Service Agreements
Find out more about our Service Agreements here.
More than 1,500 vial filling and closing machines worldwide give us a sense of pride: pharmaceutical manufacturers have been trusting Syntegon for more than 60 years to process their vials reliably, safely, and efficiently. Our customers process some of the most valuable and urgently needed pharmaceutical liquids, for example the new Covid-19 vaccines, oncology preparations or other biopharmaceutical drugs on our lines 24/7. From stand-alone machines to entire lines including pure media preparation, filling and closing, freeze-drying as well as inspection – Syntegon is your experienced partner for liquid vial processing!
We offer complete line solutions from a single source – from pure media preparation, filling and closing, to freeze-drying and inspection.
Purified media are a prerequisite for processing and producing liquid pharmaceuticals. Our portfolio includes both distillation and cold membrane processes for WFI, as well as thermal generation solutions for WFI and pure steam. Of course, we also offer you a well-designed system concept for the storage and distribution of PW and WFI.
Our formulation systems, in turn, support you in producing the actual solutions. From preparation and filtration to centrifugation and chromatography – ask our experts and they will be sure to propose the right solution for your products.
Benefits:
Sterility matters across the entire aseptic process – before, during and after sterile filling. Syntegon offers internal and external cleaning machines for vials and other containers. Once the vials have been pre-cleaned with Water for Injection (WFI), our HQL tunnel ensures safe and reliable sterilization and depyrogenation with dry heat. Following filling and capping, the vials can be transferred to our RAN external cleaning machine, which makes sure that no particles adhere to the outer sides of the vials; an important factor in protecting operators and healthcare workers. In addition we offer a vast portfolio of versatile sterilization solutions for an effective treatment of porous loads and liquids in open, semi-sealed or closed containers. The vacuum-steam, steam/air mixture and hot water shower processes support you in achieving reproducible equipment and terminal sterilization while optimizing your energy requirements.
Benefits:
Our vial filling systems combine flexibility and precision: we offer a wide range of technologies, including valve piston and peristaltic pump, mass-flow, rolling diaphragm pump, time-pressure filling – or a combination of all within our combi filling station. They all enable you to fill your products in a highly customized way. Tool-less format changes and a variable number of filling heads increase your flexibility. Subsequent sealing offers a variety of methods such as pick and place or continuous stoppering – without the use of vacuum. Continuous capping with high speeds completes the safe and reliable closing process. Quality is increased with 100% check weighing (IPC) and inline inspection systems such as empty vial inspection, stopper position, crimp quality, or print check control.
Benefits:
Aseptic filling is all about product safety – and thus the separation of operators and pharmaceutical ingredients. Isolator technology helps to build this crucial barrier. Syntegon has established a comprehensive portfolio, including open RABS, closed RABS, containment and isolator systems. All solutions are tailored to customer requirements, from machine design and development to on-site installation and validation.
Benefits:
The freeze dryer developed by the Syntegon subsidiary SBM is a true allrounder. It combines modularity and a flexibile design, making optimum use of the available space while processing a wide array of container sizes and formats. As such, the GMP-compliant freeze dryer is not only suited to produce small and large batches. It also pays off regarding energy efficiency: especially light product shelves reduce the amount of material that needs cooling and heating. These intelligent solutions help to significantly shorten secondary processes and contribute to the freeze dryer’s energy-saving potential.
Benefits:
Inspection is a key quality safeguard for pharmaceuticals and contributes significantly to patient safety. It can also help to improve the entire production process. Our wide range of manual, semi and fully automated inspection machines inspects liquid and lyophilized pharmaceuticals for particles and container defects. Thanks to our long-standing inspection expertise, we offer state-of-the-art technologies for visual inspection and container closure integrity testing (CCIT), including high voltage leak detection (HVLD), static division (SD) and headspace analysis (HSA). During the filling process, inline inspection systems for empty vials, stopper position or crimp quality further increase product quality.
