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    Operator in cleanroom suit supervising Syntegon SVP pharmaceutical formulation system with stainless steel vessels, piping and automation interface.

    Pharmaceutical formulation and bioprocessing for GMP scale

    Handle shifting batch sizes and strict sterile requirements with modular formulation and bioprocessing systems 

    Connect with our experts Explore downloads

    De-risk pharmaceutical formulation projects from clinical to commercial scale

    Pharmaceutical formulation and bioprocessing must deliver SVP, LVP, buffers and media across shifting products and batch sizes. Syntegon combines modular systems, automation and lifecycle services so you manage rising complexity, support GMP needs and scale capacity with confidence

    Pharmaceutical formulation: flexible batches, modular rooms, clear interfaces

    How to handle shifting batch sizes in pharmaceutical formulation?

    Rely on Syntegon modular SVP and LVP systems to match any batch size.

    How to minimize product loss in automated bioprocessing?

    Leverage Syntegon automation and filtration to protect high value product.

    How to ensure safe, integrated pharmaceutical formulation lines?

    Use Syntegon modular platforms with CIP/SIP and full line integration support.

    See how formulation and filling systems work together in one line

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    CIP/SIP media supply for clean utilities

    Supply PW, WFI, pure steam and cleaning solutions so formulation and filling skids stay ready for validated use.

    Formulation systems that protect product

    Prepare SVP and LVP batches in modular vessels with controlled mixing and temperature to support GMP-focused product quality.

    Filter skid for sterile filtration control

    Perform pre and sterile filtration on a dedicated skid that limits product loss, eases qualification and simplifies routine service.

    Filter integrity testing that supports Annex 1

    Run automated filter integrity tests with full audit trails so you document critical steps and support Annex 1 focused control.
    Filter test

    Aseptic filling cell for sterile containers

    Fill vials, syringes and cartridges in an aseptic core that minimizes interventions and links directly to the formulation area.

    Freeze drying for sensitive parenterals

    Lyophilize temperature-sensitive parenterals in a unit that connects to the filling line for controlled loading and unloading.

    COP/SOP cleaning for reusable parts

    Clean and sterilize components in COP/SOP units so your aseptic line starts each batch with prepared, documented parts.
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    CIP/SIP media supply for clean utilities

    Supply PW, WFI, pure steam and cleaning solutions so formulation and filling skids stay ready for validated use.
    05_Filling_&_Formulation_no_Text

    Formulation systems that protect product

    Prepare SVP and LVP batches in modular vessels with controlled mixing and temperature to support GMP-focused product quality.
    05_Filling_&_Formulation_no_Text

    Filter skid for sterile filtration control

    Perform pre and sterile filtration on a dedicated skid that limits product loss, eases qualification and simplifies routine service.
    05_Filling_&_Formulation_no_Text

    Filter integrity testing that supports Annex 1

    Run automated filter integrity tests with full audit trails so you document critical steps and support Annex 1 focused control.
    Filter test
    05_Filling_&_Formulation_no_Text

    Aseptic filling cell for sterile containers

    Fill vials, syringes and cartridges in an aseptic core that minimizes interventions and links directly to the formulation area.
    05_Filling_&_Formulation_no_Text

    Freeze drying for sensitive parenterals

    Lyophilize temperature-sensitive parenterals in a unit that connects to the filling line for controlled loading and unloading.
    05_Filling_&_Formulation_no_Text

    COP/SOP cleaning for reusable parts

    Clean and sterilize components in COP/SOP units so your aseptic line starts each batch with prepared, documented parts.

    Explore our integrated formulation solutions

    CIP/SIP media supply
    Formulation
    Filter skid
    Filter integrity testing
    Filling cell
    Freeze drying
    COP/SOP

    Find the right formulation system for you

    Overall 6 Solutions
    Application focus
    Main process steps
    System type & modularity
    Typical products
    Benefits
    Syntegon SVP pharmaceutical formulation skid for small volume parenterals with integrated cleanroom wall
    SVP Systems
    Application focus
    Formulation of liquid pharmaceuticals
    Main process steps
    Comprehensive formulation/preparation, filtration, and storage with integrated CIP/SIP
    System type & modularity
    Platform based on 40 pre-tested modules
    Typical products
    Injection solution, suspensions, emulsions, antidiabetic & obesity drugs, ADCs, vaccines
    Benefits

    Best if you want:

    • Configurable SVP formulation
    • Automated recipes and process control
    • Compact design and ease of installation
    • Easy maintenance

