ABOUT SYNTEGON PHARMA TECHNOLOGY INC.

Syntegon is one of the leading providers of process technology and packaging solutions for the pharmaceutical industry. Our portfolio includes single units, systems and complete solutions for all process steps and packaging types. Discover our packaging solutions for pharma, biopharma and fine chemicals.

FEATURED PRODUCTS

Pharmaceutical Aseptic filling is all about product safety – and thus the separation of operators and pharmaceutical ingredients. Pharmaceutical Isolator technology helps to build this crucial barrier. However, isolators must be integrated properly into existing lines to reveal their full potential.

Continuous manufacturing is changing oral solid dosage (OSD) production. Higher flexibility, shorter development times with minimum API usage, and a direct transfer from development to production without scale-up are among the primary requirements of pharmaceutical manufacturers. In continuous manufacturing, the processes occur one after the other without interruption while the product is charged and discharged simultaneously. The main challenge with traditional solutions is the precise dosing of the starting materials in a constant mass flow rate of milligrams per second.

Single station pharmaceutical tablet press with enhanced DAQ software for R&D & galenics.

Just like the multitude of pharmaceutical products on the market, sterile filling technologies each serve different purposes. With Syntegon’s wide selection of filling technologies, you can be sure to meet the most pressing challenges: from filling highly potent pharmaceuticals to ensuring sterile operations and full process data transparency, our solutions support first-class liquid filling.

Pharmaceutical powders form the basis of numerous antibiotics and other medicines that are essential for comprehensive medical care. While liquid pharmaceuticals are already challenging to fill, powders add a level of complexity due to their consistency. The finely ground active ingredients generate dust easily. Hence, machine operators must be protected from these sometimes toxic or potent ingredients and vice versa. With more than 250 machines sold globally, Syntegon has been supporting customers in pharmaceutical powder filling for more than 60 years. Our experts will be happy to pass on their expertise to you, too!

Performance meets precision in Syntegon’s pharmaceutical cartridge filling and capping portfolio. Our filling solutions for all output ranges help you process cartridges at optimum conditions. From accurate positioning under the working stations to low-particle capping with patented technologies, our cartridge filling systems reliably support each step of your production cycle. High-quality operations are equaled by a modular and space-saving design, facilitating the integration into state-of-the-art production lines.

The KKE capsule checkweighing series sets standards in 100 % capsule weighing. With its mechanical pre-dedusting system, the precise gravimetric weighing technology makes the series the ideal choice for your capsule checkweighing needs. The platforms also answer the growing needs of the nutraceutical and health industry in terms of process control and increases product quality in your capsule production. KKE models are available in OEB 4 and OEB 5 versions as well as in dust-tight and wet-clean versions for increased operator protection.

Pharmaceutical manufacturers have been trusting Syntegon for more than 60 years to process their vials reliably, safely, and efficiently. We have installed more than 1,500 vial filling and closing machines all over the world. They are used to process some of the most valuable and urgently needed pharmaceutical liquids in 24 hour operations, for instance the new Covid-19 vaccines, oncology preparations or other biopharmaceuticals.

Self-administration of drugs is on the rise - meet demands with highly automated and flexible assembly solutions.

Fast, accurate, and reliable loading of vials and cartridges.

For even smaller batches, the gloveless microBatch working cell is the perfect solution. The setup allows fast installation/validation as well as 100% in-process check weighing. A fully integrated machine and Isolator unit are key to ensure quality and output.

For the safety of personnel and customers as well as an undisturbed processing, thorough cleaning of the outside surfaces of filled and sealed receptacles such as injection bottles, ampoules, or cylinder ampoules is essential. This applies especially for highly potent and/or freeze-dried products. With the new external cleaning machine RAN 30x0 you will reach a level of cleaning quality that has never been achieved before, thus ensuring that your receptacles remain free of product residues or other containments.

