Ever smaller batches for individual therapeutic approaches, new cost-intensive biopharmaceuticals, and the Covid-19 pandemic are currently changing the pharmaceutical industry more rapidly than ever before. Syntegon Technology showcases solutions to these challenges at the virtual ACHEMA Pulse from June 15 to 16, 2021. "Highly flexible filling technologies with maximum yield, fast product and packaging changeovers, shorter production and delivery times, and digital technologies–these are the hot topics in the industry, and for which we present innovative answers," says Dr. Andreas Mattern, director global product management pharma at Syntegon Technology.
SVP Essential: new basic version with short delivery times
Under the name SVP Essential, Syntegon has launched a new, cost-efficient version of its proven Pharmatec SVP process systems. With its modular design, customers receive a fully automated, ready-to-use solution for the production of small-volume liquid parenterals. Syntegon has developed a series of functional modules that can be assembled in a modular system. This reduces the engineering effort and ultimately the delivery time to six months. The compact system is supplied as a "package unit" with a technology skid in the clean room, enabling customers to easily install it independently. The Syntegon experts merely carry out the commissioning on site.
Modular small batch solution: Versynta Flexible Filling Platform
Syntegon bundles solutions for small and micro batches in the new Versynta portfolio. The modular Versynta Flexible Filling Platform (FFP) for aseptic and highly potent liquid pharmaceuticals is individually configurable and available with an integratable isolator. It achieves high product yields at low outputs of up to 3,600 containers per hour, amongst others thanks to 100 % in-process control. The machine can be converted to a wide range of containers and different filling systems. The Pharma Handling Unit ensures safe and gentle transport by transferring the containers from one station to the next without glass-to-glass contact.
New, patented loading system for freeze dryers
With the new, patented loading system for freeze dryers, the Syntegon product brand SBM (Schoeller Bleckmann Medizintechnik) achieves considerable space savings and maximum process reliability, says the company. With the front pusher design and its innovative drive, movement is no longer accomplished by a hydraulically operated pusher arm, but via the mechanical servo drive of the loading unit. The entire system can be installed within the isolator dimensions while the drive unit is placed outside the product handling area. This innovation saves a lot of space in the fill-finish area and avoids possible contamination. Thanks to the improved accessibility, maintenance work can be carried out quickly and without integrity loss in the isolator.
GKF 60 capsule filling machine: high dosing flexibility with a small footprint
The GKF 60 for capsule filling in laboratories is a mobile unit that facilitates the development of new formulations with a wide variety of dosing systems–flexibly and at different OEB levels. Scale-up to production is also easily accomplished, according to Syntegon. With six stations and a total of three filling stations that can be integrated in parallel, the machine is extremely compact and flexible. The smallest quantities from 0.1 milligram filling weight can be filled without product loss on the piezo station. Depending on the chosen version (standard, containment, or combi), the GKF 60 is suitable for both simple and highly potent formulations from OEB3 to OEB5.
Sepion Coater: experience meets innovation
The Sepion coater series from the Hüttlin product brand features closed material handling as well as high spray rates at very low relative standard deviation (RSD). The drum can be filled with flexible batch sizes between 10 and 100 % of the working volume. The optimized drum geometry with its sophisticated spraying system offers better guidance of the process air and shorter process times with high yields. In addition, the spray arm can be automatically adjusted for filling heights. As a result, the new Sepion coater and its containment options ensure an optimum and reliable coating process–which is currently being implemented in the first greenfield projects in Europe and Asia.
MIRA: from preventive to predictive maintenance
With MIRA (Machine Intelligence Reporting & Analytics), Syntegon is taking the next step in digital services. The modular software solution developed by Syntegon for the intelligent monitoring of process-critical components makes downtimes foreseeable and ensures trouble-free production operations. For example, anomalies in fans can be detected by temperature and vibration analyses up to six weeks before a potential costly failure. As a stand-alone predictive maintenance system, MIRA operates in parallel with ongoing operations and does not interfere with machine controls.