Santens

Cold Chain

Cold chain logistics
Cold Chain
The Group offers warehouse premises and refrigerating equipment designed and fitted out for storage and maintenance of immunobiological medical products.
Vaccines can lose their immunogenic activity over time, especially as a result of exposure to heat or freezing. Ensuring that the optimal temperature is maintained during the storage and transportation of vaccines is critical for preserving the activity of the vaccine and the effect of vaccination.
Our warehouses have a system to ensure that thermolabile products are stored and prepared for circulation in optimal conditions.

The cold chain regime is ensured as a system integrating proper actions of the employees, competent exploitation of equipment and regular control procedures.
Warehouse processing of cold chain products
Warehouse processing of cold chain products includes the following procedures:
  • acceptance;
  • arrangement of proper storage;
  • order picking and product dispatching.
The cold chain system at our warehouses was implemented using modern equipment and is controlled by the QA department.

We identify certain basic requirements for our employees:
  • We appoint responsible employees by internal orders;
  • We provide mandatory training for employees working with "cold chain" products;
  • We log all operations performed by such employees;
  • We issue accompanying documents for dispatched products with the indication of all products that require "cold chain" conditions.
During the storage and warehouse processing stages, products are handled according to applicable standard operating procedures (SOP)
At the acceptance stage:
  • SOP for transportation conditions monitoring;
  • SOP for handling products depending on the method of transportation: refrigerators, thermal containers;
  • SOP for acceptance of pharmaceutical products and acceptance inspection;
  • The procedure for inspection of the condition of the transport vehicle (with checking logs of the temperature recorders) — is documented by an internal act issued by the responsible person. The responsible person records the duration of the unloading in the internal act.
At the storage stage:
  • SOP for storage of pharmaceutical products, including products requiring special storage conditions;
  • SOP defining actions of the employees in situations where the temperature and/or the humidity in the warehouse premises reach the "alarm level" and the "action level":
  • SOP for actions in emergency situations, blackouts or failures of refrigerating equipment.
At the dispatching stage:
  • SOP for picking and batching pharmaceutical products;
  • SOP for transportation conditions monitoring.
Order picking and dispatching operations:
  • orders are picked directly in a cold room;
  • packaging in thermal containers;
  • placement of ice packs;
  • installation of temperature recorders;
  • verification that the refrigerator is ready;
  • compliance with the maximum allowed loading time.
Equipment
The warehouses and the cold rooms have climate control systems to ensure continuous monitoring of storage conditions, including temperature and humidity.

The cold rooms have zones for acceptance and picking of thermolabile pharmaceutical products.

Cold rooms are equipped with:
  • standby refrigerating units;
  • separate gates for employees and vehicles;
  • racking systems;
  • built-in automated control and alarm systems;
  • external locks and internal unlocking mechanisms;
  • testo Saveris instruments (operating 24/7);
  • backup Mirage GSM-band alerting system;
  • alerting can be done at the "alarm" level and at the "action" level.
Validation
All equipment used to organize storage of immunobiological pharmaceutical products and to monitor their storage conditions is validated.
Risk management
Each warehouse facility has implemented action plans and standardized procedures in case of the following emergencies:
  • emergency situations;
  • blackouts;
  • refrigerating unit failure;
The quality of such products directly depends on compliance with the temperature conditions specified by the manufacturers. Handling cold chain shipments and immunobiological pharmaceutical products, we strive to minimize the time such products spend outside the refrigeration equipment.
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