Dry powder filling machines

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!

Our expertise

Antibiotic powders for injection

Sterile powders are a common and important dosage form for active molecules that are not stable in an aqueous/liquid environment and cannot be marketed as ready-to-use injectables. Typical molecules in this category include beta-lactam antibiotics such as penicillin, cephalosporins, or acyclovir.

Micro pellets

Spray-freeze-dried pellets are an innovative drug form. Sterile medicines are freeze-dried to very small but uniform balls. The main drivers of this promising lyophilization process: higher possible concentrated protein formulations, flexibility in mixing various pellets/spheres, as well as logistic advantages.

Other sterile powders

Apart from antibiotics, there are further powders used for injection. Their formulation consists of drugs only or drug and excipient, both in a crystalline form. This dosage form is less cost-sensitive compared to directly lyophilized primary vials, since they require less energy and less infrastructure for aseptic production.

Your partner in powder filling since 1960

Solutions for complete lines

Pure media are essential utilities in parenteral pharmaceutical manufacturing. From “cold” membrane-based systems for the generation of PW, HPW, and WFI and “hot” distillation-based systems for the production of WFI and PS, to the corresponding storage systems and distribution to the point of use, our portfolio provides a comprehensive and seamlessly integrated pure media infrastructure. For your drug product compounding needs, in turn, we also offer formulation systems. Comprising a wide range of process vessels and their automation as well as all associated peripherals including media supply and CIP/SIP units, our modular processing systems truly are “the perfect match for every batch.”

Benefits:

Generation, storage, and distribution of pure media
New: cold membrane process (MWFI)
Formulation systems for multiple process steps

Our formulation systems

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:

Space-saving and flexible layout of cleaning machines
Cleaning with ultrasonic bath
Proven dry-heat sterilization with optimal tunnel design

Our cleaning machines

Our vial filling systems combine flexibility and precision: a wide range of technologies, including auger dosing, pressure vacuum, or slide chamber dosing, make sure you can fill your products in a highly customized way. Tool-less format changes and filling stations with a variable number of filling heads increase the flexibility of your filling processes. Subsequent sealing offers you a variety of methods such as pick-and-place or continuous stoppering. Continuous capping with high speeds completes the safe and reliable closing process. 100 % in-process control (IPC) check weighing and inline inspection systems for empty vials, stopper position or crimp quality further increase product quality.

Benefits:

Modular machine set-up reduces production costs
Integrated inline inspection systems
Speeds up to 480 vials per minute, including 100 % IPC

Our vial filling machines

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:

Integration instead of interfaces
Aseptic and high-potent applications
Rapid bio-decontamination cycles

Our barrier systems

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:

Stand-alone and inline inspection solutions
Camera-based and light transmission-based visual inspection
Cutting-edge, patented CCIT technology

Our inspection machines

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:

SCADA: detailed overview of all operations and processes
SCADA: recording and analysis of errors
SCADA: centralized access to individual machines and entire lines
SODA: risk reduction during production
SODA: traceability at container level

Our digital solutions

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:

Wide process range
Hygienic design
Flexible recipe editor for customized processes
Automatic in-line filter sterilization

Our sterilizers

AFG 5000

The AFG 5000 is the innovation for filling and closing sterile powders in vials. It features a specially developed transport system that adjusts the speed during filling, weighing and stoppering to speed up the workflow. The 100 % in-process control (IPC) avoids any unnecessary product loss – an important advantage when producing cost-sensitive antibiotics such as penicillin or cephalosporins. Our highly flexibel AFG is available in several machine versions with different features and output rates from 160 up to 480 vials per minute.

ALF 5000 P

The ALF 5000 P series fills and closes sterile powders in the medium and high-performance range. It is especially suited for antibiotics for humans and animals such as penicillin or cephalosporins. Moreover, it can also be used to fill highly potent powder drugs like cytotoxics or cytostatics into vials. The machine series is especially flexible and has a very compact design. You have the choice: the ALF P can process vials from 2 to 250 milliliters with outputs of up to 7,500 vials per hour.

ARF 1000 P

If you are looking for a flexible filling and closing machine for industrial small production and studies of pharmaceutical powders, our ARF 1000 P is the right choice. The intermittent, rotary machine achieves an output of up to 6,000 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.

Our solutions have got you covered

Size as a cost factor

The larger the filling area of a machine, the higher the costs for containment, filtration, temperature control, operation, maintenance, and cleaning. Every centimeter or inch counts; especially in cleanroom class B, where powders are usually filled. We offer you a modular machine design that gives you the flexibility to choose between different filling and weighing modules, which provides further space savings.