    Syntegon LVP formulation system with large stainless steel tanks and platform for large volume parenteral production
    LVP Systems
    Application focus
    Formulation of LVP and buffer preparations
    Main process steps
    Buffering, media prep, bulk formulation & filtration, storage
    System type & modularity
    Platform based on pre-tested modules
    Typical products
    Buffer solutions, electrolytes & glucose solutions, parenteral nutrition & sirups
    Benefits

    Best if you want:

    • Optimized processes and flexible layouts
    • Outstanding ingredient handling solutions
    • OEE‑optimized workflows from production to fill-finish

    07_FPP_beige
    FPP Systems
    Application focus
    Formulation of liquid pharmaceuticals
    Main process steps
    Buffering, media prep, formulation & filtration, storage
    System type & modularity
    Family of fully flexible mobile equipment
    Typical products
    Suspensions, emulsions, antidiabetic & obesity drugs, dental injection solution, ADCs, vaccines.
    Benefits

    Best if you want:

    • Mobile equipment with MTP automation system
    • Easy multiplication of skids
    • Single-use compatibility
    • CTO or ETO platforms according to your needs, taking advantage of modularized design 
    Syntegon CIP system with mobile tanks for automated cleaning of pharmaceutical formulation equipment
    CIP/SIP-Systems
    Application focus
    Integrated or external cleaning and sterilization
    Main process steps
    PW, WFI, PS & application-specific cleaning and sterilization
    System type & modularity
    Mobile or building integrated CIP/SIP-systems
    Typical products
    Benefits

    Best if you want:

    • Complete level of automation and reproducibility
    • Efficient use of cleaning media through recirculation
    • Safe & validated cleaning processes 
    Syntegon Modular Bioprocessing Platform with multiple stainless steel bioreactors and integrated skid
    Modular Bioprocessing Platform
    Application focus
    Clinical & commercial fermenters/bioreactors
    Main process steps
    Media prep, seed & production fermentation, harvest & purification, storage
    System type & modularity
    Modular upstream and downstream production
    Typical products
    Microbial protein & plasmid DNA products
    Benefits

    Best if you want:

    • Integrated, modular microbial bioprocessing
    • ETO or CTO platforms 
    • Fully integrated and automated systems at all scales
    11_ETO_produkt_6_-1
    Blood Plasma Processing
    Application focus
    Blood plasma fractionation
    Main process steps
    Pooling & thawing, basic fractionation, albumin fraction/IGG, virus inactivation & final purification
    System type & modularity
    Custom skids with buffer and CIP/SIP
    Typical products
    Albumin, immunoglobulin, further blood plasma products
    Benefits

    Best if you want:

    • Both custom and modular solutions to cover the entire production chain
    • Efficient engineering of highly customized processing steps

    Blood plasma guide
    Featured_Download_Teaser_formulation

    Design flexible formulation lines with one modular platform

    Get practical guidance on configuring modular SVP formulation systems.

    • Key module and layout choices
    • Batch size and recipe ranges
    • Integration, CIP/SIP and services
    Download brochure

    Formulation systems that standardize SVP, FPP and filter testing

    Syntegon SVP modular formulation system with multiple stainless steel vessels for 50 to 1000 L small volume batches.

    50 to 1000 L SVP batches on one modular system

    Run GMP SVP batches from 50 to 1000 L on one modular system for new or modernization projects.
    13_Flexible Process Platform

    Parallel production and cleaning with Flexible Process Platform

    Run formulation and COP/SOP cleaning in parallel on FPP to reduce cleanroom use and operational risk
    Mobile Syntegon filter integrity test unit with four automated tests connected to a formulation vessel in a sterile formulation line.

    Four automated filter tests for sterile formulation lines

    Automate bubble point, WIT, pressure hold and leak tests and generate traceable electronic reports.
    Syntegon formulation and filling line with highlighted 150 and 600 L tanks and operator, shown in Janssen Vaccines capacity expansion case study.
    Case Study

    Janssen Vaccines gains flexible filling and higher output

    To transfer EU processes to Korea, Janssen Vaccines worked with Syntegon to add 600 and 150 L tanks, adjust batch sizes and increase output per shift.

    value-icon-innovative-technologies
    Innovative Technologies We enable market leadership.
    Read the full story
    janssen

    Thanks to the immediate intervention by the Syntegon service team, we were 
    able to keep production running – and much more.

    Hae Eun Jeong | Project Engineer at Janssen

    Your strategic lifecycle partner for pharmaceutical formulation

    17_Ready_for_everything
    Ready for everything – from start to routine

    From installation to optimization, Syntegon supports you with structured service packages, training, and specialists – for safe, stable, and resilient production across the lifecycle.

