Pharma

Solid.
Mixing. Drying. Granulating. Coating.
Capsule filling. Tablet compression.
5.800 66.000
Global megatrends in
the pharmaceutical industry
employees machines in the installed base

Global population is growing by 80 million people per year.

Count
on it. 30locations
160 years of experience 01 Innovation and
patient focus

1.4 billion
06 Demographic 02 Safety
change

euros annual sales

05 Access to 03 Sustainability

1.100 1.800
pharmaceuticals

04 Digitization

service specialists patented inventions

01 02

Change in development pipelines: Production of pharmaceuticals according

faster cycles with more products and less to highest safety standards in a changing
blockbuster for smaller patient groups, environment and increasing demands
higher demand for individualized medicines

03 04
Syntegon Technology is your reliable partner for process and packaging materials. In the food industry, we offer solutions
packaging technology in the global pharmaceutical and food for the primary and secondary packaging of dry, liquid and Growing importance of efficient resource New therapies for chronic diseases,
industries. Whether you are an aspiring start-up or a global frozen food as well as process technology for the production usage, decrease waste and spoilage more patient data, I 4.0 solutions,
market leader, we offer intelligent and sustainable solutions of confectionery. digital protocols for batches
for everyone.

Individual machines, systems or services – as a full-service We are at your side from project planning, development and 05 06
provider, we take responsibility right up to fully integrated end- implementation to comprehensive digitization, qualification
to-end solutions. Fields of application in the pharmaceutical and validation services. In addition, you always have access to Rising demand for cost-effective medicines Increasing life expectancy, growing
industry are the production, processing, filling, inspection and our worldwide network of service specialists who support you in an increasingly competitive environment number of older people, higher demand
packaging of liquid and solid active ingredients in all common throughout the entire machine life cycle. for medication

2 3
Welcome to Pharma Solid Mixing, drying and granulating
All processes and services from a single source High-shear mixer granulator technology

Pharma line competence for solid dosage forms

Drying, granulating Tablet

• Hüttlin high-shear mixer technology is available

••
and pellet coating coating with either top or bottom drive granulators
Batches up 720 kg at a density of 0.5 kg/l
The innovative Gentlewing agitator offers the
flexibility to use 20 - 80 % of the gross volume and

••
minimizes the residues
A metal filter offers high safety during charging
Purged shaft seals and an inflatable seal at the

•
lead guarantee a closed process
The load of the wet mill adjusts the speed of the
impeller and enables a maximum discharge without

•
blockage of the mill
The high-shear mixer can also be equipped with a

•
standard 3-blade agitator
For special products as effervescent, e.g.,
Capsule Tablet Single Pot versions are available
filling compression

HTG
Hüttlin top drive granulator
HBG
Hüttlin bottom drive granulator

Continuous manufacturing
We provide Pharma Services in our four OSD Customer
Centers in Wablingen (Germany), Schopfheim (Germany),
Hangzhou (China) and Minneapolis (USA) as well as in partner
labs around the world. Our services amongst others include
hands-on technology, product characterization support, drug
and process development, process optimization and trainings.

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Mixing, drying and granulating Drying, granulating
and pellet coating
High-shear mixer Single Pot
The Single Pot version of the Hüttlin high-shear mixer
granulator combines all of the benefits of the top drive
concept with the specific features as e.g SmartFlow,
heating jacket, product temperature regulation and
vacuum drying with solvent recovery.

