TAPI Synthesis SM2 plant in Croatia

TAPI’s New State-of-the-Art Plant Delivers Fast, Flexible Service

By Ante Radić, Plant Manager for Synthesis SM2, TAPI Croatia

 

TAPI customers may soon have their orders filled at TAPI’s newest, most technologically-advanced API manufacturing facility in this part of Europe, with the full capability to produce a wide array of products from low to high potency APIs, and more.

 

The new state-of-the-art API plant, called Synthesis SM2, formally opened in April 2016 at our Savski Marof site in Croatia. TAPI designed the plant as a multi-purpose facility with industry-leading manufacturing capabilities to meet all of our customers’ needs. Synthesis SM2 was built with sophisticated reactors, isolation/filtration units, filter and paddle vacuum dryers, and solid handling units (isolators, down flow booths and powder transfer systems). The first phase of the plant is currently online and the facility will be fully operational by the end of the year.

New Croatia plant enhances customer experience

This is TAPI’s third production facility at this location and it is already benefitting our customers in a number of ways, including:

High tech processes that produce the highest quality APIs. In planning the facility, one of TAPI’s top considerations was the use of product containment technologies to produce the highest quality APIs while ensuring the highest level of protection for our employees. The primary containment system includes closed production equipment and systems, down flow booths, in-line and off-line cleaning. The secondary containment system provides additional protection through clean rooms, access control and sophisticated HVAC systems. Safety features and an advanced distributed control system ensure we have rigorous process control and monitoring procedures and secure data storage that meet current Good Manufacturing Practice (cGMP) requirements and EHS standards, as well as new R&D guidelines.

 

Greater production flexibility. With the flexibility to produce different APIs with different chemical syntheses operations on the same state-of-the-art equipment, the plant is able to respond more quickly to customers’ changes, such as requests to increase product quantity or an order for a different API. Currently, the plant focuses on batch production of highly potent APIs (OHC-4 level) for a variety of drug products including solid oral dosage forms and parenterals, and can accommodate orders ranging from 10 kilograms up to hundreds of kilograms.

 

Increased production capacity. With Synthesis SM2 now online, we are able to streamline supply chain processes and fill and ship orders more quickly so customers have the materials they need to begin production on time. When the facility reaches full production capacity, it will be able to manufacture as many as 20 APIs to meet market demand worldwide.

 

Strong commitments to customers and our community

Product quality and prompt response to customer requests guide us in our day-to-day activities. Employees who work at the new Savski Marof plant are dedicated to developing best-in-class products that meet or exceed industry standards and government regulations. We always keep in mind that the pharmaceutical ingredients we produce will be used in drug products designed to improve the lives and health of millions of people around the world.

 

We also take our responsibility to protect the environment very seriously. The plant uses the best technology on the market today to pre-treat wastewater and gas emissions to make them safe, and ensure our processes comply with stringent environmental standards. A sophisticated Membrane Bio Reactor (MBR) treats wastewater on site and a regenerative thermal oxidizer (RTO) provides state of the art vapor emissions reduction and control for the plant.  TAPI Croatia is committed to operating clean and green production facilities, reducing its environmental impact on the surrounding community, and improving the ecological status of the entire site.

 

Customer feedback leads to continuous improvement

We consider TAPI customers our long-term partners and we count on their feedback to help us make continuous improvements in our operations. In the short time the plant has been on line, we are pleased that we are exceeding our targets for customer satisfaction and delivery reliability, and will work hard to maintain an excellent track record.

 

As Gabriela Mateša, Plant Coordinator noted, “Customer experience means we go above and beyond the norm. It is our ability to anticipate their needs and react quickly to deliver outstanding products and services on time.” “Customer feedback is shared with all employees,” Siniša Feichtinger, Technological Process Leader, pointed out. “We know that our daily activities contribute to customer satisfaction and that empowers us to do an even better job.” Zvonimir Lacković, Technological Process Worker, feels that outstanding customer experience results from a combination of factors. “When best-in-class systems, tools and processes are combined with employee engagement and empowerment, it creates a culture of continuous improvement. It’s a new way of working and in the end, our customers will be the true beneficiaries.”

 

Ante Radić was part of the design team for TAPI’s new Synthesis SM2 facility in Croatia, and now serves as Plant Manager. He joined TAPI in 2008 when Croatian Pharmaceutical Company Pliva was acquired by Teva Pharmaceutical Industries, Ltd.

To learn how TAPI’s team of experts can meet your specialized needs, please contact us.