Annex 1 compliance as a competitive advantage

May 29, 2026 | 3 min read

Together with Syntegon, global dental health leader Inibsa upgraded its production to meet EU GMP Annex 1 requirements. The successful RABS retrofit resulted in faster approvals, less contamination risk, and new business opportunities.

Key takeaways
              According to EU GMP Annex 1, RABS is mandatory for new pharmaceutical product approvals.
Co-creation in action: Inibsa upgraded an existing line with RABS together with Syntegon. 
Annex 1 compliance as growth driver: Inibsa won a new CMO customer following RABS upgrade.

            

EU GMP Annex 1 has fundamentally changed pharmaceutical manufacturing. One of its objectives is to separate the aseptic process area from the operator environment to minimize human intervention and the risk of contamination. The regulation recommends barrier technologies like isolators and Restricted Access Barrier Systems (RABS). Hence, pharmaceutical manufacturers and Contract Manufacturing Organizations (CMOs) require at least RABS for the approval of new products.

Inibsa: dental market pioneer

For Inibsa, a leader in the global dental market, Annex 1 compliance was not optional. At its headquarters in Lliçà de Vall near Barcelona, Inibsa produces medicines for its customers as well as its own products. During its latest adaption, the company divided its production into two separate sterile areas, one of which is dedicated to RABS-equipped fill-finish operations.

“During the ordering process of the new line, we quickly realized that we also wanted to upgrade one of the existing lines with RABS – and knew that Syntegon has the technical expertise and experience we needed in an area that was new to us.”

Enara Pedroviejo, Production Manager at Inibsa

A trusted partnership: Syntegon, Imco, and Inibsa

To equip the new sterile area with the matching equipment and expand production capacities, Inibsa decided to purchase a new filling and closing line with integrated RABS and turned to its established partners Imco and Syntegon. In the highly competitive Spanish market, Imco acts as first point of contact to local companies for global equipment supplier Syntegon and has facilitated many important projects over the years.

“Inibsa has always strived to be a pioneer in product development and services for our CMO customers, dental professionals, and patients. The same of course accounts for our production facility, which we are continuously expanding and adapting to meet new requirements.”

Raquel Arenós, Chief Operating Officer at Inibsa

RABS upgrade for faster Annex 1 compliance

Drawing on experience from more than 30 RABS upgrades, Syntegon tackled key technical challenges:

aligning 21 glove ports to operators of varying heights
integrating Syntegon’s KHD 3000 online glove testing system, which tests all gloves simultaneously and transfers data to the HMI via Wi-Fi
enabling operators in an intensive multi-shift training on the gloves, ports, and testing system

A mobile mock-up frame allowed the team to simulate all routine interventions before installation, ensuring the best possible ergonomic setup for every operator. Following the mock-up phase, the existing MLD filling and closing line was retrofitted with the RABS system.

Collaboration for further growth

Looking back at the project, the Inibsa experts agree that a RABS retrofit is a major intervention. “Whoever wants to implement such an upgrade must know that it has a significant impact on both the site capacity during the project and the overall OEE of the line. Hence, it is very important to realize the implementation as quickly as possible to keep downtimes to a minimum,” Enara Pedroviejo explains.

“A close collaboration with the project partners is essential for success,” Raquel Arenós adds. “And once the line is running smoothly, it significantly reduces contamination risks and increases quality – which is exactly what the inspection authorities and our customers expect from an industry leader.” In fact, Inibsa has already won a new customer for their CMO business, which would not have been possible without an Annex 1-compliant line.