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Innovative Technologies for Smarter Processes.

Corporate Image


Our mission

visiotec GmbH is a subsidiary company of the Uhlmann Group and within the group the Center of Excellence for Process Optimization. Originally founded in 2000, the company was successfully providing process automation solutions solely for the pharmaceutical industry.

With dedicated focus on one thing: What can we do to support our customers in improving processes regarding PRODUCTIVITY, SAFETY and QUALITY at full production speed?

In 2013, the company re-organized by expanding its footprint to also provide the proven

visiotec solutions to the Food and Consumer manufacturing /packaging industry.

Innovative Technologies for Smarter Processes. Supporting our Customers to Succeed.

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Who we are

visiotec Team visiotec Headquarters in Laupheim, Germany



All around our customer: Our competences at work for you

Provide the Solution to You

Listen to You & Understand

Challenge

Expert Knowledge

Innovation & Technology



Industries

visio|pharma Process monitoring and optimization solutions from drug product manufacturing down to the packaging line.

visio|food Our innovative pharma solution portfolio also at work for food products and food processing applications.

visio|consumer Smart solutions for the manufacturing and packaging of Consumer Packaged Goods (non-food) processes.



Industries






Solutions

VisioScan FormChecker VisioAMV

VisioCount VisioNIR VisioLeak



Solutions





Receiver

Out of spec: 2 pinholes

Transmitter (IR light source)

Formed aluminum blister cavity or tray

Pinhole size in microns

Machine index

10

20

30

40

50

0

Threshold



VisioScan – Material inspection system Why? Applications and Benefits: • Pinhole inspection for aluminum forming and lidding

materials (e.g. blister or tray packaging processes) • Pinhole inspection of pouch materials • Pinhole inspection of tubular material (e.g. pipes)

Barrier function of package Tightness of material Integrity of material

Pinhole inspection system for aluminum forming & lidding materials based on IR (Infrared) light transmission



VisioScan – Application examples

Pinhole inspection system VisioScan for aluminum forming material installed on an Uhlmann blister machine

Pinhole inspection system VisioScan for aluminum lidding material installed on an Uhlmann blister machine



Solutions





Out of spec: too thin|blow out

Receiver

Transmitter (MIR light source)

Thermoformed blister cavity or tray

Film thickness in microns

25

50

75

100

125

0

Threshold

Machine index



FormChecker – Material inspection system

Why? Applications and Benefits: • Thermoforming/Blow-Form processes of film & plastics

(e.g. blister or tray packaging processes) • Converting (e.g. laminating processes) • Film/layer thickness (e.g. transdermal patch process) Thickness and thickness distribution measurement

of material to ensure the barrier function of the package

Quality indicator for formed out / shaped out pocket/cavity

Integrity of forming material Blow-out detection

FORMCHECKER inspection system for formed and unformed plastic materials based on MIR (MidInfrared) technology



FormChecker – Application examples

FormChecker installed on an Uhlmann B1240 blister machine for formed PET material with blister cavities

FormChecker installed on an Uhlmann B1440 blister machine for formed PVC material



Solutions





Filled container sensor unit

In free-fall

Solid object or liquid substance sensor unit

Powder Stream sensor unit

In linear motion

Time

Sensor Signal units

Counter electrode

Area resp. peak signal of integral correlates to product mass in mg



VisioAMV – Inspection and Control system

High-speed measurement (Advanced Mass Verification) based on object’s mass for powders, solid objects and liquids and any type non-metallic items.

Measurement typically is correlated to product mass (from approx. 0.1mg to ∞) or other parameters which are application dependent.

Electro-capacitance technology based on product’s and environmental electrical relative permittivity




Why? Applications and Benefits: 1/2 • Application: Compacting process (e.g. tablets on a tablet press or compacted non-wovens)

Overall mass/density of product

• Application: Film/layer thickness determination (e.g. transdermal patch process) How much substance is applied onto carrier

• Application: Closed container measurements (e.g. liquid in glass container) How much is the fill level based on mass inside a carrier




Why? Applications and Benefits : 2/2 • Application: Shape-based measurement of objects (e.g. containers) The proper orientation/placement of the object

• Application: Filling/Dosing measurement of micro- & bulk-doses (e.g. powder or liquid in capsules,

cartridges, blisters, cavities/trays or other containers) How much mass was dosed/dispensed + process control of dosing/dispensing

• Application: Feeding process in packaging (e.g. tablets or ‘carrier’ products such as capsules into

blisters, objects into cavities/trays or other type containers) What is the product’s mass resp. presence of substance inside a ‘carrier’



VisioAMV – Application examples

VisioAMV application on a Harro Höfliger drum filler


Sensor signal units

Powder puck

Blister cavity Time

Area resp. peak signal of integral

correlates to product mass in mg




VisioAMV application on a Bausch & Ströbel auger filler


Mass in mg

Target weight reached: controlled by VisioAMV

Time

Cartridge Fill target




VisioAMV application on a vial transport system

Filled container sensor unit

Peak signal of integral correlates to mass of

substance in container

Sensor signal units

Time

Counter electrode



Sensor signal units

Solid object or liquid substance

sensor unit

Blister cavity

100%

75%

50%

25%

Empty

Peak signal correlates to powder mass in mg inside

capsule

Time

Sectional view of an Uhlmann SimTap feeding system: VisioAMV integrated into an Uhlmann SimTap feeding system to check capsules for their powder/pellet content

VisioAMV VisioAMV




Solutions





Time

Inductance intensity ≙ total blisters (in layers)

