Pharma Industrial India Magazine - May-June 2024

Another market launch is highly important for aseptic filling processes in accordance with the EU GMP Annex 1, which came into effect in August last year and must be complied with by both European manufacturers and CMOs as well as those wanting to import their products into the European Union. The new patented Settle Plate Changer (SPC) from Syntegon for automated viable monitoring uses automation to reduce the time needed to replace settle plates – resulting in noticeably higher machine availability of up to 300 hours per year. Q How does Syntegon address regulatory and quality com- pliance requirements in its pharmaceutical manufactur- ing solutions? Dr. Andreas Mattern: As a partner to our customers, we work closely together to comply with all regulatory requirements. For instance, Syntegon’s new technologies are of course designed with the new EU GMP Annex 1 in mind. In the case of older machines, the question is whether to upgrade or invest in a completely new line with pre-installed barrier technology. Syn- tegon offers both options and analyzes customer requirements in detail to recommend the ideal solution to become “Annex 1-ready”. The numerous 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. We have a large team of experts in all regulatory and quality compliance fields. Our subsidiary Valicare has more than 20 years of experience in regulatory and GMP compliance, in- cluding qualification and validation, GMP for ATMPs. Q How does Syntegon ensure the continuous flow of data in its pharmaceutical manufacturing solutions? Dr. Andreas Mattern: Syntegon has developed a special, cloud-based software solution for pharmaceutical manufac- turing operations. Synexio enables the collection, evaluation, and visualization of machine and production data, as well as component monitoring. Synexio is part of Syntegon’s Service Agreements, which form the basis for effective equipment and maintenance management at fixed prices. Moreover, we have developed several new digital solutions for pharmaceutical filling. For example, the intelligent piston pump “Smart Pump” from Syntegon carries its memory with it on an RFID chip, even when it is not installed in the machine. The system automatically recognizes the pump, for example after cleaning – which significantly increases process reliability, re - duces human error, and saves a lot of time in ongoing produc- tion. The entire “Max Pro” portfolio for liquid filling is designed for less product loss and hence higher yields. For example, the optional twin fill process enables the optimal determination and readjustment of the filling weight via main and secondary dosing with 100% in-process control. PHARMA INDUSTRIALINDIA · MAY-JUN 24 20 INTEEWRSVIEW