Cold chain steps
Cold chain steps are aimed at due handling of the medicinal drugs, vaccines, and biological materials requiring temperature mode.
Essential of the cold chain is development and treatment of the temperature control and maintenance system and other critical storage and shipment conditions.
Why is this needed? To ensure unaffected quality, composition and attributes of the biological materials within the whole door-to-door way.
Why standards are crucial and what is the point
Most of the above mentioned drugs retain their properties under special conditions only. If the vaccine is overheated, it loses its attributes, and this is an irreversible.
Storage and transportation conditions differ for different types of biomaterials. For most vaccines, the optimal temperature range is +2 to +8 C. Some require freezing for long-term storage, and there are components for which negative temperatures are unacceptable, e.g., adsorbed drugs.
The following vaccines are sensitive to temperature regimen: vaccines against measles, poliomyelitis, diphtheria tetanus vaccine, vaccine of Calmette and Guerin, Diphtheria and Tetanus Toxoids and Pertussis Vaccine against hepatitis B, or against whooping cough.
Cold chain proper functioning
For the chain to work properly, the following processes are to be duly streamlined
1. Special equipment available and is maintained properly. Alternative options for emergency are to be developed.
2. Special training of personnel monitoring equipment and materials.
3. Compliance with all the regulations and rules for vaccines’ and biomaterials’ storage and movement of.
4. Control system, including technical solutions, temperature maintenance throughout the door-to-door delivery.
Cold chain stages
4 stages are pointed out.
- Stage 1 includes the following: storage and delivery of medical IMP by manufacturers to pharmacy depots (see Storage and warehouse services).
- Stage 2 regulates storage and delivery from pharmacy depots and State Sanitary and Epidemiological Supervision depots to regional and city depots for storage.
- Stage 3 - second-level parties’ delivery to regional pharmacies and health care organizations, i.e., delivery to district and rural pharmacy depots or to hospitals and clinics.
- Stage 4 is performed within rural healthcare institutions and organizations. The stage includes storage and movement of drugs inside hospitals or clinics.
Which documents are regulatory in the field?
On 17 Feb 2016 Sanitary rules СП 3.3.2.3332—16 were approved. These regulate Conditions of delivery and storage of the IMP. Full text of the document is published on the Rospotrebnadzor website. This document is basic for the Cold Chain design and working with immunobiological drugs.
In General, the field is regulated by the Federal Law “Concerning the Immunoprophylaxis of Infectious Diseases”