RoSS® Shell | Protecting single-use bags
The safest transport solution for all available single-use bioprocess containers. Robust. Scalable. Single-use bag independent.
March 14, 2023
Throughout the manufacturing process of drug substances, the liquids must be transferred frequently, such as during the upstream and downstream processing. Safe packaging of large volume substances is of high necessity in each step. Protection is ensured by appropriate primary and secondary packaging.
This article will provide an overview of the different types of primary and secondary packaging materials, which are used specifically for safe handling of drug substance. It will also cover the characteristics of single-use consumables as solutions for biopharmaceutical packaging.
Biopharmaceuticals are complex molecules that require specialized primary packaging to maintain their stability, sterility, and potency. Some challenges and risks associated with primary packaging for biopharmaceuticals include contamination, product degradation, and theft.
This case study illustrates the advantages in terms of cost-efficiency and reduced workforce through hybrid systems for protective single-use shell solutions around liquid transfers in biopharmaceutical processing.
The secondary packaging perfectly complements the internal primary packaging for maximum protection. It provides physical protection and barrier protection and often needs to guarantee regulatory compliance. All this in order to be able to transport the drug substances safely or to bring the final products to the patient.
Examples of secondary packaging include shells as a safe protection but also folding cartons, paperboard, trays, and film bundles. Secondary packaging can, but does not have to, play its role as the first packaging layer that consumers will see. In some cases, there is a tertiary packing, too.
It provides protection to the primary packages and products during distribution, display, and branding. It creates a separation that protects primary packaging components from one another and prevents products from mobilization during shipment.
Secondary packaging also plays a direct role in protecting the product and primary package from mistreatment or accidents by consumers. In addition, it provides ample space for branding, artwork, and regulatory information that is essential for product display and adherence to regulations.
Pharmaceutical packaging is crucial to ensure their safe storage and shipping. Biologics have specific regulatory requirements, defined by FDA, EMA, and ASTM D4169 for storage and transportation, starting with the correct packaging to enable efficient filling, freezing, and transportation.
Single Use Support offers end-to-end solutions to its customers in the biopharma industry, including fully automated platforms for filling and freezing, as well as consumables such as single-use bags, shells, and shippers for safe storing and shipping. With these solutions, biopharmaceutical products can be transported and stored safely and tamper-evident, while maintaining their quality and integrity.1