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Pharma Services Oral Solid Dosage

Pharma Services OSD

With the aim of supporting your research, development, and manufacturing activities, Syntegon offers a global network of pharma customer centers and partner laboratories. Based on profound knowledge and long-standing experience, an interdisciplinary team of leading scientists and process specialists supports your entire product development process – from laboratory to production.

Our expertise

OSD Customer Centers

Syntegon has four fully equipped OSD Customer Centers in Germany, China, and the U.S., as well as a global network of partner labs.

Hands-on technology

Our R&D machine portfolio covers all process steps – including mixing, granulating, drying, tablet pressing and coating, pellets manufacturing and capsule filling.

Product characterization

We provide the basics for further product development and offer ideal conditions for product test series and individual process optimizations.

Know-how

In our knowledge reports, our experienced colleagues share their expertise and explain how you can overcome challenges with APIs with our machines.

Drug and process development and optimization

Time-to-Market is crucial in today’s pharmaceutical industry. We support the complete development with our product portfolio, R&D capabilities, and pharmaceutical expertise.

Training

Our interdisciplinary experts offer you customized and efficient training on our state-of-the-art equipment.

Syntegon OSD Customer Center, Waiblingen

The Syntegon OSD Customer Center in Waiblingen offers everything you need for the formulation, development, and production of your oral solid dosage forms – from cleanrooms and assembly areas to offices, meeting and training rooms.

Syntegon – Pharma OSD services and process technologies

Syntegon covers all steps of solid pharmaceutical processing and production: from blending API with excipients, the preparation of solid formulations by granulation and particle coating, to capsule filling and tableting, as well as tablet coating.

Automated Process Development (APD)

APD is our Quality by Design (QbD) approach to determine and automatically adjust the optimal parameters for your capsule filling process. The combination of systematic planning (DoE) with automated test set-up on our GKF capsule filler is a unique and patented technology to perform many experiments swiftly, whilst optimizing yield and quality.

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Syntegon locations – Syntegon OSD Customer Centers and Partners

Syntegon has four fully equipped Customer Centers at your disposal in Schopfheim (DE), Waiblingen (DE), Hangzhou (CN) and Minneapolis (USA), as well as a global network of partner labs.

You can conveniently run through all process steps, from the production of solid dosage forms to test series for the development or advancement of your products. The laboratories are equipped for mixing, granulating, drying, tablet pressing and coating, as well as pellets manufacturing and capsule filling. We also provide hands-on assistance along the product life cycle: from complete solutions to the improvement of individual process parameters. The OSD Customer Centers provide the entire infrastructure for processing trials, whether you want to perform them yourselves or have the Syntegon pharmacists take over. We also collaborate with global partner laboratories for your fundamental feasibility studies.

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Drug and process development and optimization

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Which pharma services do we offer?


We support the complete development of your OSD form with our product portfolio, R&D capabilities and pharmaceutical expertise. Syntegon represents a century’s worth of knowledge in solid dosage formulations and equipment design, making us your qualified partner.

Formulation development

We develop formlations from batch sizes of 30 g to 10 kg and offer the following services: research publications, formulation strategy, pre-formulation studies, selection of excipients, as well as manufacturing and analyses of finished powder, granules, tablets, pellets.

Solid dosage forms
New drugs or market-driven efficiency programs require you to improve the formulation of your powder, granules, (micro-) tablets, pellets, liquids, and all their derivates. Due to the high amount of active substance in the formulation, the amount of excipients need to be minimized.

Process development and optimization for oral solid dosage production
Process safety, robustness, and efficiency are the key factors in pharmaceutical manufacturing. Based on modern scientific approaches like QbD (Quality by Design), PAT (Process Analytic Technology) and data mining, we can design and develop a technically stable and commercially efficient process.


