PharmaIndustrial India Magazine September-October 2023

Engineering the Chill: Building Effective Cold Chain Systems for Pharmaceutical Manufacturing Pharmaceutical and biopharmaceutical processes often re- quire very strict temperature control during their different stag- es. 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, produc- tion 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 stag- es 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 prod- uct 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 docu - menting 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 prod- uct is new. In these cases, our process, HVAC or logistics ex- perts can help give estimates based on their experience. Joan Cano Cervelló Speciality Lead Process & Utilities Klinea ANRETWICSLE PHARMA INDUSTRIALINDIA · SEP-OCT 23 24