.
| Qualification level | Division of responsibilities between SOS-Rentals and the pharmaceutical company |
| IQ (Installation Qualification) | Where required, SOS-Rentals provides: technical specifications, calibration certificates, installation drawings and F-gas documentation. The IQ is carried out by the pharmaceutical company or its appointed QA team. |
| OQ (Operational Qualification) | Evidence that the system operates within the defined operating limits (temperature range, alarm test log). This is the responsibility of the pharmaceutical company. |
| PQ (Performance Qualification) | Verification of uniform temperature distribution in the cold store/process area under real-world conditions (mapping study). Carried out by the pharmaceutical company or a service provider. |
Typical application scenarios in the pharmaceutical and biotech industries
1. Temporary solution in the event of a system failure or maintenance
If a GMP-qualified refrigeration system breaks down or is shut down for maintenance, the cooling of the products must be maintained without interruption. Rental refrigeration from SOS-Rentals bridges this gap — complete with the technical documentation required to enable rapid emergency qualification.
2. Clinical trials and investigational medicinal products
Clinical trials often require specific cooling conditions for a defined trial period (e.g. −20°C for investigational medicinal products). Renting refrigeration is the most cost-effective solution in this case — the cooling requirement ends when the trial does.
3. mRNA and ultra-low temperature storage (−40°C to −86°C)
mRNA vaccines and advanced biologics require ultra-low-temperature storage. SOS-Rentals is one of the few rental providers in the German-speaking world to have ultra-low-temperature units capable of reaching −86°C in its rental fleet. Ideal for pharmaceutical companies that need to temporarily set up or expand their ultra-low-temperature storage capacity.
4. Product scale-up and production expansion
When a pharmaceutical product reaches market readiness and production is ramped up, there is often a short-term shortage of refrigeration capacity. Rental refrigeration bridges the gap until the permanent solution is installed — without interrupting ongoing operations.
What SOS-Rentals offers pharmaceutical clients
Technical documentation and documents from SOS-Rentals: |
✔ Technical specifications of the plant (for IQ documentation) |
✔ Calibration certificates on request (traceable to PTB/DIN EN ISO 17025) |
✔ F-gas certificate in accordance with EU Regulation 2024/573 |
✔ Type of refrigerant and GWP value (relevant for environmental documentation) |
✔ Commissioning report showing actual temperatures |
✔ On request: alarm thresholds and test report template for OQ |
FAQ: Rental cooling in the pharmaceutical industry
Can a rental facility be GMP-certified?
Yes. Rental systems can be qualified — the process is identical to that for qualifying fixed installations. SOS-Rentals provides all the technical documentation required for IQ documentation. OQ and PQ are carried out by the pharmaceutical company or a contracted qualification service provider.
What rental equipment does SOS-Rentals offer for mRNA vaccines and ultra-low temperature applications?
SOS-Rentals offers ultra-low temperature storage systems down to −86°C. These are suitable for mRNA vaccines, cell banks and other ULT applications. The specific system will be selected according to your specifications — please contact us for a bespoke quote.
How is temperature monitoring ensured in rented facilities?
SOS Rentals systems feature internal temperature recording. For GMP-compliant, 21 CFR 11-compatible data logger systems, we recommend the use of an external, validated monitoring system — this is the responsibility of the pharmaceutical company.
Can pharmaceutical companies demonstrate that they have a leased facility as part of a GDP inspection?
Yes — provided the system has been properly integrated into the QMS and validated. SOS-Rentals provides all the necessary technical documentation relevant to a GDP inspection.
Conclusion: GMP-compliant rental cooling — flexible, verifiable, available at short notice
The pharmaceutical industry places the highest demands on refrigeration systems. SOS-Rentals’ rental refrigeration units meet the necessary standards, can be delivered at very short notice provided they are in stock, and offer temperature ranges from +15°C to −86°C. SOS-Rentals is the partner of choice for pharmaceutical companies requiring GMP-compliant refrigeration capacity at short notice, for specific projects or in emergencies.
Enquire about GMP-compliant pharmaceutical refrigeration
Technical documentation available on request · Temperatures down to -86°C · Immediate response time
☎ +49 2935 / 9690 370 | info@sos-rentals.de | sos-rentals.com/contact
