Our expertise in production sites to guarantee the quality of active vaccine ingredients storage.
CSV Life Science validation team, represented by its division Pharma Hub, has been working for years with major pharmaceutical sites in Lazio, the beating heart of our country’s production. This region is indeed playing an important role in the fight against COVID-19 and the new players taking over the management of some important pharmaceutical plants have entrusted our group to help them defeating this virus. Since the beginning of the year, work has intensified in some of these plants, to prepare part of the production of the next vaccine that may be approved by the EMEA, which is already being administered in some parts of the world, primarily in England.
Ultra-low temperature freezers.
Our Validation Coordinator, Giuseppe Passero, for a couple of months has been working with his colleagues on the validation of ultra-low temperature freezers that will guarantee the correct storage of the active vaccine ingredients.
The cold chain.
This is an essential work to ensure the quality and stability of the well-known cold chain, which is proving to be difficult, especially for the first two RNA-based vaccines on the market. In this case, however, the validation process concerns the production chain and the need to keep the active ingredients at very low temperatures; after bottling operations, the storage conditions will no longer be as extreme, as the manufacturer promises.
These vaccines nucleus is therefore stored in special freezers capable of reaching temperatures as low as -80° before being thawed and processed to make the finished product. It is therefore essential that the product is stored at a temperature that does not compromise its quality in any way.
Our operators are busy mapping the refrigeration devices using low temperature probes. The data are collected for a few days and then processed to assess whether the temperature remains constant over time and is as uniform as possible within the freezer. Another significant piece of data is the recovery time it takes for the temperature to return to the set working values once the product load is placed in the cooler.