The regulatory requirements regarding the traceability of pharmaceutical products are becoming more and more demanding. Cross-process solutions, which enable the tracking and identification of each filled and sealed vial, bring benefits not only in product safety and protection against counterfeiting. They also offer advantages for production itself, e.g. the possibility of logistically separating filling/sealing processes from labeling/packaging routines. With the KIV series, Syntegon offers an inline solution for coding and verifying vials that promises both high quality and high performance, and can easily be integrated in existing lines.

The ultra-high-speed output of the KKE 3800 is ideally suited to applications with more than one capsule filling machine, or for batch processing. The checkweigher has an output of up to 232,200 capsules/hour. This meets the requirements of big volume production and time-to-market.

The KKE 2500 capsule checkweigher sets the standard in the field of 100 % capsule weighing. With an output of up to 150,000 capsules per hour, the KKE 2500 is the ideal in-line partner for GKF 2500.

The KKE 1700 capsule checkweigher sets the standard in the field of 100% capsule weighing. The precise gravimetric weighing technology and ergonomic design make them the ideal choice for your capsule checkweighing needs.

For the efficient and reproducible testing of your barrier system.

The ARF 1000 is an intermittent, rotary filling and closing machine for industrial small batch production. It achieves an output of up to 6,000 containers per hour.

VIS 200 and VIS 500 semi-automatic inspection systems allow visual inspection of vials containing liquids or powdered / lyophilized products, as well as empty vials, at higher rates and with less operator fatigue than with manual inspection systems.

Syntegon has many years of experience in the manufacture of filling lines. As an optimal complement, we offer a SCADA system to support central line control and central batch recording.

Restricted Access Barrier System from Syntegon – more flexibility and quality for existing cleanrooms. More product quality due to physical separation of product and operator.

Pharmatec Fermentation Systems and Fermentation Units are designed for the production of complex solutions with multiple process steps (cascade, fermentation or dialysis fermentation). Preparation is carried out in temperature-controlled stainless steel tanks with stirring units under addition of chemicals and/or nutrient solutions. The following process steps are used: fumigation (N2, O2 and sterile air), dosage (substrate and anti-foam), concentration (base and acid). All valid pharmaceutical (e. g. USP, EP) and technical rules and standards (e. g. DIN, ASME, GMP and FDA / ISPE Guidelines) are followed and applied.

AIM 8000 - Most versatile visual inspection platform for with full modularity for customization to each product requirement!

The TPR 200 is a highly efficient, new addition to the Syntegon tablet press range. Designed for small to medium batches with outputs of over 230,000 tablets per hour.

The XL Cota is used worldwide inside the pharmaceutical industry. Its huge distribution is owned mainly to a very reliable process, which is suitable for all kind of tablet coating requirements.

Isolator systems are becoming increasingly important to the pharmaceutical industry. The improvement in product quality, the reduction of operating costs and the capability of longer production runs are significant advantages in comparison to conventional clean room production.

The GranuLean unit from Syntegon combines a high-shear mixer, a fluid bed system and the adequate material handling to a compact, standardized and easily integrated granulation suite.

Freeze-drying systems are suitable for the stabilization of thermolabile and sensitive active substances, such as oncological medicines, vaccines or antibodies.

The FXS Combi is an extremely flexible solution for pharmaceutical filling operations.

The FLS 3000 is a trendsetter, designed with leading edge technology for the filling of bulk syringes.

The pioneering cap crimping with adjustable rotation speeds offers the highest technical standard and highest Syntegon quality. The already proven, low-particle cap crimping system swivels for each container a rotary crimping disc against the beaded rim. All machine settings can be reproduced and thus the processes can be validated. The VRK series stands for safe pharmaceutical production and convinces by simple handling and high efficiency.

The latest generation of the proven ALF series offers a linear platform for the filling and closing of ampoules and vials.

Pen assembly machines from Syntegon are designed for assembly of a standard 4-piece disposable pen. The level of automation is scalable depending on the requirements and can be subsequently adapted through field modifications of the machine. The concepts are based on a rotary table for lower and medium outputs or a linear transport system for higher outputs.

