Microbatch | Automated Microbatch Processing

Dream big. Start small.

Meet Versynta: Precision and
flexibiliy in a compact machine.

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Producing small batches of innovative treatments such as cell and gene therapies requires high standards for efficiency and quality. The Versynta microBatch empowers you to meet these challenges head-on with award-winning technology built for precision and flexibility.

Streamline your process: The gloveless working cell embodies robotic excellence on the smallest scale. Following the trend towards even smaller batches, the highly flexible and fully automated setup allows the processing of aseptic and high-potent micro batches.
Achieve efficient results: Fast batch-to-batch changeovers, minimized product loss and a fully integrated machine and isolator are the keys to ensure quality and output.

With Syntegon, you’re investing in more than a system—you’re gaining a trusted partner backed by over 15 years of small batch expertise and more than 60 successful projects.

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Compact pharmaceutical filling machine designed to reduce production costs in small-scale manufacturing

Reduce your production costs

Small batch production is often cost-intensive due to inefficient processes and high product loss. The Versynta microBatch minimizes waste and integrates fully automated systems to reduce operational costs, making small batch production more economical.

Automated robotic system streamlining small-scale pharmaceutical production for time efficiency

Save time with rapid changeovers

Lengthy changeovers between batches can slow your production and delay critical therapies. With fast batch-to-batch changeovers, the Versynta microBatch helps you maximize production uptime and stay ahead of timelines.

Robotic arm ensuring precise handling of components in small-scale pharmaceutical production

Ensure quality at every step

Maintaining the integrity of aseptic and high-potent micro batches is essential but challenging. The Versynta microBatch combines an integrated isolator and machine design to deliver consistent, high-quality results, ensuring your products meet the highest standards every time.

Use case scenarios: Tailored applications for every need

Clinical phase drug products

Flexible production with optimized, automated processing enables a precise fill for nearly all containers or closures destined for the clinic.

Cell and gene therapies

Efficient production of high-value therapies with Syntegon’s gloveless isolators and waste-minimizing technologies for micro batches.

Biopharmaceutical liquids

Reliable, sterile production of complex biopharmaceutical liquids with Syntegon’s vial, syringe and cartridge filling systems.

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Syringes, vials and cartridges can be processed at our Versynta microBatch. Also rubber stoppers, aluminum seals and press-fit caps can be handled.

Glove ports are used to position the bag and remove waste. So the bag can be opened without any contact with the tub. This system is easily integrated into existing production line concepts.

The waste bag is placed and connected under the machine using a rapid transfer port and a heating frame is integrated into the system to minimize particle generation.

Containers, while being weighed and filled, remain in nest. Additionally, the output can be increased with statistical IPC.

Disposable racks are introduced through a rapid transfer port. Furthermore, the system offers fully automated settle plate handling.

An innovative sorting system eliminates the need for bowls. This system utilizes a camera system for picking of stoppers and caps.

The system offers a fully integrated air handling. This is achieved through a room-in/room-out concept, which simplifies room integration.

This closed system is ideal for high-potency applications. It efficiently removes rejects through a rapid transfer port and even allows for sample removal using the same rapid transfer port mechanism.

Product safety means keeping human intervention to a minimum. This is especially true for high value medicines like biopharmaceuticals produced in very small batches. For utmost protection, the Versynta microBatch includes an integrated gloveless isolator. The fully robotic working cell meets the strictest quality requirements at the smallest scale.

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Benefits

Short bio-decontamination times
Suitable for aseptic and highly potent small batches
No need for glove testing and glove management

The secure fill-finish of micro batches requires reduced operator intervention. Besides the integrated gloveless isolator, the Versynta microBatch relies on leading robotics technology to ensure reproducible processes with no manual interventions. Robots like the Syntegon Pharma Handling Unit cover key process steps such as filling and closing in a truly automated way.

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Benefits

The least possible human intervention thanks to automation
Automated filling path, format parts and monitoring set-up
Compact cell with the smallest possible footprint

The dimensions of the machine are small and can easily be integrated into existing production environments. The integrated air treatment system minimizes the need for interfaces to the building or technical ceiling installations. The new development sets new standards, particulary in terms of automation. The gloveless isolator with integrated air handling significantly reduces the risk of contamination since it eliminates manual intervention.

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Benefits

Integrated air treatment for maximum product safety
Minimum interfaces to building
No technical space required

While batch sizes tend to decrease, the variety of packaging styles remains at an all-time high. Syringes, vials, and cartridges are the most commonly used RTU containers for liquid pharmaceuticals and can all be processed on the Versynta microBatch. The system has been designed to fill and close a wide variety of glass or plastic containers. We focus on loss-free filling to enhance the quality of our customers’ micro batch filling operations.

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Benefits

Suited for all RTU containers (syringes, vials, cartridges)
Vial closing with classical stoppers, crimp caps, press-on caps
Single-use filling possible

Fast batch-to-batch changeovers, minimized product loss, a fully automated filling and 100 percent in-process control ensure continuously high quality and output.