Benefits
Automation (SODA/SCADA)
Efficient pharmaceutical production requires flexible equipment with robotic applications and comprehensive services. But that’s not all: making use and managing huge amounts of process data is just as important. Take our data acquisition solutions: they help you to reliably monitor and record crucial process data on both line and container level. SCADA (supervisory control and data acquisition) provides real-time machine and process data in one dashboard, thus enabling transparent line and batch control. SODA (single object data acquisition) fosters supply chain security by managing data for single containers, preventing time and cost-intensive incidents like complaints.
Benefits:
The Syntegon company SBM (Schoeller-Bleckmann Medizintechnik) offers a vast portfolio of versatile sterilization solutions for an effective treatment of porous loads and liquids in open, semi-sealed or closed containers. The vacuum-steam, steam/air mixture and hot water shower processes support you in achieving reproducible equipment and terminal sterilization while optimizing your energy requirements.
Benefits:
The FLC 3000 has set trends and delivered proof in many customer applications: its unique combination of flexibility and compact design have made it the preferred choice for safe and efficient filling and closing of vials and infusion bottles in the medium and high output range: 600 vials per minute are possible with a filling range of 0.2 to 500 milliliters. This is achieved with only three format part sets and minimal changeover times. No pharmaceutical filler was built as often as the FLC – with more than 650 installations worldwide.
Three different versions for high-output production: this sums up what the ALF 5000 has in store for you. The latest generation of the proven ALF series of filling and closing machines achieves high outputs of up to 36,000 vials or ampoules per hour, or both on the combi platform. The next level pharmaceutical design and remarkable accessibility make the ALF 5000 a benchmark in the mid and high-performance range. Hygienic operations are another mainstay, as the easy-to-clean machine shows a lower contamination tendency. It further features an optional 100 % in-process control (IPC) at constant speeds – up to 600 vials per minute.
The MLF 3000 filling and closing machine for vials and infusion bottles combines medium output with the highest flexibility. Its modular design and large processing range from 2 to 500 milliliters make it ideally suited for versatile applications. You can achieve output rates up to 200 containers per minute. Monoblock versions including crimping are also available, still featuring a small footprint.
If you are looking for a flexible filling and closing machine for industrial small-scale production and studies of pharmaceutical liquids in vials, our ARF 1000 is the right choice. The intermittent, rotary machine achieves an output of up to 7,200 containers per hour. You receive the highest flexibility and efficiency combined with a small footprint. The optional 100 % in-process control (IPC) adds to safe and reliable results. We also offer a monobloc version with integrated or separated capping including inline inspection systems. And for everyone looking for even more flexibility: the ARF is also available as a combi machine for vials and ampoules in the smallest space.
The FLT 1000 is your filling and closing machine for clinical trials and small batch production. Its small size, however, doesn’t mean it’s short on features: it combines a large part of the functionality of machines in the medium output range with minimum space requirements. A full-featured filling system ensures automated production and limits product loss. With its output of 30 vials per minute, the FLT fits in every lab or production facility.
“Syntegon Technology’s line competence was exactly what we needed.”
– Bo Seligmann, Director Production Support at Bavarian Nordic
New biotech vaccines are changing the way we prevent illnesses. However, they also pose several challenges in R&D, scale-up, and safety – and must be cost-effective and ensure a fast time to market. Bavarian Nordic opted for state-of-the-art technology and expertise from Syntegon for its new isolator filling line for freeze-dried and liquid vaccine serums.
“The cooperation between Syntegon Technology and Sanofi was exemplary, from ordering to start-up and subsequent service support.”
– Dr. Daniel Wagner, Sanofi
Sanofi selected the MRD 1010 filling and closing machine for small-scale test series, before transferring the defined parameters to commercial equipment. The machine was adapted with a focus on flexibility: the line is now suited for small-batch filling of up to 50 liters and covers different vial and cartridge sizes.
Find out more about our Service Agreements here.
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Our solutions for vial liquid
Together in the fight against Covid-19
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