Cold Chain
Warehouse space and refrigeration equipment for storage and servicing of medical immunobiological products
Cold Chain Logistics
The Group offers customers warehouse space and refrigeration equipment designed and equipped for storage and handling of medical immunobiological products.
It is known that vaccines can lose their immunogenic activity over time, due to exposure to heat or hypothermia. Maintaining the correct temperature regime during the vaccines storage and transportation is a critical task for preserving the product activity and the vaccination effect.
Our warehouses operate a system that ensures optimal conditions for storing and preparing heat-labile products for handling.
The cold chain regime is ensured in the system of integrating proper actions of personnel, competent equipment use and regular implementation of control procedures.
Our warehouses operate a system that ensures optimal conditions for storing and preparing heat-labile products for handling.
The cold chain regime is ensured in the system of integrating proper actions of personnel, competent equipment use and regular implementation of control procedures.
Warehouse handling of ‘cold chain’ products
Warehouse handling of cold chain products includes the following procedures:
We highlight a number of basic requirements for personnel:
- goods receipt;
- proper storage organization;
- products orders and product dispatch.
We highlight a number of basic requirements for personnel:
- We assign responsible persons by internal regulations and orders;
- We conduct mandatory training for the personnel working with ‘cold chain’ products;
- We record the actions performed;
- We issue accompanying documents for dispatched products indicating the products in the ‘cold chain’.
The handling of products at the storage and warehouse processing stages is organized in accordance with Standard Operating Procedures (SOPs)
At the acceptance stage:
At the storage stage:
Operations for order fulfilment and dispatch:
- SOP for monitoring transportation conditions;
- SOP for handling depending on the means of transportation: refrigerators, thermal containers;
- SOP for the procedure for medicines receipt and implementing receipt control;
- The procedure for monitoring the condition of the vehicle (with readings from temperature recorders) is drawn up by the responsible person in an internal report. The time frame for unloading is registered by the responsible person in the internal report.
At the storage stage:
- SOP for the procedure for storing medicines, including those requiring special storage conditions;
- SOP of the personnel action procedure when the temperature and humidity parameters of the production premises of the warehouse reach the "alarm level" and "action level":
- SOP in case of emergency, power outage, refrigeration chambers breakdown.
- At the dispatch stage:
- SOP of the procedure for collecting and assembling medicines;
- SOP of monitoring transportation conditions.
Operations for order fulfilment and dispatch:
- Order picking is performed directly in the refrigeration chamber;
- Packing in thermal containers;
- Laying out cooling elements;
- Installing temperature data loggers;
- Checking the refrigerator readiness;
- Fulfilling loading time frames.
Equipment
Warehouses and refrigeration chambers are equipped with a climate monitoring system that allows for constant monitoring of storage conditions, including temperature and humidity.
The refrigeration chambers have zones for receiving and assembling heat-labile medicines.
The refrigeration chambers are equipped with:
The refrigeration chambers have zones for receiving and assembling heat-labile medicines.
The refrigeration chambers are equipped with:
- spare refrigeration units;
- separate gates for personnel and equipment;
- rack systems;
- an integrated control and automation system, alarm system;
- locks on the outside and unlocking on the inside;
- Testo Saveris control and measuring instruments (24/7);
- "Mirage" duplicate GSM notification system;
- notification is provided at the "alarm" and "action" levels.
Validation
The equipment used for storing immunobiological medicines and monitoring their storage conditions is validated.
Risk management
Each warehouse complex has implemented action plans and standardized procedures in the event of emergency situations:
- in case of emergencies;¶
- in case of power outages;¶
- in case of refrigeration unit malfunctions.¶
АО "САНТЭНС СЕРВИС" 2000-2025
