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Pharmaceutical Technology TRENDS IN MANUFACTURING 2022 eBOOK 27 drying cycle and potentially reduce additional time that is routinely used to ensure sufficient water removal • Use of parenteral packaging that reduces the likelihood of vial breakage, which could re- sult in a high loss of drug product, during the lyophilization process. Such parenteral pack- aging includes certain glass types used in vials (e.g., Valor Glass, Corning) that are treated in such a way as to enhance the pro- tective properties of the glass (e.g., in the case of Valor Glass, the glass is ion-exchanged and externally coated, which provides up to 10x the strength of conventional glass vials). Product quality is inf luenced by a number of factors, including the primary packaging compo- nents. Externally coated glass vials can improve quality by reducing the generation of glass par- ticulate that can contaminate the product and the introduction of glass damage that can create cosmetic defects, which make vials more suscep- tible to breaking during the freeze-drying pro- cess. "Consistent vial geometry can also improve product quality by reducing the variability of the vial-heat-transfer-coefficient and its subsequent impact on the drying rate of product within a given vial," says Hall. Another approach that companies are taking to address the challenge of product stability and cold- chain management for biotherapeutics is by devel- oping a lyophilized dosage form for that product. "The benefit of a lyophilized dosage form is to in- crease product stability at preferred storage condi- tions; for example, developing a lyophilized dosage form with refrigerated or ambient [temperature] for a liquid formulation, where previously -20 °C or -80 °C storage was required," says Bourassa. "A lyophilized product can dramatically reduce the product's carbon footprint and the overall cost of cold chain management for parenteral products due to the lower shipping weight and ambient ship- ping temperatures," Bourassa adds. Meanwhile, newer refrigeration systems are de- signed to be particularly energy efficient. These new systems (such as those designed by Optima) achieve the defined temperatures in the ice con- denser and set-up areas with extreme precision, emphasizes Rosenbaum. "With the F-Gas regula- tion [European Union Fluorinated Greenhouse Gases Regulation (1)] in Europe, for example, new framework conditions apply to the design of freeze-drying plants in regard to the refrigera- tion technology. Different solutions are possible to reach the required temperatures of approximately -100 °F/-70 °C at the ice-condenser and -60 °F/-50 °C on the shelves," Rosenbaum explains. The solutions being referred to earlier include LN2 refrigerant, which is a technically proven solu- tion that has been known for years and is future- proof in terms of the F-gas Regulation, according to Rosenbaum. He explains that the investment costs in relation to the refrigeration system are lower here compared to the following solutions, but the con- sumption costs increase the more often the system is used. "This means that freeze-drying plants with LN2 refrigerants must be adapted to meet the opera- tor's operating scenario. This solution is suitable for new projects. However, with minimal effort, exist- ing plants for climate-damaging refrigerants could also be converted to an LN2 system," he states. Meanwhile, for the use of refrigerants that are ex- pected to be available in the medium term, such as R410A, and refrigerants available in the longer term, such as R448A, both refrigerants are non-flammable,