Process optimization
  • Holistic approach for the entire production chain of all oral solid dosage forms
  • Analysis and optimization of machine and process parameters to enhance efficiency
  • Access to all current machine features (format and size parts, sensors)
  • Optimization consulting for existing processes (e.g. risk analysis, dosing process)
  • OSD customer center with current machines (features) for testing under controlled environment
  • Scale-up and product transfer (NexStep scale-up software)

R&D machine portfolio

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High-Shear Mixer


Process robustness and high efficiency are the main requirements for high-quality granulation in a high-shear mixer. Our technology is based on the unique Gentlewing impeller. The high-shear mixer granulator provides perfect mixing in short time and allows for a wide process window in terms of e.g. tip speed, filling level and mixing duration. At the same time, wall caking and product residues are minimized.

fluid-bed-dryer

Fluid bed system


Unlike other solutions, our fluid bed lines allow you to dry, granulate and coat more efficiently with just one product container. With an ideal air distribution and an efficient filter system, you can achieve maximum drying efficiency at minimum product losses. Heat transfer and drying are more homogenous and faster, with a high flexibility in batch size.

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Tablet compression


Tablets are still the most popular Oral Solid Dosage (OSD) form. However, successful drug development is challenging. At Syntegon we develop tablet presses that are ideally suited for both pharmaceutical and nutrition and health products. Our TPR series consists of tablet compression machines featuring our renowned quality and an excellent price-performance ratio. The tablet presses answer the growing need for high efficiency, easy maintenance and operation – from R&D and pilot scale to high volume production. 

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Tablet coating


Tablet coating is an important process step in tablet production. The pharmaceutical industry needs solutions that meet coloring and taste-masking requirements, as well as high demands from applications such as enteric coatings, controlled release coatings or the addition of an active ingredient. With our vast experience from the former Manesty brand, combined with Hüttlin’s strong innovation and process expertise in mixing, spraying and drying, Syntegon has created a new benchmark for tablet coating: our new Sepion tablet coater.

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Capsule filling


Our capsule filling machine series provide best conditions for highest pharmaceutical standards – from R&D and pilot scale to high production volumes. Whether you need to fill powders, (mini-) tablets, pellets, granules, liquids, or different combinations into hard shell capsules (HPMC or gelatin), we offer you the appropriate process technology for the production of both pharmaceutical and health and nutrition products. We also provide a containment concept for several machine platforms for the production of potent APIs up to OEB 4 or OEB 5, which ensure the highest operator protection.

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Capsule sealing via banding


Capsule sealing with banding technology ensures the highest product quality and prevents liquid-filled capsules from leakage. Banding also provides an additional measure for anti-counterfeiting of capsules filled with powder or other components and an enhanced safety measure to meet regulation requirements. Our Syntegon GKB 2100 banding machine can handle both hard gelatine and HPMC (plant-based) capsules. It also meets other challenges with a particularly robust and flexible process for highest yield and maximum process stability. The focus is on user-friendliness, very good accessibility for cleaning and easy format part changeovers. Our banding machine achieves an output of up to 125,000 capsules per hour.

Why Syntegon Services?

Our expertise, your advantage


A comprehensive service portfolio lays the foundation for smooth production processes. We at Syntegon support you throughout the entire machine lifecycle, from spare parts management to digital line optimization. Service agreements are a key element of our portfolio structure. We minimize production risks and maximize the efficiency of your equipment by working with you as equal partners.

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"Powerful innovation” – interview with Dr. Thomas Brinz

The new OSD Customer Center in Waiblingen, Germany has everything customers need for the formulation, development and production of their oral solid dosage forms, as Dr. Thomas Brinz, Head of the OSD Customer Center, explains in this interview. Enjoy reading it!

Know-how – learn from the experts

Cleaning of capsule filling machine
Cleaning of capsule filling machine

TPR ready for MUPS
TPR ready for MUPS

TPR 200 – robustness, stability, and high yield
TPR 200 – robustness, stability, and high yield

GKF – dosing of mini-tablets into capsules
GKF – dosing of mini-tablets into capsules

Automated Process Development (APD)
Automated Process Development (APD)

KKE – reliable empty capsule inspection
KKE – reliable empty capsule inspection

GKF 720 – manufacturing efficiency
GKF 720 – manufacturing efficiency

Waxy sticky powder
Waxy sticky powder

GKF dosing module and format change
GKF dosing module and format change

Commissioning of TPR tablet presses
Commissioning of TPR tablet presses

Tablet press feeding system
Tablet press feeding system

FDA requirement: safe, reliable and robust production (PAT classic)
FDA requirement: safe, reliable and robust production (PAT classic)