Pharmaceutical and biopharmaceutical processes often require very strict temperature control during their different stages. The production chain for biological medicinal products usually requires a cold chain between 2°C and 8°C. However, the range may vary depending on the product.
The maintenance of the cold chain is required in all stages of the production process: from raw material reception, production activities and storage, to distribution.
Obviously, the cold chain is another fundamental element that we have to take into account in all our projects. Especially when it comes to HVAC and air conditioning.
The ultimate goal of the design is to maintain the cold chain necessary for the preservation of the product during all stages of the process. Breaking the cold chain could compromise the quality of the product. And even, in some cases, force the discarding of a batch. It is therefore a vitally important element for laboratories.
The key to good cold chain design: process knowledge
Knowledge of the production process is key to design. By understanding these needs, we can propose solutions that fit each plant:
- Production stages and product needs during each one of them
- Temperature difference between the temperature of the product entering the room and the temperature that needs to be obtained inside.
- The volume of product to be moved or stored at each stage to define the required circulation and storage size.
- Loading and operational formats of the logistics in the plant.
- Planning and temperature control of the product during these stages. With systems for temperature verification and documenting times via a monitoring system.
Some of these points may be difficult to determine or unknown to some of our customers – especially in cases where the product is new. In these cases, our process, HVAC or logistics experts can help give estimates based on their experience.
Necessary points for the design of the cold rooms:
With the needs of the process defined, we can design the plant’s cold rooms. The points to be studied are common to the design of most warehouses, although in the case of refrigerated warehouses their impact is greater due to the energy cost involved. The points to be studied are:
- Specific heat of the product
- Number of daily door openings
- Air renewal requirements
- Classification of the room (if it is a classified room)
- Considerable internal loads due to machinery or occupancy
With all these inputs, each case is studied to see, according to the necessary power, the requirements of the installation, the need for redundancy, technology and the most recommendable refrigerants that fit in with the ecological and thermal efficiency objectives.
In this regard, we would like to emphasise that the cooling of the rooms has a great impact on the energy consumption of the plant. Therefore, the chosen solution will be very important to reduce the carbon footprint of the production as well as the costs.
Conclusion
The design of the cold chain must take into account several aspects of the plant. Especially the process. The chosen solution will have a major impact, not only on the quality and safety of the product, but also on the operational costs of the plant and its environmental impact.
To achieve this, the project team will have to rely on experts in product, pharmaceutical processing, air conditioning and logistics, as well as the involvement of industrial refrigeration and control suppliers. The Klinea team has been designing plants for the pharmaceutical sector for more than 20 years and can give you all the support you need so that your cold chain is fully optimised. If you want to know more about the cold chain and how we can help you, contact us: klinea@klinea.eu