    Learn more
    Gloved operator drawing liquid from a stainless steel pharmaceutical vessel, illustrating routine checks and maintenance for reliable formulation.
    Secure availability – every day

    Fast spare parts, qualified support, and preventive maintenance help you avoid unplanned downtime, protect performance, and keep daily operations reliable.

    Learn more
    Two engineers discussing in a production environment, symbolizing consulting, retrofits and data services for future‑ready formulation lines.
    Make your line fit for tomorrow

    Scalable retrofits and data solutions help you adapt to new demands, improve OEE, and keep your lines future-proof across changing requirements.

    Learn more

    Pharmaceutical formulation and bioprocessing download hub

    Nordmark case study for GMP filtration upgrades
    Nordmark case study for GMP filtration upgrades

    See how Nordmark upgraded collagenase filtration with a tailored GMP system. Learn how early planning and fast qualification reduced project risk.

    Download
    Flyer for Annex 1 filter integrity testing
    Flyer for Annex 1 filter integrity testing

    Review test methods, CFR Part 11 readiness and model options for plant integration. Use it to compare embedded and mobile setups.

    Download
    Blood plasma guide for fractionation planning
    Blood plasma guide for fractionation planning

    See key plasma fractionation steps, system modules and integration options. Learn how Syntegon covers thawing, purification, formulation and CIP/SIP.

    Download

    Frequently asked questions

    Parenteral pharmaceutical formulation turns an active pharmaceutical ingredient into a sterile injectable medicine by dissolving, mixing and filtering it under controlled, germ free conditions. Syntegon SVP and LVP systems provide vessels, mixers, sterile filters and integrated CIP and SIP loops as modular building blocks for this process.

    Yes. SVP and LVP platforms use standardized functional modules that we combine for your dosage form, recipe and batch size. You can process small and large volume parenteral, buffers and media in flexible vessel configurations from small clinical to large commercial batches.

    The automation architecture follows ISA 88 and is a core element of our modular concept. Recipes can run as program, production or batch sequences, which gives high flexibility in monitoring and control.

    Mechanics, electronics and software work as mechatronic modules, so changes or extensions remain manageable over the lifecycle.

    Download portfolio overview

    Syntegon covers pure media generation, SVP and LVP formulation, CIP and SIP, pure steam and final filling in one portfolio. We design plant layout, piping and interfaces together, using pretested connections and harmonized HMIs. This reduces project risk and supports consistent data flow from utilities to filling.

    Find out more

    The Flexible Process Platform separates time intensive cleaning and sterilizing from formulation on a dedicated COP and SOP skid and uses mobile vessels and filter skids. Parallel production and cleaning become possible and intelligent modules and interfaces help reduce failure risk in Annex 1 focused setups.

    Syntegon offers integrated Filter Integrity Test modules and performance skids that are Annex 1 focused and PUPSIT capable. They run Bubble Point, Water Intrusion, Pressure Hold and Leak Tests in automated sequences with audit trails, which reduces manual work and supports data integrity for sterile filtration.

    Syntegon and Pharmatec provide modular GMP fermentation skids and a modular bioprocessing platform for clinical and commercial production.

    Pre configured systems with 100 to 1,000 liter fermenters and integrated upstream and downstream steps support fast scale up and automated operation for cell culture, harvesting and purification.

    SVP, LVP and bioprocessing systems use modular hardware, optimized piping and integrated filtration to minimize hold up volumes and product loss.

    CIP and SIP recirculation, efficient cleaning media usage and energy optimized pure steam upgrades help lower operating costs and reduce the carbon footprint of formulation plants.

    Syntegon service includes inspection, maintenance, calibration, field service and requalification for pure media and formulation equipment.

    Teams provide troubleshooting, spare parts planning and upgrades such as HMI modernization. Tailored operator training sessions help your staff run and maintain SVP, LVP and utilities safely and efficiently.

    Interested in formulation?

    Interested in formulation?

     Speak with a Syntegon expert to learn more about formulation solutions. 

    Learn more

    News

    Tackling diabetes and obesity together
    Tackling diabetes and obesity together

    Discover seamless solutions for diabetes and obesity treatment with GLP-1 therapies. We support your needs from processing to assembly and inspection.

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    Smooth capsule, tablet, and gummy supplement production
    Smooth capsule, tablet, and gummy supplement production

    Discover starchless production solutions for functional gummies, enabling precise depositing, consistent quality, and efficient nutraceutical manufacturing.

    Learn more
    8 high-potent ADC vial filling lines for customers in China
    8 high-potent ADC vial filling lines for customers in China

    Discover how Syntegon delivered 8 high-potent ADC vial filling lines in China, supporting fast, high-quality pharma production.

    Learn more