Skip to content
    back
    Formulation

    Drug product formulation / compounding

    Small and large volume parenteral drug product formulation

    In drug product 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

    formulation-of-pharmaceutical-solutions-1
    Small volume parenterals

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

    formulation-solutions
    Large volume parenterals

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

    machine
    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

    Please accept marketing-cookies to watch this video.
    Please accept marketing-cookies to watch this video.
    Please accept marketing-cookies to watch this video.

    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

    modular-approach

    Why a modular approach?

    In drug product 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 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 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 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 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 product 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 pharmaceutical product formulation 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 formulation solutions

    The Syntegon 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.

    formulation-SVP

    SVP 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 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.

    formulation-process-in-pharmaceuticals

    LVP 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.

    formulation-technology

    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.

    pharmaceutical-formulation-development-01

    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 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

    We support you throughout the entire machine life cycle, from spare parts management to digital line optimization. Service Agreements are a key element of our portfolio structure. Together, we tailor our solutions to your individual needs. Our global network of experts supports you with maintenance planning, technical support as well as operator training and end of life services. With our digital solutions, you gain control over your production processes and create transparency on product and machine data anytime, anywhere.

    Read more
    Maintenance & Support
    Maintenance & Support

    Spare Parts
    Spare Parts

    Drug product formulation downloads

    SVP brochure
    SVP brochure

    Download
    SVP Essential flyer
    SVP Essential flyer

    Download
    CV-19 capacity expansion flyer
    CV-19 capacity expansion flyer

    Download

    Our customers are also interested in

    Membrane-based pure media systems » Syntegon
    Membrane-based pure media systems » Syntegon

    We offer a modular, turn-key solution for the “cold” membrane-based generation of pharmaceutical-grade pure water (PW), high purity water (HPW), and water for injection (WFI).

    More
    Distillation-based pure media systems » Syntegon
    Distillation-based pure media systems » Syntegon

    We offer a flexible, turn-key solution for the distillation-based (i.e. thermal) generation of...

    More
    Pure media generation & distribution » Syntegon
    Pure media generation & distribution » Syntegon

    Syntegon has been supplying Pure water (PW), high purity water (HPW), water for injection (WFI),...

    More
    Glove Testing Systems – The highest safety for isolators and RABS
    Glove Testing Systems – The highest safety for isolators and RABS

    Barrier systems such as isolators or RABS play a fundamental role in the protection of people and...

    More
    Become a Pro in granulation!
    Become a Pro in granulation!

    Come join us for our OSD Academy expert seminar “Granulation – from powder to tablet” in June 2023.

    More
    More Syntegon News
    support-01

    Interested in drug product formulation solutions?

    Contact us