Skyepharma set-up for serialization and aggregation, ready for Russian market

Since 2018, oral dosage CDMO Skyepharma radically updated and expanded its packaging capabilities, opening new packaging lines equipped for serialization and aggregation.

Contract services – packaging capacities

The development of Skyepharma packaging capacities is part of its overall strategy to transform itself into a fully-integrated CDMO since 2016, providing full services, from early stage development through to commercial manufacturing and packaging, allowing its customers to have a single point of contact at each steps of their project.

In line with this strategy, Skyepharma, known for its expertise in development and manufacturing of classic and complex oral dosage forms (single-layer tablets, multi-layer tablets, tab-in-tab, tab in caps) acquired two brand new packaging lines for blister and bottle. The company also made the choice to equipped both lines with serialization and aggregation then anticipating future client needs in line with markets regulations.

The bottle line is running commercially since 2018. Following the same example, the blister line was installed in February 2019 and is running commercially since June. This is the result of effective teamwork and anticipated training on both lines, which allowed to accelerate their speed of implementation.

Bottle & blister primary packaging

Skyepharma chose to work in partnership with the Italian manufacturer Marchesini for its packaging lines. The bottling line is able to fill any type of bottle (round or squared, plastic or glass) with tablets and capsules; and the blister line is able to fill any kind of tablets and capsules, in all types of blisters (PVC, PVDC, aclar, triplex, alu/alu).

Capacity of the bottling line
• Up to 75 bottles/min
• Bottle width 18 to 90 mm
• Caps’s width 7 to 50 mm
• Bottle height 35 to 180 mm

Capacity of the blister line
• Up to 210 blisters and cartons/min.
• Blister length 70 to 140 mm
• Blister width 30 to 86 mm
• Depth Up to 12 mm

Located in an Iso 8 dedicated primary packaging section the lines have been designed to be as flexible as possible to meet the maximum potential needs of customers.

The bottle line has a counting station to weigh the bottles before and after filling; and a visual counting station of tablets/capsules, with four control cameras. Implementing such an online double control system is an industry first, thus guaranteeing both the integrity and the quantity of the tablets or capsules processed.

Secondary packaging – serialization and aggregation

Secondary packaging of both lines is equipped for serialization and aggregation. Carton packages are marked with a 2D datamatrix to identify them individually, in accordance with the serialization standards required in the United States, European, Russian and Saudi Arabian markets. With the aggregation solution, the numbered cartons are linked to the case and finally to the pallets by parent-child links. Aggregation allows flexibility for the supply chain, allowing, for example, specific units to be picked from pallet.

Skyepharma chose Sea Vision for the management of serialization and aggregation data. Unique numbers are created, which means each package can be individually decommissioned from a batch if rejected. In this case, the serialization number will automatically be designated as invalid – preventing any recovery for fraudulent use.

The new lines now meet all current and pending serialization and aggregation standards, including FDA, EMA, ANVISA and Korean FDA.