Soluções completas para o processo de Envase de líquidos

Soluções completas de linha

Oferecemos soluções completas de linha a partir de uma única fonte — desde a preparação de mídias purificadas, enchimento e fechamento, até a liofilização e inspeção.
Seja o seu produto líquido, cristalino, liofilizado, oleoso, viscoso ou uma suspensão — nós podemos envasar todos eles!

Pure media & formulation

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.

Benefits:

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

Cleaning & sterilization

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

Filling & closing

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:

  • Modular machine set up with barrier systems – all integrated and harmonized from a single source
  • Various integrated inline inspection systems
  • From small batches to high speeds with 600 vials per minute, including 100 % IPC

Barrier systems

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:

  • Modular machine set up with barrier systems – all integrated and harmonized from a single source
  • Various integrated inline inspection systems
  • From small batches to high speeds with 600 vials per minute, including 100 % IPC

Freeze dryers

Our pharmaceutical freeze dryers offer unmatched quality with the perfect mix of standardization and customization. With multiple configurations available, there will be a solution that fits your needs. The Telstar brand has experience managing a wide range of container sizes and formats which guarantee the best production assurance. Our freeze dryers are ideal for small and large batch production: from 1 to 60 m2, under isolator or RABS, and connecting with filling lines with different loading and unloading solutions.

Benefits:

  • Seamless integration with upstream and downstream equipment through harmonized interfaces, components, and documentation.
  • One or two-story configurations.
  • Cold shelf loading down to -45ºC without compromising loading speeds.
  • Single side or passthrough loading and unloading available.
  • Internal workshop to assure the best pressure vessel quality, including the shelf stack.

Inspection

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

Automation

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

Sterilization

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

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