Skyepharma adds high-speed blister packaging to CDMO offer

Saint-Quentin-Fallavier, France: – Oral dosage specialist Skyepharma Productions S.A.S. (Skyepharma) has added new highly-automated blister packaging lines to its advanced manufacturing site near Lyon.

The new bottle and blister packaging lines, including serialisation and aggregation, have enabled Skyepharma to add fully-integrated packaging to its full service CDMO offer.

Whole range packaging

The new blister packaging line can handle all formats, including all materials as PVC, PVDC, ACLAR, TRIPLEX with aluminum foil or ALU/ALU. The blister line, located in an Iso 8 dedicated primary packaging section, is able to handle all kind of tablets and capsules.

The secondary packaging section includes horizontal cartoner, a checkweigher, a Track & Trace printer and automatic casepacker with aggregation.

Investment program

The new lines are the end products of a five million euro investment project that began in 2018, aimed at equipping Skyepharma with advanced packaging capabilities as part of its overall strategy to transform itself into an end-to-end CDMO, providing full services, from early stage development through to commercial manufacturing and packaging.

Having added a bottle packaging line last year, Skyepharma has started a second packaging line dedicated to advanced blister packaging.

Serialization

The project became ever more complex, reflecting fast-evolving pharmaceutical regulatory requirements, particularly in serialization and aggregation.

A bottle packaging line added early in 2018 including automated counting, weighing and filling of pill boxes that are themselves packed into cartons. These packages can be serialized for individual identification to meet recent North American market serialization standards introduced in November 2017 and EU guidelines effective from February 2019.

Aggregation

Beyond serialization, the packaging line took on a whole new dimension from November 2018 when Skyepharma decided to add aggregation capabilities in anticipation of future American, EU and Russian standards.

Currently in the United States, drug boxes must be serialized and grouped into serialized cases. From November 2023, these two levels of serialization will have to be combined by parent-child links.

“It is about more than a regulatory requirement,” says Skyepharma engineering manager Sébastien Le Gouil, in charge of setting up the new blister packaging line.

“Aggregation allows flexibility for the supply chain, allowing, for example, specific units to be picked from pallet,” Le Gouil explains.

Individual commissioning/decommissioning

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

For serialization and aggregation, Skyepharma chose Marchesini group with Sea Vision for inspections hardware and software. This solution offers simplified automated reprocessing operations that closely integrate packaging machinery with vision checking systems. Unusually, the Marchesini-Sea Vision combination operates autonomously without requiring connection to a line server. Unique numbers are integrated at the beginning of a batch, rather than during production, 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.

In addition, to minimize print-related waste, the solution uses a cleat conveyor that keeps the printing surface perfectly flat, unlike a belt conveyor that squeezes the carton and bulges its printing surface.

About Skyepharma Production

Skyepharma Production S.A.S. (Skyepharma) is a specialist CDMO with particular expertise and capabilities in oral solid dosage forms, being a key player in drug development and delivery of oral technologies serving the global pharmaceutical, biotech and consumer health industries.

Skyepharma is the oral business unit of the Vectura Group of companies, an international leader in inhalation and other drug delivery forms.

As an integrated CDMO, the company’s vision is to help solve healthcare industry complexity with a mission to provide a dedicated and results-oriented team to deliver advanced oral dosage services to the healthcare industry through state-of-the-art facilities, scientific expertise and open, transparent relationships. All of this is summed up in its strapline: ‘Expert and Agile CDMO partner for tailor-made solutions’.

The Skyepharma CDMO offer in solid oral dosage formats encompasses the whole value chain, including Formulation Development & Process Design, Analytical Development, Scale-up, Manufacturing, Packaging, Serialization and Aggregation.

Skyepharma also provides a range of support services that help client companies from early stage development (up to phase III), through scale-up and full commercial manufacturing and packaging to market introduction, including controlled substance handling, QbD methodology (FMEA, FTA, DOE), Troubleshooting, regulatory services, validation, registration and warehousing services.

Resources

Click on High speed blister packaging to see video of new line in action.