At Interphex, Syntegon will showcase pharma and biopharma solutions designed to address industry requirements – from regulatory compliance and high performance to scale-up. 

Annex 1 compliance

Syntegon will address regulatory compliance with EU GMP Annex 1 for aseptic liquid filling. “Our new SynTiso platform for commercial-scale aseptic filling perfectly underlines our claim ‘Cocreate. Cosucceed.’,” said, Dr. Laura Moody, Director of Product Management Pharma North America. Syntegon developed SynTiso in collaboration with two multinational partners from the industry. It is designed to increase automation at high speeds and reduce operator intervention with a gloveless isolator and contactless transport system. 

Seamless integration

Syntegon will showcase its dedicated vial solutions. From filling with integrated isolators to loading and unloading systems and freeze-dryers: By uniting their portfolios, Syntegon and Telstar can offer customers seamless vial processes with reduced interfaces and lower product risk from a single source, according to the companies. 

New AIM Prep for offline visual inspection recipe tuning

The new AIM Prep is an all-in-one offline inspection unit that allows pharmaceutical manufacturers and CDMOs to replicate a full AIM inspection setup, including camera, lighting, vision system, and spinning speeds. It can be used to build, fine-tune, and create inspection recipes or for training purposes without interrupting production. Once the recipe is finished, it can be validated immediately and transferred to production-scale equipment.

RMA: scaling up assembly for anti-obesity drugs

The RMA showcased at Interphex, according to the company, provides GMP quality and operator-friendly design, while ensuring seamless scale-up to fully automated, large-scale production equipment like the MXA from Syntegon. The RMA was developed in close cooperation with customers and supports pharmaceutical manufacturers and CDMOs in assembling different device types with high flexibility.

Lifecycle from lab to global scale

For oral solid dosage (OSD) production, Syntegon offers a portfolio of processing equipment from lab to global scale. The R&D tabletop mixer Mycromix granulates batch sizes between 0.5 and 10 liters. It features the same Gentlewing impeller as the production-scale high-shear mixers, enabling scale-up. Mycromix is complemented by Solidlab 1 for feasibility studies, and Solidlab 2 for DoE and scale-up. Both can be used with either a fluid bed or a drum coater module and are equipped with the Provicon control system featuring open recipe creation and management for time-saving product development.