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    Formulation
    Formulation

    Pharmaceutical formulation

    Small and large volume parenteral drug product formulation

    In pharmaceutical formulation, where the equipment functionality required is highly dependent on the drug product type, modularization is proving a decisive design advantage to help meet the need for both process flexibility and exceedingly short delivery times. Syntegon’s SVP and LVP modular solutions for batch sizes ranging from 13-20,000 liters are suitable for the GMP manufacture of small volume parenterals (SVP), large volume parenterals (LVP), infusion products (IV), as well as buffer and media preparations. We offer a full range of process vessels and their automation as well as all associated peripherals including media supply, CIP/SIP systems, and the filling line interface. 

    Our expertise in pharmaceutical formulation

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    Small volume parenterals

    Processing systems for small volume parenteral pharmaceuticals using fully standardized platforms based on off-the-shelf functional modules.

    pharmaceutical-formulation-large-volume-parenterals
    Large volume parenterals

    Processing systems for large volume parenteral pharmaceuticals using Syntegon standards to deliver highly customized solutions.

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    Line Integration

    Full line integration for an optimized plant layout incl. pipe routing and material flow with coordinated processes and adapted alarm functions.

    From drug substance to drug product

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    Pharmaceutical formulation development

    Our SVP/LVP process systems are highly modular and flexible solutions for the production of liquid pharmaceuticals. Where desirable, they feature a prefabricated integrated cleanroom design with all peripheral technology outside the cleanroom in technical skids. The production area itself can also be separated and run under different room classifications as required by the application. We provide the highest degree of flexibility in both the layout of your room concept and the configuration of the production units themselves. 

    Benefits
    • fully standardized platform based on off-the-shelf functional modules for unparalleled flexibility and convenience
    • pre-fabricated with a pre-tested modular building set for substantial cost savings and accelerated delivery
    • fully integrated and automated solution
    • optional integrated interface to filling with shared CIP/SIP for streamlined delivery and additional savings
    • designed in cooperation with customers for user friendliness and ease of maintenance

    Modular formulation systems – step by step guide

    drug-formulation-system

    Why a modular approach?

    In pharmaceutical formulation, where the equipment functionality required is highly dependent on the drug product type, modularization is proving a decisive design advantage in meeting the ever greater need for both process flexibility and short delivery times.

    Our modular formulation system concept

    Our drug formulation systems are fully standardized platforms based on off-the-shelf functional modules. Where desirable, they feature a prefabricated integrated cleanroom design with all peripheral technology outside the cleanroom in technical skids. The production area itself can also be separated, and run under different room classifications as required by the application. Our pharmaceutical formulation solutions provide the highest degree of flexibility in both the layout of your room concept and the configuration of the production units themselves. We jointly define the shape, volume, and functionality of the fixed and mobile containers to deliver exactly the preparation system you need for your drug products. Over 70 pre-tested functional modules are available to process batch sizes from 13 to 20,000 liters, offering unparalleled flexibility and convenience.

     

    From mobile homogenizers to integrated CIP/SIP modules, a full range of options for pharmaceuticals formulations are available. For example, the prefabricated integrated cleanroom design can even include the laminar flow and lighting units. And since the safety of operators and products comes first, we can meet complex requirements such as aseptic processing or the handling of toxic substances simply by adding the appropriate functional modules.

    Our automation architecture, which is structured according to ISA-88, is one of the foundations of our modularization concept. Mechanics, electronics, and software merge into intelligent mechatronic modules in our systems. Your individual recipes can be implemented in three different ways on the SVP/LVP process system: program, production, and batch management sequences. The result is unparalleled flexibility in production monitoring and control. We thrive defining trends and driving digital production in drug formulation. The modularity of the Syntegon formulation platform, and the flexibility it provides, makes for a highly compelling solution for a full range of clinical to commercial liquid pharmaceuticals formulations applications. The system is, truly, “the perfect match for every batch."


    Key features of an effective modular formulation solution:
    • fully standardized platform based on off-the-shelf, pre-tested functional modules 
    • joint configuration selection for the right functionality and ease of operation
    • all functional modules are controlled by the same automation system 
    • mechanics, electronics, and software merge into intelligent mechatronic modules 
    • line integration interfaces incl. pipe routing and material flow with coordinated processes and adapted alarm functions 

    The systems comprising Syntegon's pharmaceutical formulation solutions

    The Syntegon drug formulation solutions provide everything you need for a highly flexible yet seamlessly integrated system infrastructure. We offer a full range of process vessels, their automation, as well as all associated peripherals including media supply, CIP/SIP systems, and the filling line interface.

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    SVP pharmaceutical formulation system

    Our SVP process system is a highly modular and flexible solution for the production of small volume parenterals (SVP). It features a prefabricated integrated cleanroom design with all peripheral technology outside the cleanroom in a technical skid. The production area itself can also be separated, and run under different room classifications, as required by the application. We provide the highest degree of flexibility in the layout of your room concept and in the configuration of the production units themselves.

    formulation-SVP-essential

    SVP Essential pharmaceutical formulation system

    The SVP Essential liquid formulation system is a new 1- or 2-vessel standardized variant of the highly versatile SVP platform. Ideally suited for simple aqueous solution and suspension parenteral products, the SVP Essential is designed for process flexibility with ultra-fast delivery. The customer receives the precise functionality required for the intended range of products in a drop-in configuration that can be rapidly delivered, installed, qualified, and put into operation. The SVP Essential has a clear value proposition: GMP process flexibility with unparalleled speed and convenience.

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    LVP pharmaceutical formulation system

    The LVP process system uses Syntegon standards to deliver highly customized solutions for the production of large volume parenterals (LVP), infusion products (IV), as well as buffer and media preparations. The liquid preparations are carried out in modular temperature-controlled stainless-steel tanks with all the appropriate functionality to cover the full range of your product recipes. All LVP solutions follow the applicable compendial (e.g. USP, EP) as well as regulatory (e.g. DIN, ASME, GMP, and FDA/EMA) pharmaceutical manufacturing guidelines.

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    Cleaning and sterilization in place

    Our CIP/SIP systems are designed for the purification and sterilization of pharmaceutical processing components, equipment, and systems. The internal or external CIP/SIP systems use PW, WFI, PS, and application-specific cleaning solutions with recirculation for the efficient use of the cleaning media. The smart system design guarantees simple self-purification with special dosage and heating/cooling systems providing a constant and consistent high purification quality.

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    Line integration

    The Syntegon portfolio covers the entire liquid pharmaceutical manufacturing process, from pure media generation to final product packaging. Thanks to cutting-edge engineering, a high degree of digitalization, automation, and the continuous flow of data, you receive your entire project scope fully integrated from one source. And that also includes our pharmaceutical formulation and filling solutions: our modular SVP/LVP process system truly is “the perfect match for every batch” – whether you purchase a stand-alone machine or an entire line.

    Service Agreements
    Service Agreements

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    Digital Solutions
    Digital Solutions

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    Maintenance
    Maintenance

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    Technical Support
    Technical Support

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    Modernizations
    Modernizations

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    Training
    Training

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    Expert Services
    Expert Services

    Find out more about our Expert Services here.

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    Pharmaceutical formulation downloads

    SVP flyer
    SVP flyer

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    SVP brochure
    SVP brochure

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    SVP Essential flyer
    SVP Essential flyer

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    CV-19 flyer
    CV-19 flyer

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