Annex 1: RABS upgrade instead of new equipment

Syntegon MLD filling closing machine cartridges

In light of the new version of Annex 1, which came into force in August 2023, many pharmaceutical manufacturers are facing the question whether they must invest in new equipment. However, in many cases upgrades are a good alternative, as the Danish company AJ Vaccines showed. Together with this customer, Syntegon modernized an older MLF 3002 vial filling and closing machine with a complete RABS.

According to the revised EU GMP Annex 1, sterile production must take place under RABS or isolator conditions to ensure maximum product and operator protection. Glove ports are needed to avoid opening of glass doors, for example to change settle plates for environmental monitoring or in the case of manual interventions through the glove ports.

Action instead of reaction

However, particularly with older machines, this is not always the case. Manufacturers must therefore invest in new equipment with pre-installed barrier technology – or upgrade the existing. Syntegon offers both options, but for Danish pharmaceutical company AJ Vaccines, the decision was not a difficult one: Syntegon's MLF 3002 vial filling and closing machine has been running smoothly for the past few years. After a technical audit and some minor optimizations, the machine also had a very long expected service life. The company therefore contacted the experts at Syntegon at an early stage to find out about a RABS upgrade – and took immediate action.

AJVaccines-before-upgrade-with-mock-up-frame

Focus on user-friendliness

The project started with the mock-up phase, which is essential to determine the exact scope of the upgrade, including the type of RABS, the position of the glove ports, and further details. Since the upgrade brings a number of changes for the operating staff, Syntegon used the chance to make their work with the new system as ergonomic and user-friendly as possible. They tested the work steps beforehand with a selected group of operators with a mock-up frame to find the ideal average position.

After establishing the project plan and defining milestones, the engineers from Syntegon developed a comprehensive 3D model of a passive open RABS. Apart from the new RABS, the design further included the exchange of the former rotary valve piston pump with RTU filling paths and the connection to a third-party pump trolley. Again, the project team paid special attention to user-friendliness by optimizing the processes to transfer equipment into the machine.

Annex 1-ready, not just in Denmark

Following the successful installation of the system, the Syntegon experts were on site again to accompany the first batch and check whether the machine was running according to plan. The result not only convinced this customer: Syntegon is supporting numerous pharmaceutical manufacturers all over the world in becoming “Annex 1-ready”. RABS upgrades offer customers an extensive choice of options, including peripheral topics such as viable monitoring, new stopper infeed solutions, or glove integrity testing devices.