HD
Hüttlin Dryer

1 Heated product container

HDG
2 Heated impeller shaft Hüttlin Dryer Granulator
3 Heated lid
HDGC
4 SmartFlow, 360° strip gas feeding Hüttlin Dryer Granulator Coater
5 Discharge valve
6 Gentlewing
7 Chopper
8 Temperature measurement
9 Cleaning nozzles
10 Filter
11 Vacuum pump
12 Condensation unit
13 Video camera

10 13

12 11 3
9 9

2
1
• The Hüttlin fluid bed technology provides drying, granulating and coating in

•
one product container for batch sizes of up to more than 1,600 kg
Unique air distribution plate Diskjet guarantees very efficient mixing and drying
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••
due to a high velocity of process air
Hüttlin bottom-spray system reduces process times significantly
3-component nozzles ensure long operation times without interruption, as the

••
tip of the nozzels are protected by Microclimate
Process filter system operates with a sequential blow back
6
••
Ultra Clean metal filters available
Pressure shock resistant design is standard
Scale-up software NexStep ensures a successful scale-up
4 5 4

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R&D equipment R&D equipment
Mycromix FlexiTab XL*

• This table-top device can be equipped with inter­ Single punch tablet press

•
changeable bowls from 0.5 to 10 l Capable of manufacturing single, two and three layer tablets
Each of the bottom driven bowls is equipped with for R&D and clinical trial materials (operation non GMP or GMP

••
our unique Gentlewing agitator compliant)
Vertical chopper is inserted into the lid
Output

••
The Mycromix can be upgraded for the use of

•
organic solvents 1 Layer: 900 tablets/h

•
All process parameters can be set by the integrated HMI 2 Layer: 600 tablets/h
3 Layer: 300 tablets/h

Flexibility
Different modes of operation allow the formulation
development scientists to manually or automatically
sequence tablet production

Solidlab 1 Product development

Single punch machine that enables the initial screening

• The table top unit Solidlab 1 can be equipped either with

of powders and granules for subsequent product
development

•
a fluid bed, or a drum coater process module
Based on two exchangeable drum sizes, the Solidlab 1
Standard punches and dies

•
drum coater processes batch sizes from 0.2 to 1.2 kg
Ability to use standard TSM/Euro B/D punches and dies
The fluid bed module can be equipped with two different * In cooperation with Röltgen, Germany

•
product containers for batches from 0.05 to 1 kg
The common control system for fluid bed and drum
GKF 60
•
coater facilitates the work significantly
This unit supports you in developing your products and in
examining your recipes. All important parameters and
New R&D capsule filling machine
results are recorded by software. This makes the
Platform with highest flexibility and various operator protection
Solidlab 1 the ideal solution for your feasibility studies
concepts (containment) and a clear focus on PAT and QC
technologies

Flexibility
Solidlab 2 Three individual dosages possible (fixed dose combinations)

• The Solidlab 2 Plus is the only fluid bed solution available

on the market for the development of both batch and con-
PAT Technology
Gravimetric 100 % net weighing of each dosed component

•
tinuous manufacturing processes
Fast scale-up from lab to batch-production volume without
Cabin options

•
intermediate steps
Combined with the feeder-blender-unit the Solidlab 2 Plus • OEB 4 containment with open aperture and air exhaust (no

•
gloves, air exhaust unit with H14 filter installed separately)
becomes the Xelum R&D for continuous manufacturing –
OEB5 with gloves and controlled/monitored vacuum

•
no scale-up required (see page 18)
The fluid bed module can process up to 12 kg and minimal
Small foot print

•• •
250 g (density 0.5 kg/l)
Containment and automated cleaning for operator safety (approx. W 1.0 m x D 0.9 m x H 1.9 m)
The Solidlab 2 technology allows either the use of a fluid Fully automatic capsule handling, up to 60 capsules/minute
bed or a drum coater module which share one air handling

•
and control system
Cleaning
The Solidlab 2 drum coater module is equipped with
Wetting (OEB 4) or WIP (OEB 5), focus on avoidance of cross
exchangeable drums and handles batch sizes from 0.8 to
contamination
12.8 kg (density 0.8 kg/l)

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Containment solutions Capsule dosing and
tablet compression
Containment is all about the OEL Toxicity Characteristics OEB CAT.
safety of the operator. Only a Capsule dosing
Extremely high pharmacological and toxic