At Syntegon, the development and production of sealing machines for vials and infusion bottles has a long tradition. The low-particle crimping method, in which the container is released from the transport system during crimping, became a trendsetter for modern, pharmaceutical production.

The patented loading system for freeze dryers ensures maximum process safety, while saving a considerable amount of space. Thanks to its new front pusher design, the system loads vials into the freeze dryer using the linear pushing and pulling motion of a transfer arm. Unlike other systems, the innovative transfer bar is not moved by a hydraulic push rod, but by a mechanical servo drive.

Pharmatec Process Systems for Biopharmaceutical Production are designed for the production of liquid medicines. Production of pharmaceutical liquids is carried out in temperature-controlled stainless steel tanks with stirring units under addition of chemicals with or without nutrient solutions. All valid pharmaceutical (e. g. USP, EP) and technical rules and standards (e. g. DIN, ASME, GMP and FDA / ISPE Guidelines) are followed and applied.

Modular and innovative platform for filling RTU and bulk containers. The Flexible Filling Platform is addressing especially these areas of applications. Flexibility for us means handling all different containers such as vials, syringes and cartridges. As well as modularity allowing the line to be quickly adapted to different needs by using pre-developed and pre-tested modules. The FFP has an output up to 3,600 containers/h and offers a 100% in-process check weighing.

Syntegon Technology has developed the fully automated capsule filling machine GKF Capsylon 1505 for economically filling powder, pellets, and granulates. The dosing station can fill sticky and fine grained powders precisely. The height adjustable metering disk allows for quick adjustment between product formats or filling amounts.

The capsule filling machine GKF 3000 has an output of 175,000 capsules per hour. This machine is reliable, low-maintenance, and provides production security.

With the KLD Series, Syntegon continues its long history as a leading manufacturer of leak detection machines. The latest generation of the KLD Series impresses through even more precise measurement, gentle container transport and outstanding ease of handling and maintenance.

Fully automated double sided tablet press with high OEE (overall equipment effectiveness)

Syntegon auto-injector assembly & labelling machines are designed to offer an output of 300 auto-injectors/min. The level of automation is scalable depending on the requirements and can be subsequently adapted through field modifications of the machine. The concepts are based on a rotary table for lower and medium outputs or a linear transport system for higher outputs.

Simple means reliable. Reliability in the pharmaceutical industry is a “must”. When it comes to filling lines, isolators offer tangible advantages over traditional aseptic processing – but a reliable bio-decontamination cycle for the inside of the isolator is imperative. Additionally, the cycle time has to be short to guarantee economic success of the filling line.

Pharmatec Purification Systems are designed for the production of complex solutions of harvest systems with multiple process steps (e. g. preparation, centrifugation, filtration). Production of pharmaceutical liquida is carried out in temperature-controlled stainless steel tanks with stirring units under addition of chemicals with or without nutrient solutions. Filtration units can be offered as stand-alone units. All valid pharmaceutical (e. g. USP, EP) and technical rules and standards (e. g. DIN, ASME, GMP and FDA / ISPE Guidelines) are followed and applied.

The GKF 720 HiProtect provides a high containment concept for the production of potent and costly niche products such as "orphan drugs” against rare diseases.

Continuous manufacturing is leading to fundamental changes in oral solid dosage (OSD) production. Higher flexibility, shorter development times with minimum API usage, and a direct transfer from development to production without scale-up are among the primary requirements of pharmaceutical manufacturers. Syntegon Technology is tackling these challenges with a novel approach called Xelum. In continuous manufacturing, the processes occur one after the other without interruption, the product is charged and discharged simultaneously. The main challenge is the precise dosing of the starting materials in a constant mass flow rate of milligrams per second. Syntegon uses a different approach.

CONTACT INFORMATION

Syntegon Pharma Technology Inc.

8700 Wyoming Ave N,

Minneapolis, 55445

Contact: Jerry Jean-Baptiste

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