PAS-X role in Genzyme paperless manufacturing

Genzyme, a leading biotechnology company, has deployed the Manufacturing Executions System PAS-X from the software specialist Werum Software and Systems at their production site in Waterford, Ireland

The Genzyme Waterford manufacturing facility is, amongst others, the primary tabletting and bottling centre for the successful kidney dialysis drug Renagel.

Genzyme has a total of seven manufacturing sites in Europe.

Its Waterford plant serves as its major European production and distribution centre for large volume runs of its range of products.

Genzyme has made its Waterford site a state-of-the-art manufacturing facility which sets new standards of excellence in quality, compliance and efficiency.

The implementation of an MES has been an essential step towards reaching this status.

Werum PAS-X significantly drives the Genzyme right-first-time and real-time-release strategy in manufacturing by introducing paperless electronic batch recording.

PAS-X is a standard off-the-shelf product specifically designed for the pharmaceutical and biopharmaceutical industries.

It helps in streamlining manufacturing processes, improving product quality, decreasing product cycle times, increasing equipment efficiency and assuring compliance within GMP and FDA-regulated production and packaging environments.

The Genzyme use of the software modules from the PAS-X portfolio enables the coverage of a broad spectrum of functionality.

The core functions include recipe creation (MBR), weighing (WD), electronic batch recording (EBR), warehouse management (WMS), material tracking (MT), and deviation management (DM).

The MES system is a central building block in the IT infrastructure of the facility and links the enterprise administration with the equipment level.

PAS-X exchanges data with the business level through an ERP interface and also integrates the shop floor equipment.

The development of the Genzyme facility in Waterford started three years ago with the transformation of a 12,500 m2 building into a state-of-the-art pharmaceutical facility.

The facility has an annual capacity to produce and pack 800 batches.

In parallel with the implementation, Genzyme has started to build a further expansion of the pharmaceutical site.

The Renal Expansion building is occupying 7,500 m2 and will provide Genzyme Waterford with a 100% increase in tabletting capacity by implementing the latest state of the art tablet manufacturing process.

One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases.

Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 9,000 employees in locations spanning the globe and 2006 revenues of $3.2 billion.

With many established products and services helping patients in nearly 90 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences.

The company's products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant, and diagnostic testing.

The Genzyme commitment to innovation continues today with a substantial development programme focused on these fields, as well as immune disease, infectious disease, and other areas of unmet medical need.

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