Time for radical change in the manufacture of pharmaceutical products

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Omron Industrial Automation is a leading manufacturer of technologically advanced industrial automation products and application expertise.

Facilities Consultant Rob Bowen presents consortium project on feasibility of continuous manufacturing for the global pharmaceutical industry

The last report from the seminars at the Total Processing & Packaging Exhibition 

 

Rob’s seminar focused on a consortium project led by GlaxoSmithKline (GSK) and partners GEA, Siemens, Sagentia and the Universities of Newcastle, Warwick and Surrey to prove the feasibility of continuous and closed manufacturing in the worldwide pharmaceutical industry.

The initiative was prompted by the removal of regulations that once prevented the introduction of continuous manufacturing.

The Problem

Up until now, pharmaceutical companies relied on batch manufacturing processes that were characterised by bulky inefficient equipment, low utilisation (30-40% average), low product yields, product non-conformance, high inventories, excessive warehouse capacity,high operating costs, slow changeover and long lead times due to stage and final product testing.

There was a reluctance to change regulator approved processes and any cycle time improvement was perceived to be limited by regulatory restraints.

Additionally, product quality was ascertained only in postproduction analysis, meaning that it could take as long as two months for a batch to be released.

Continuous Manufacturing

With continuous manufacturing, each tablet – not just each batch – comes with a complete set of production and quality information. The manufacturer can be sure that each individual product has exactly the required qualities, which means it can be released immediately after production.

The consortium worked together to bring about a radical change, seeking cutting edge solutions in a bid to significantly improve production processes and efficiencies.

The outcome is a fully integrated and closely controlled process that ensures consistency and reduces costs by 20 per cent, the process equipment footprint by a factor of ten and the capital cost by a factor of three.

Small, self-contained processes with a high level of automation and reduced manual intervention will enable companies to reduce variability, achieve 6 sigma, deliver high yields, increase profitability, offer flexibility for large and small quantities, pick up trends in seconds, facilitate rapid changeover (SMED) and fully automated CIP, and benefit from lower operating, inventory and capital costs.

Oral Solid Dosage (OSD)

For OSD, the project clearly demonstrated the feasibility and potential of continuous manufacturing units with real-time-release capability. It can significantly reduce process development times while also introducing a range of other benefits. End product testing alone is insufficient to understand the complex interaction of product and process.

Real-time product release, a long sought after capability, will soon become a feature of pharmaceutical manufacturing.

The Future

According to Rob, the pharmaceutical plant of the future will be a lean and agile facility with infrastructure, utilities and processing working in unison. It will have modular equipment designed for interchangeability, quick response to process demand and flexible cleaning. A new approach to supply chain will be implemented with supplier based quality control, flexible storage and automated dispensing. It must also be a sustainable flexible facility with modular servicing, multifunction capability, low carbon materials and natural resource re-use.

As a result of this GSK-led project, a fully continuous manufacturing line, which is an extremely complex process, can now be offered to pharmaceutical companies around the globe. In fact, many are currently leveraging the potential of continuous production and starting to introduce it into their facilities.

This consortium project received awards for ‘Outstanding Achievement in Chemical Engineering’ and ‘Chemical Engineering Project of the Year’ at IChemE 2012.

Omron

Omron offers a wide range of advanced automation technology for the modern pharmaceutical processing and packaging facility. Its market leading products are designed to minimise changeover and operator intervention. It remains committed to developing more energy efficient, multifunctional technologies to meet customer environmental targets. The company’s modular PLCs are backwards compatible and ideal for the changing pharmaceutical production process.

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Omron Europe

Omron Industrial Automation is a leading manufacturer of technologically advanced industrial automation products and application expertise. From its European headquarters in Hoofddorp, near Amsterdam in the Netherlands, she operates locally in every European country and is dedicated to providing unrivaled automation products and customized expert solutions for any industry.

The product portfolio includes state of the art Factory Automation services & Know-How, Sensors and Safety, Mechatronics and Drives, Industrial Components and Vision Systems.