Modernizations for lasting equipment performance

Key Takeaways
              Modernizations protect long-term investment in pharmaceutical equipment by prolonging productive service life.
Retrofits and tailored upgrades keep existing equipment compliant with evolving regulatory requirements and reduce resource consumption.
Automation and digitalization increase operation efficiency and reduce the risk of unplanned downtime.
Original parts and proactive parts planning support a safe and reliable operation.
Syntegon Lifecycle Services support manufacturers from initial assessment and implementation to maintenance and continuous optimization.

            

Purchasing pharmaceutical equipment means making a major long-term investment. At the same time, machines age while new technologies enter the market. Pharmaceutical as well as nutraceutical and biotech manufacturers also need to adapt to evolving market and regulatory requirements and growing demands for safety and sustainability. With the right modernization strategy, manufacturers can effectively prepare their equipment for future requirements. As a strategic lifecycle partner, Syntegon supports manufacturers throughout this process, combining regulatory and manufacturing expertise with state-of-the-art technology – from single technical upgrades to fully customized solutions.

Achieving compliance that lasts

While the right equipment can remain productive for decades, regulations rarely stand still. Targeted modernizations help manufacturers address emerging compliance gaps without having to replace existing equipment. For the growing market of oral solid dosage (OSD) medication with highly potent APIs, for instance, fitting containment measures are necessary to protect product and operators. This is why Syntegon offers two solutions for upgrading existing capsule filling and tableting equipment: ProTect for applications up to OEB 4 and HiProTect for high-potency applications up to OEB 5.

For sterile filling, EU GMP Annex 1 is placing greater emphasis on barrier technology and reduced operator intervention. Manufacturers can upgrade their existing equipment with Syntegon’s open or closed RABS tailored to the existing line. Further upgrades for Annex 1 compliance include glove integrity testing for barrier systems, PUPSIT for testing sterilized membrane filters before use, and the Settle Plate Changer (SPC) for automating the viable monitoring process. Syntegon experts conduct and support manufacturers throughout these retrofit measures, from gap analysis and retrofit planning through implementation.

“Existing equipment will remain in production for many years. With modernizations, pharmaceutical manufacturers can adjust their proven equipment to the increasing requirements of Annex 1.”

Dr. Johannes Rauschnabel, Senior Director Pharma Excellence at Syntegon

Keeping performance up to date

Even the best equipment needs regular updates to perform reliably throughout its lifecycle as aging components can slow down production speed and increase the risk of unplanned downtime. This is where Syntegon’s cloud-based software solution Synexio comes in. By collecting and analyzing production data, it provides insights into equipment health, supporting predictive maintenance and helping manufacturers address issues before they affect efficiency or even lead to unplanned downtime.

Software tools and upgrades can deliver value beyond equipment maintenance: In solid dosage R&D, for example, optional Automated Design of Experiments (DOE) reduces development effort and API consumption by minimizing repeated trials. Based on this, an Automated Process Development (APD) tool helps determine the ideal process parameters for the final product. From there, Syntegon supports the transition to larger production scales with the HMI V6. It helps integrate additional equipment and digital services, all while improving data collection and process transparency. This creates greater process continuity from development to production, supporting efficient scale-up.

Reducing resource consumption

Targeted upgrades can help reduce water and energy consumption in energy-intensive processes such as sterilization. Syntegon therefore analyzes relevant process parameters to identify savings potential and recommend suitable modernization measures. An additional sensor in the jacket cooling system regulates the temperature as needed. Keeping the cooling water in the circuit up to a specified temperature setpoint results in significant water savings. Retrofitting a vacuum pump with a pre-separator further reduces freshwater consumption. Combined, these measures can reduce water consumption during sterilization by up to 70 percent.

Small parts, big impact

When manufacturers do decide to opt for modernizations to preempt compliance issues, improve performance, or lower resource consumption, the decision on the who and how matters, too. Even small components can significantly impact operation. Counterfeit or low-quality replacement parts can increase the risk of product contamination, machine damage, production failures, and costly repairs. As an OEM, Syntegon draws on in-depth equipment knowledge to design original parts for seamless compatibility and reliable long-term operation.

Proactive parts planning is equally important for maintaining equipment availability. The Recommended Parts Inventory analysis identifies which critical components to keep in stock, while Preventive Maintenance Kits provide the parts needed for scheduled maintenance.

Benefits at a glance
              Regulatory compliance: Tailored upgrades help existing equipment adapt to evolving regulatory and containment requirements. 
Higher performance and availability: Hardware, software, automation, and digitalization upgrades help maintain efficiency and reduce unplanned downtime. 
Safe and reliable operation: Original parts and proactive parts planning ensure reliable long-term operation. 
Greater resource efficiency: Targeted modernizations in sterilization can reduce energy consumption and save up to 70 percent of water. 

            

A lifecycle approach to modernization

Requirements will continue to evolve throughout a machine’s lifetime, making modernization an essential strategy for manufacturers. As a strategic lifecycle partner, Syntegon is there every step of the way, from initial assessment and implementation to parts, maintenance, and ongoing optimization.

Is your equipment ready for what comes next? Get in touch with your local Syntegon experts to assess your installed equipment and help develop the right modernization strategy for you.

Contact our experts

Modernizations for lasting equipment performance

Key Takeaways

Achieving compliance that lasts

Keeping performance up to date

Reducing resource consumption

Small parts, big impact

Benefits at a glance

A lifecycle approach to modernization

Interested in our pharma solutions?

Discover more about Syntegon

Modernizations for lasting equipment performance

Key Takeaways

Achieving compliance that lasts

Keeping performance up to date

Reducing resource consumption

Small parts, big impact

Benefits at a glance

A lifecycle approach to modernization

Syntegon Newsletter

Interested in our pharma solutions?

Discover more about Syntegon