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Benefits

No human intervention required, resulting in high product safety.

The microBatch set-up meets the highest sterility requirements as specified by Annex 1.

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Benefits

Reduction of contamination risks
No asepetic interventions by humans
Higher product safety and quality

The Versynta microBatch advantage

Compliant and future-ready design

Minimize your risk of contamination and Annex 1 compliance with seamless incorporation of gloveless isolators and integrated air management.

Reliable 12-month delivery

Stay ahead of your production goals with Syntegon’s industry-leading short delivery times, enabling faster operational readiness.

Fully automated robotic solution

Achieve optimal production output of up to 500 containers per hour with fully automated robotics and precision-engineered systems, ensuring maximum productivity.

Faster time to production

Quick and efficient bio-decontamination cycles of less than 45 minutes contribute to batch changeovers in the shortest time possible, allowing more flexibility in drug product manufacturing.

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Ready to transform your small-batch production? Connect with our expert team for personalized guidance or download the whitepaper to explore the details further.

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Pharmaceutical professional in sterile gown operating RTU equipment, showcasing Syntegon's compliance with GMP and Annex 1 global standards for safe production

Partnering with Vetter for small batch excellence

In collaboration with Vetter, Syntegon delivered advanced solutions for small-batch RTU processing, addressing the industry's evolving needs. By combining expertise and innovation, the project ensured superior aseptic quality and efficient production outcomes. This partnership showcases our commitment to supporting pharmaceutical manufacturers with tailored, high-performance solutions.

Our expertise, your advantage

Award winning design: Equipment doesn’t need to be marketed to be in the limelight: in October 2021, Syntegon received the Parenteral Drug Association’s Innovation Award for its Versynta microBatch development project. The award honours the novel approach, which is expected to set a new industry standard for small-scale filling processes. Read the press release to find a more.

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Klaus Ullherr, Senior Product Manager at Syntegon

Implementation of the new Annex 1

"Our Versynta portfolio follows a clear market trend: smaller batches for new innovative medicine. Versynta microBatch meets the highest sterility requirements as specified by Annex 1 and can process nearly all RTU containers.”

Klaus Ullherr, Senior Product Manager at Syntegon

FAQs: Reliable small batch production solutions

Our aftersales services are designed to maximize uptime and performance. This includes customized service agreements for regular maintenance, rapid parts replacement, and technical support tailored to your specific setup. Performance improvement audits help identify inefficiencies and optimize operations, ensuring your system remains cutting-edge even as technology advances.

Additionally, modernization services allow you to upgrade components as industry standards evolve, so your investment stays relevant for years to come.

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Regulatory shifts are a constant concern for pharmaceutical manufacturers. With Syntegon, you gain a partner that stays ahead of industry updates. Our compliance services not only ensure your system is fully aligned with Annex 1 requirements but also provide ongoing support for validation and requalification as standards evolve.

We also offer detailed documentation and expert audits to keep you prepared for inspections, helping you navigate even the most complex compliance landscapes with confidence.

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Production interruptions can cost time and money. That’s why we prioritize proactive maintenance and rapid response times. Our parts inventory is designed to minimize delays, with quick access to critical components for repairs.

Additionally, digital solutions provide live monitoring of your equipment performance, enabling sustainability monitoring and support in reducing unplanned downtime.

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From day one, our expert teams are with you. We provide on-site installation support, comprehensive training programs for your staff, and operational guidance to ensure a smooth start. Once your system is running, you can rely on our technical support team for troubleshooting and ongoing assistance.

We also support you with refresher trainings during the whole lifecycle of your equipment.

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Absolutely. The Versynta microBatch is built with scalability and flexibility in mind. Whether you're expanding capacity, switching to different container types, or incorporating new processes, the system’s modular design can adapt without requiring a full overhaul.

Combined with our modernization and upgrade services, you’ll always have the ability to evolve alongside your market’s demands.

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Ensuring product quality is a priority for any pharmaceutical manufacturer. The Versynta microBatch is equipped with integrated in-process controls and advanced sensors to monitor quality at every stage. These features ensure batch-to-batch consistency, reducing waste and safeguarding your brand’s reputation.

Our quality assurance services, including validation and qualification, further guarantee that your system is performing to the highest standards, even as production demands shift.

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Small batch manufacturing often faces challenges like high costs, tight timelines, and complex processes. The Versynta microBatch addresses these with efficient automation, fast changeovers, and minimized product loss.

To further support small batch manufacturers, our pharma services include tailored process optimization and technical audits, ensuring your operations remain efficient and profitable.

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With Syntegon, you’re investing in more than a system—you’re gaining a trusted partner backed by over 15 years of small batch expertise and more than 60 successful projects. From tailored services to expert maintenance, we ensure your production remains future-ready.

Connect with our experts or explore our service portfolio below.

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