CordenPharma Caponago Inaugurates New Packaging Department

[Photo by CordenPharma] Syringes in our new blister packaging line at CordenPharma Caponago, IT.

A €6 Million investment to increase capacity & efficiency for customers

We are pleased to announce the inauguration of a new, centralized, automated packaging department at our CordenPharma Caponago site, located just outside of Milan, Italy. The expansion and upgrade increase the facility’s packaging capacity and efficiency to better serve current and future customers’ needs. With an investment of €6 Million, construction on the new building began in Aug 2021 and was completed in July 2023. The packaging area, with a total floor plan of more than 2150m² located on the ground floor of the new Lipid Nanoparticle (LNP) manufacturing building, is conveniently located next to the SAP-controlled warehouse and boasts 4 automatic filling lines and 2 semi-automatic filling lines.

Proper packaging is an essential element in the manufacture of an Injectable Drug Product

By preserving product integrity and pharmaceutical quality, while ensuring the safety of its administration to the patient, proper packaging plays a crucial role in the manufacture of an Injectable Drug Product.

CordenPharma Caponago manufactures sterile injectable products in primary packaging containers such vials, Pre-Filled Syringes (PFS) and ampoules. The next stage of the packaging process involves secondary packaging of these containers into boxes and cartons for shipment and distribution throughout the supply chain. For early clinical projects, the number of packages required is usually smaller, and therefore can be manually packed. For later stage and commercial products, the number of packages involved is much larger, requiring automated or semi-automated packaging.

The boxes and cartons are then labelled with information such as product name, serial number, storage condition, dosage strength and expiration dates, and may contain one or multiple units, sometimes with diluent and local language instructions on how the product should be used. Furthermore, with serialization and aggregation, traceability of the drug is ensured throughout the distribution chain.

Optimized layout of 6 packaging lines

The improved floor plan allows for a better process flow back and forth between the warehouse and the new packaging area, which includes 4 automatic lines for the high-speed packaging of PFS, vials and ampoules, and 2 semi-automatic packaging lines for different PFS and vial sizes. The speed of the lines varies depending on packaging configuration, and operates within a range of 3-300 units / min. A wide variety of primary packaging types and sizes can be packed in these lines, and further primary packaging types can be potentially accommodated with format changes followed by IQ/OQ (Installation Qualification and Operational Qualification).

[Photo by CordenPharma] New packaging area at CordenPharma Caponago, IT.

Full compliance with EU Falsified Medicines Directive (FMD) & US Drug Supply Chain Security Act (DSCSA)

The CordenPharma Caponago packaging department adheres to the latest industry standards of commercial packaging by applying serialization and aggregation to all packaged products – thereby ensuring even more patient safety. Serialization involves applying a unique identifier to each individual package, while aggregation involves applying a related unique identifier to the product’s corresponding pallet that may contain thousands of packages. The pallet can then be scanned by customers without being opened, allowing them to access information for each package including expiry date and lot numbers. Regulations such as the EU Falsified Medicines Directive (FMD) and the US Drug Supply Chain Security Act (DSCSA) were brought into existence to increase patient safety by reducing the risk of patient exposure to counterfeit or falsified medicines.

[Photo by CordenPharma] The Packaging Team at CordenPharma Caponago, IT.