•
< 0.1 µg/m³ 6 G5
combination of modern and highly efffects
Capsule filling machines for powder, pellets,
efficient systems with automated 0.1 – 1 µg/m³
Very high pharmacological and toxic
5 G4 (micro-) tablets, liquids and combination fillings

•
effects
cleaning and proven processes Manufacturing quality control through the capacitive
High pharmacological and toxic
1 – 10 µg/m³ 4 G 3b sensor NWDS (Net Weight Detection System),
form the basis for successful effects
PAT Classic (Process Analytical Technology) and
containment. 10 – 100 µg/m³
Medium pharmacological and toxic
3 G 3a counting systems for tablets

•
effects
Modular and flexible machine design

•
100 – 1000 µg/m³ Low pharmacological and toxic effects 2 G2
Integrated IPC control system (gravimetrical scale)

Al depends on the limit value

1000 – 5000 µg/m³
Very low pharmacological and toxic
1 G1
• Automatic high-precision capsule checkweighing

•
effects
Various operator protection concepts (up to OEB 5)

By means of NOEL (No Observed Effect Level) and the required safety factors, the Occupational Exposure Limit (OEL) can
be determined in micrograms per cubic meter for active substances. The OEL is the time-weighted average concentration of a
substance in the air at the workplace at which no acute or chronic damage to the health of employees is to be expected.

Tablet compression

• Modular 2 or 3 paddle feeder for various powder

characteristics facilitates perfect powder distribution

• Data Acquisition System (DAQ) available to see

pre-compression, main compression, punch tightness,
ejection force and punch displacement

• Integrated die plate (higher capacity, improved yields,

faster cleaning)

• Counting (number of tablets)

• WHT (weight, hardness, thickness)

The path to safe containment Compliance with the limit values

• Same compression roller diameter and same software
package on all TPRs guarantee a safe scale-up

• Modular system with different technical containment

•• SMEPAC test during SAT • Robust design with a closed rigid compression frame and
cast iron body

• •
solutions, e.g. split valves and safe change filters According to ISPE Assessing the Particulate Containment

••
Right selection to completely fulfill the containment Performance of Pharmaceutical Equipment 120° accessibility due to swing open compression rolls

•
requirements Operator training
Assessment of real operator intake (ROI) in consideration Regular maintenance ensures the compliance with limit

•
of API, dilution and volatility values
Perfect balance from a safety and economic point of view

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Capsule dosing Capsule dosing

GKF 60 GKF 2600

R&D capsule filling machine for R&D, FIM studies, High speed capsule filling machine
clinical research phase I & II Compact and highly flexible platform for medium
Focus on integrated inspection technology and highly flexible and large batch production. Versatile dosing technologies,
dosing combinations as well as vibration dosing. quality control and state-of-the-art PAT technologies.

• Output: 3,600 caps/h

• Output:
Powder/pellets up to 150,000 caps/h
Liquid up to 120,000 caps/h

GKF 702
Low speed capsule filling machine
Lab applications, clinical trial materials and scale-up to
GKF Containment Series
small batch production. High level operator protection and washable
containment for products up to OEB 5
• Output:
Powder/pellets 3,000 - 42,000 caps/h
•• GKF 60 ProTect (OEB 4) I GKF 60 HiProTect (OEB 5)

•
Liquid up to 35,000 caps/h GKF 720 ProTect (OEB 4) | GKF 2600 ProTect (OEB 4)
GKF 1700 HiProTect (OEB 5) | GKF 720 HiProTect (OEB 5)

GKF 720
Low speed capsule filling machine
Compact and highly flexible platform for R&D and small batch Capsylon Series
production. State-of-the-art PAT technologies and Automated
GKF technology “design to cost”
Process Development based on DoE.
Ideal for the capsule filling of health and nutrition

• Output:
products.
Powder/pellets 3,000 - 43,500 caps/h
Liquid up to 35,000 caps/h •• GKF 705 Output up to 42,000 caps/h

••
GKF 1505 Output up to 92,400 caps/h
GKF 3005 Output up to 176,400 caps/h
GKF 6005 Output up to 360,000 caps/h
GKF 1400
Medium speed capsule filling machine
Compact and flexible platform for medium batch production.
KKE
• Output:
Powder/pellets up to 84,000 caps/h
Syntegon capsule checkweigher
Ideal for the high-precision capsule checkweighing.

