GM International’s new cold storage area has passed all operational tests.
Yesterday, November 2, 2026, we completed the thermal mapping process required by regulations, and we are now ready to receive our clients’ goods into the new +2°C/+8°C cold storage area.
We are very proud of this achievement, which marks the culmination of a journey that began several months ago, when we decided to expand the services offered to our clients by establishing a cold storage area within our warehouse.
It has been an engaging and demanding process, involving bureaucratic requirements, technical feasibility studies, health and hygiene regulations, skills development, and the upgrading of security systems. The storage of Active Pharmaceutical Ingredients (APIs) requires the utmost rigor in complying with all criteria set forth by general regulations, Good Distribution Practice (GDP) guidelines, oversight by the Italian Medicines Agency (AIFA), and authorizations issued by the relevant local health authorities (ATS/ASL).
The new cold storage area at the GM International warehouse—which complements our existing facility for temperature-controlled products—spans 150 square meters with a volume of 600 cubic meters. It utilizes a refrigeration system powered by R448A refrigerant gas, which is non-flammable, non-toxic, and has a low environmental impact.
The energy required to maintain the cold storage area is partlycovered by the photovoltaic system installed on the roof of the GM International warehouse. To this end, the system—in place since 2023—has been upgraded and now consists of 223 modules (460 Wp each), providing a total capacity of 160.00 kWp. To ensure that the temperature remains consistently between +2°C and +8°C
On May 20th we installed a state-of-the-art ELCOS POWER GENERATORS unit, which activates automatically in the event of a power outage.
On July 18th, we “activated” the cold storage area. Once the installation phase was complete, we carried out all the necessary tests and verifications.
Regarding the commissioning process, we underwent a validation procedure consisting of the following stages:
- IQ (Installation Qualification): Verification that the cold storage unit, solar panels, inverter, and generator are installed according to the project specifications.
- OQ (Operational Qualification): Verification that the cold storage unit and backup systems are functioning correctly.
- PQ (Performance Qualification): Verification that the cold storage unit maintains the correct temperature over time.
Regarding thermal mapping, we demonstrated compliance with WHO/GDP guidelines:
- The new cold storage area is equipped with a system of sensors connected to data management software validated according to pharmaceutical industry standards—capable of tracking access and parameter fluctuations.
- Simulations were conducted to demonstrate that the unit maintains a temperature range of +2°C to +8°C, both under extreme summer conditions (+40°C external temperature—maximum load) and during cold winter temperatures.
- “Open-door” tests were performed to determine how many minutes the door can remain open during loading operations before the temperature exceeds +8°C.
- Autonomy tests during a power outage were also conducted to verify the activation of the backup generator and the transmission of alarm signals to the personnel responsible for safety and security.
We are therefore equipped to handle products, that require storage within this temperature range—such as pharmaceuticals and biotechnological products, including insulin, vaccines, complex biological drugs, blood derivatives, antibiotics, and liquid-form hormones—for which a temperature fluctuation could negate a drug’s efficacy or even render it toxic.
Storage and preservation temperatures between +2°C and +8°C are also required for many chemical products and laboratory reagents, as well as for certain professional cosmetic products—typically those free from preservatives or containing probiotics or other ingredients susceptible to oxidation and rancidity.