With an estimated value of $1.1 trillion, the pharmaceuticals industry is expected grow to by 41% over the next three years. The introduction of biosimilars and a high demand for biologics, such as insulin products and vaccines, are among some of the factors that are influencing the sector's phenomenal growth. Some pharmaceutical manufacturers want a stake in the attractive biopharmaceutical market and must earn their place by developing a reliable validation master plan (VMP) in order to ensure that products arrive safely and promptly to global patients.
There are many important factors to consider when designing a thermal-packaging solution that delivers products safely, including cost and performance. Carefully examining and testing a solution guarantees that it will meet the requirements of a company and its desired product.
Understanding the capability of a storage site is essential with regard to capacity, refrigerant conditioning and the storage of materials. For a larger company that may experience a lot of traffic at its site, it is imperative to ensure that freezers are not only available, but are also able to house a large quantity of products. A significant amount of space and energy is required, so it is vital that companies carefully consider whether to freeze a few refrigerants, several cases of product or pallet loads. A site's overall capability can be determined by completing a preconditioning study and comparing the lead time needed with ongoing demand.
Two kinds of pack-outs are used for the management of temperature-sensitive products: seasonal pack-outs, and universal pack-outs. The first is a configuration of refrigerants in a shipping system that is based on predefined temperatures that will be used during transportation. They reduce cost, but these pack-outs do not protect against unexpected temperature fluctuations. Universal pack-outs use standardised systems to maintain consistency throughout the packing process and temperature conditioning.
There are several ways to minimise pack-out errors, regardless of the type that is chosen. It is imperative that the distribution team's feedback is collected during the design process, as this takes usability, ergonomics and safety into account. Once a design is complete, companies must train staff in the visual aids, instructions and components that they will come across during the pack-out process. This hands-on approach is the best way to ensure that staff members understand procedures, critical-to-quality variables in the design and their own role in executing the validation plan.
Once they have been packed, procedures must be in place for handling thermal packages while they are waiting for carriers to arrive. It is important that companies understand their carrier's network, taking their capabilities and storage parameters into account. These factors must be considered when designing the qualification process and VMP.
For any new thermal-packaging system, it is also best practice to validate its performance with thermal modelling. This enables companies to assess its capabilities should new distribution lanes be added, or extra medication shipped or changes be made to existing routes or carriers.
Data collection supports everything that pharmaceutical companies do in relation to preparing materials, handling packages, pack-out configuration and carrier procedures, as well as creating standard operating procedures and training records. These factors verify that companies are following guidelines that compile a strong validation master data package. This can then be handed off to any affiliate globally, and it can implement the same solution and achieve the same results. Existing procedures can now be assessed for continuous improvement in performance and operations.