••
Liquid up to 70,000 caps/h
KKE 1700 Output up to 103,200 caps/h

•
KKE 2500 Output up to 154,800 caps/h
KKE 3800 Output up to 232,000 caps/h

GKF 2500
High performance capsule filling machine
Compact and flexible platform for medium and large batch production.
GKB 2100
Hard capsule sealing machine via banding
• Output:
Powder/pellets up to 150,000 caps/h
technology
Suitable for both hard gelatin and HPMC (plant-based) capsules

•
Liquid up to 120,000 caps/h
GKB 2100 Output up to 125,000 caps/h

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Tablet compression Tablet compression
From formulation development to small batch manufacturing TPR 500

High productivity and quality tablet press

TPR 200 Medium to large production batches on a small footprint

Highly efficient tablet press

• Output: Up to 403,200 tablets/h

•
Compact and economic, ideal for pilot to mid-size production
batches, for single or double layer tablets Modularity: Modular 2 or 3 paddle feeder with interchangeable

•
paddles, extended filling length & drive options

•
Output: Up to 230,400 tablets/h

•
Fast changeover: Quick and simple turret removal with
Modularity: Modular and interchangeable 2 or 3 paddle integrated crane system

•
feeder with centrally or individually controlled paddle
speeds together with a choice of rectangular or round Flexibility: High flexibility with a precisely adjustable and
paddle blades, simple and repeatable setup modular powder feeding system

• Fast product changeovers: The hygienic design with

exchangeable turret offers increased flexibility of tablet
• Usability: Exceptional usability through intuitive HMI and
state-of-the-art control (separate and movable or cantilevered
sizes on the same machine attached to the TPR)

• State-of-the-art: Off the shelf Beckhoff control linked with

our latest HMI operating software
• Hygienic design: Outstanding hygienic design with two level
production zone: easy access, less cleaning

TPR 200 Plus

TPR 700
New industrial machine design
Upgraded TPR 200 with new additional features, ideal for Fully automated double sided tablet press
R&D, clinical and small/medium batch production, for single High volume output for single or double layer tablets

•
or double layer tablets

•
Output: Up to 1,008,000 tablets/h (single layer tablet)

•
Output: Up to 230,400 tablets/h

•
Modularity: Modular 2 or 3 paddle feeder with interchangeable
Containment: Light Containment concept for operator paddles

•
protection up to OEB 3, with glove port access, dry cleaning
possibility and turret design for external wash-down Fast changeover: Quick and simple turret removal with

•
integrated crane system

•
Optimized media and electrical cabinet: Clear separation
of process connection and electrical components for better Diverse: Suited for a wide range of compressible products
dust tightness including non-pharmaceutical materials

• APD feeder for automated process development: An

automated systematic approach to find the most suitable
• Usability: Exceptional usability through intuitive HMI and
state-of-the-art control (separate and moveable or embedded
production parameters in the formulation development of in GMP room)

•
OSD forms (esp. tablets): to determine the optimal manufac-
turing parameters for a specific product, to ensure quality Mobility: Air cushion available for improved mobility of the
and minimize product loss. press

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Containment solutions Tablet coating
Capsule filling and tablet compression
Since Sepion is designed for closed charging,
sampling and discharging, a containment
upgrade for coating of tablets with highly
potent active ingredients is facilitated.

An extended drum length provides a shallower

tablet bed, but also space for an increased
number of spray guns. The combination of both
enables high spray rates and shorter process
times.

