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.

Large volume parenterals

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

Line Integration

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

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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

Our industrial designers and engineers have developed the SVP/LVP process system in close cooperation with our customers with a clear common objective: achieving the greatest possible flexibility with maximal ease of operation. The result is a modular, highly flexible system. We use pre-tested functional modules to configure each customer’s individual solution. Syntegon and the customer jointly define the shape, volume, and functionality of the fixed or mobile containers, which allows us to deliver exactly the preparation system the customer needs for his products. Over 70 pre-tested functional modules are available to process batch sizes from 13 to 20,000 liters, offering unique versatility and convenience.

Benefits

maximum flexibility and ease of installation
full range of unit operations and process control
modular building set with short delivery times
particularly user-friendly and easy to maintain
full range of qualification and start-up support services available

We offer multiple options for substance addition. You can feed APIs and excipients either manually or, when handling larger amounts or critical substances, through vacuum conveyors, liquid dosing stations, or containment solutions for sterile or toxic substances. A full range of dry and liquid materials alike can be seamlessly added to all the processing vessels. Regardless of the selected options, we deliver all solutions with an “out of the box” approach.

Benefits

complete functionality for the intended range of products
all functional modules are controlled by the same automation system
pre-tested modular building set for substantial cost savings and accelerated delivery
designed in cooperation with customers for ease of use
full range of qualification and start-up support services

Solutions, suspensions, and emulsions alike, all require the right approach to mixing and homogenizing the preparation to provide the necessary product quality. The SVP/LVP offers a wide range of options including low and high shear mixers, high performance homogenizers and emulsifiers, as well as vibration mixers. Is bioburden reduction, sterile filtration, or aseptic processing required? Also not a problem with the SVP/LVP. Our integrated sterile filter stations come in a wide range of sizes, all optimized to minimize product loss.

Benefits

complete functionality for the intended range of products
all functional modules are controlled by the same automation system
pre-tested modular building set for substantial cost savings and accelerated delivery
designed in cooperation with customers for ease of use
full range of qualification and start-up support services

Benefits

fully integrated and automated systems
over 70 pretested functional modules available
program, production, and batch management sequence flexibility
automation architecture structured according to ISA-88
integrated interface to filling line with shared CIP/SIP

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.

Benefits

optimized plant layout, pipe routing, and material flow
coordinated processes and adapted alarm functions
shared CIP/SIP systems
minimal cleanroom footprint and product loss
lower capital investment and faster project execution with lower risk

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

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.

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.

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.

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

Our solutions have got you covered

Technology

Regardless of the project scope – from individual process vessels and their automation to all associated peripherals including media supply, CIP/SIP systems, and the filling line interface – our modular technology portfolio provides a complete, seamless solution for the preparation of small volume parenterals (SVP), large volume parenterals (LVP), infusion products (IV), as well as buffer and media.

Reliability

All over the world and over 30 years, our modular solutions provide everything that is required for a highly flexible yet seamlessly integrated system infrastructure.

Sustainability

Our advanced technology and modular design feature best-in-class energy efficiency throughout. Our fully integrated solutions substantially reduce both operating costs and the carbon footprint.