‒ PHARMACEUTICAL PROCESS MANUFACTURING
Batch, continuous or hybrid?
There is no one-size-fits-all approach to pharmaceutical manufacturing for oral solid dosage forms. The right approach depends on the product: its volume, complexity, development stage and speed to market. Batch has long been the standard, but continuous manufacturing is now a proven alternative that can support a product from development through commercial production.
THE STANDARD
Batch Manufacturing
For decades, batch has been the standard way to produce oral solid dosage forms, and it remains the right approach for many products today.
A NEW ROUTE
Continuous manufacturing
In 2015, the FDA approved the first continuously manufactured drug product, marking an important step toward faster, more efficient production and scale-up.
CONTINUOUS GOES MAINSTREAM
An established option
With ICH Q13 providing a clear regulatory framework, continuous manufacturing is a proven alternative to batch, with FDA self-audits showing applications approved nine months faster.
WITH GEA
ConsiGma® platform
One continuous manufacturing platform designed to take your product from development through to commercial production, bringing development, scale-up and manufacturing together.
From first question to full production
Not sure which process fits your needs?
‒ WHAT IS CONTINUOUS MANUFACTURING
Every step connected in one continuous process
Continuous manufacturing connects the individual steps of tablet production, so material moves through the process without intermediate storage. Quality is monitored in line while production continues, rather than assessed only after a batch is complete.
The formulation determines the process route. ConsiGma® supports continuous wet granulation, continuous dry granulation and continuous direct compression.
Select a process route
‒ CONSIGMA® CONTINUOUS MANUFACTURING
Meeting the demands of modern drug manufacturing
As pharmaceutical products become more complex, manufacturers need greater control, flexibility and efficiency across the process. ConsiGma® continuous manufacturing can help address these demands, from complex formulations and containment to quality, cost and sustainability.
‒ EXPLORE THE CONSIGMA® PORTFOLIO
Find the continuous platform for your product
ConsiGma® gives you a continuous manufacturing platform for every stage of your product journey. Choose the process route and configuration that best match your formulation, development stage and production goals.
‒ WHY GEA
Experience built into every process
ConsiGma® brings together deep process expertise, end to end capabilities, an integrated control strategy and smarter development tools in one continuous manufacturing platform.
A 6 Sigma inspired platform by design
ConsiGma® combines deeper process understanding, in line measurement and closed loop control to support consistent quality from development through production.
Ready to explore continuous manufacturing?
‒ IN PRACTICE
See what continuous manufacturing can deliver
Explore customer applications, technical studies and collaborations showing how ConsiGma® supports development, integrated production, process control and resource efficient manufacturing.
Hovione and GEA form strategic partnership to advance Continuous Tableting
Hovione and GEA today announced a strategic collaboration to advance Continuous Tableting. This partnership stemmed from a successful customer-supplier relationship spanning several years. It combines GEA´s engineering expertise with Hovione´s development and manufacturing experience and both parties commit to partner to accelerate the adoption of Continuous Tableting technology.
ConsiGma® CDC 50 Completes 120-Hour Trial Run
We at GEA, in collaboration with MSD, a tradename of Merck & Co., Inc. (Kenilworth, NJ, USA), recently conducted a successful robustness trial on GEA’s ConsiGma® CDC 50 Continuous Direct Compression system for a period of 120 hours. The positive outcome highlights the suitability of the technology — known as continuous manufacturing — for the efficient completion of campaigns that formerly involved longer and more complex batch processes.
GEA supports Pfizer to change from batch-based to continuous manufacturing
With the recent inclusion of a suite of fully automated, highly efficient production equipment to manufacture tablets and capsules, Pfizer’s plant in Freiburg, Germany, has been transformed into what the company calls a “Smart Factory.”
Continuous Innovation: How GEA is Leading the Future of Pharmaceutical Manufacturing
From the first ConsiGma® line in 2004 to the launch of CDC Flex today, GEA has been at the forefront of pharmaceutical innovation.
Continuous innovation is our commitment — to our customers, to the industry, and to a better world.
New research highlights exceptional containment performance of the GEA coater
The containment performance of the GEA Coater, described as a “new generation” device capable of both continuous and batch film coating, was assessed during three phases of operation and discussed in a peer-reviewed journal