GKF 720 or 1700 containment with peripheral equipment

• Flexibility in batch size varying from 10 % to 100 %

• Mixing uniformity in < 8 min

High level operator protection and washable containment • Fast charging and discharging

•• Equipment for handling products up to OEB 5 requirements

• Automated spray arm adjustment with gun-to-bed
distance measurement
Modular design provides dosing flexibility for specific applications
• Short process times due to high spray rates and

••
(even fixed dose combinations)
effective drying

•
Automated cleaning system provides processes which can be validated
Integrated gravimetrical weighing for in process quality control, can be Very low RSD (Relative Standard Deviation) of
combined with an inbuilt 100 % net weight control or a separate applied coating

••
100 % cross-weight control
• Closed material handling

•
Integrated gloves ensure best access for troubleshooting and cleaning
Suction nozzle for manual pre-cleaning reduces amount of Streamlined containment upgrade

••
contaminated cleaning water
• Completely 21 CFR Part 11 compliant

•
Washing in Place (WIP)

••
Air inlet filter HEPA H13/H14 Recipe controlled cleaning system
Special exhaust system with HEPA H13/H14 filter
• Available in six sizes from 175 to 1,000 l

••
Safe exchange of filters and gloves
Inflatable seals on machine doors

•
RTP (Rapid Transfer Port) for tool and part transfer
Sophisticated sampling strategy via gates

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Xelum Innovative services
Your shortest way to continuous manufacturing
tailored to your needs.
A comprehensive service portfolio lays the foundation Our global network of experts supports you with maintenance
In continuous manufacturing, the processes take place successively without interruption while
for smooth production processes. We at Syntegon support planning, technical support, and modernizations, as well
the product is charged and discharged simultaneously. The main challenge is the precise dosing you throughout the entire machine life cycle, from spare as operator training and expert services. With our digital
parts management to digital line optimization. Service solutions, you gain control over your production processes and
of the starting materials in a constant mass flow rate of milligrams per second. Syntegon has a
agreements are a key element of our portfolio structure. create transparency on product and machine data – anytime,
different approach. We minimize production risks and maximize the efficiency anywhere. Whether it is switching to sustainable materials
of your equipment by working with you as equal partners. or upgrading to automated technologies, together with us you
will take the next steps towards the factory of the future.
The Xelum platform doses active ingredients and excipients as discrete masses and not as a Together, we tailor our solutions to your individual needs.
You benefit from fixed conditions and guaranteed services. How can we help you? Please get in touch with us:
continual mass flow. The system doses, mixes and granulates individual packages, so-called
www.syntegon.com/services
X-keys, which continuously run through the process chain and are discharged successively as
granules, tablets or capsules. This way, even smallest amounts of APIs of less than 1 % can be
dosed precisely.

•• Smart control strategy

••
APIs of less than 1 % can be dosed precisely
Granules with superior characteristics due to fluid bed granulation

••
Unimodal particle size distribution
No transfers of wet granules

••
No scale-up, direct transfer of process parameters
Software support for DoE

••
Traceability based on X-key principle
Minimized start-up and shut-down losses

••
Good cleanability
Production scale: nominal capacity 30 kg/h
Xelum R&D: minimum amount of product 250 g, maximum rate 10 kg/h enables also pilot production

Xelum R&D consisting of the feeder-blender-unit Xelum production unit

and the Solidlab 2 Plus fluid bed

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Connect
with our team.

© Syntegon Group | PADH | 04.2023 | subject to change

Syntegon Technology GmbH Hüttlin GmbH - A Syntegon Company

Stuttgarter Straße 130 Hohe-Flum-Straße 42
71332 Waiblingen, Germany 79650 Schopfheim, Germany

Mail [email protected] Mail [email protected]

Phone +49 7151 14-0 Phone +49 7622 6884-0
Web syntegon.com Web syntegon.com