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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

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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.

formulation-solutions
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

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.

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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.

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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.

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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 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.

Expert Services
Expert Services

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, and modernizations, 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.

Maintenance & Support
Maintenance & Support

Spare Parts
Spare Parts

Drug product formulation downloads

SVP brochure
SVP brochure

SVP Essential flyer
SVP Essential flyer

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

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