Receiver

Sender

Blister stack with leaflet in a closed carton

1

2

3

4

5

0



VisioCount – Inspection system Why? Applications and Benefits: • Inspection of metallic objects in container (e.g. blister

strips in a closed carton) • Metal detection during filling/dosing of micro- & bulk-

doses (e.g. powder or liquid in capsules, cartridges, blisters, cavities/trays or other type containers)

Completeness check of a closed container Small footprint which allows integration in existing

processes Filled/doses product is/are free of metallic

contaminants

High-speed inspection system for the detection of metallic objects



Solutions





Spec

trom

eter

Tran

smitt

er

(NIR

ligh

t sou

rce)

e.g. liquid filled vial Lense

Transmission Principle

Absorbance Specific areas of the spectral data ‚contain‘ product-relevant characteristics of interest

(e.g. active ingredient of product)

Wavelength



Absorbance

Wavelength

Specific areas of the spectral data ‚contain‘ product-relevant characteristics of interest (e.g. active ingredient of product) e.g. capsule

Lense

Tran

smitt

er

(NIR

ligh

t sou

rce)

Spectrometer

Reflection Principle



VisioNIR – ‘Forensic’ inspection system High-speed NearInfraRed (NIR) measurement based on transmission of light through objects or reflection of light from objects.

The received spectral data of the light contains the physical and chemical ‘fingerprint’ of the object.

Application dependent evaluation of this data allows quantifying or qualifying the object’s unique characteristics of interest.

Spectral analysis technology built in a flexible and modular design which can be adapted application-specific to fit different processes.



VisioNIR – ‘Forensic’ inspection system

Why? Applications and Benefits: 1/4 • Application: Verification of unlabeled bulk material (e.g. unlabeled vials)

Any mix-up possibility of unlabeled materials are safely ruled out

• Application: Content measurement (e.g. of an insulin suspension) Increased productivity by maximizing output to the acceptable threshold

• Application: Discrimination of look-alikes such as Actives vs. Placebos in Clinical Trial

Packaging -Recovery of already packaged products Production security increased Batch recovery maintaining all pharmaceutical safety standards




Why? Applications and Benefits: 2/4 • Application: Blend uniformity in continuous manufacturing and batch processes

Active product (e.g. API) and exipient product are effectively blended

• Application: Residual moisture detection, broken cakes and melt-backs in freeze-dried (lyophilized) product

Shelf life will be reached as expected Non-conforming products are effectively sorted out




Why? Applications and Benefits: 3/4 • Application: Content uniformity on tablet presses (with regards to correct compression

force, particle size, humidity, etc. of product) Proper drug delivery is ensured

• Application: Measurement of overall tablet product quality (Quality indicator) during

bulk inspection and sorting process Product issues are ruled out prior to bulk materials reaching the packaging floor




Why? Applications and Benefits: 4/4 • Application: Measurement of moisture content and API in granulation & drying processes

Active product (e.g. API) and exipient product are effectively processed (i.e. no over-drying)

• Application: Verification of membrane presence within a time-release tablet

Production security and patient safety increased



VisioNIR – Application examples Verification (‘ID-ing’) of un-labeled bulk right before customization

Manufacturers of liquid medication often produce multiple lots which will be customized at a later stage. I.e. the filled ampoules, vials etc. are stored as un-labeled bulk material until an order triggers a packaging lot. At this stage each product is labeled, i.e. customized. In order to avoid dangerous mix-up situations an inline installed NIR system identifies each product before it is labeled. The application is performed in real-time and to 100% vs. sample testing (InProcessControl/IPC), i.e. potential quarantine and lab testing times are obsolete.

VisioNIR application on a Bausch & Ströbel labeler



VisioNIR – Application examples Measurement of insulin content in a suspension

Insulin (suspension) is typically tested using HPLC. With the introduction of NIR technology right at after the suspension is filled, each cartridge is checked for its insulin concentration. This allows running production down to the low-concentration threshold and therefore saves product as well as pinpointing irregularities in the filling nozzles and hoses and rejecting these outliers. The application is performed in a non-destructive way in real-time and to 100% vs. destructive sample testing (HPLC). Also, the overall release time is significantly reduced.

VisioNIR application on a Bosch/Eisai particle inspection machine



VisioNIR – Application examples Discrimination of ‘look-alikes’ such as Active vs. Placebo

The proper placement of active and placebo products during a clinical study is an essential part in new drug studies. The developers of a drug have to examine in detail the effects on test persons of active versus placebo medication, which requires the products to look alike and cannot be distinguished by the human eye nor with traditional vision systems. VisioNIR can safely rule out mix-ups in packaging. In addition, lots already packaged which are ‘suspicious’ can be reliably re-inspected in the same way using VisioNIR technology.

VisioNIR application on an Uhlmann B1240 blister machine



VisioNIR – Application examples Measurement of blend uniformity in a continuous mixing process

Today, mixing processes are already performed in a continuous way. In case of mixing pharmaceuticals, the uniformity of the blend is essential and information regarding Active Pharmaceutical Ingredient (API) dosing content a critical process parameter. Using high-speed NIR technology allows to measure the blend uniformity as well as control its dosing unit to maintain the desired mix of API. The application is performed in a non-destructive way in real-time and to 100% vs. destructive sample testing (e.g. HPLC). Also, the overall release time is significantly reduced.

VisioNIR application on Loedige continuous mixer



VisioNIR – Application examples Measurement of residual moisture in freeze-dried / lyophilized products in vials

Manufacturers of lyophilized products often face challenges of residual moisture in the product (typically in the lyo cake) which has a significant impact on the drugs shelf life. Other challenges in the lyophilization process are so called broken cakes and melt-backs. An inline NIR system can determine if any of the mentioned deficiencies are present. The application is performed in a non-destructive way in real-time and to 100% vs. destructive sample testing (Karl-Fischer). Also, the overall release time is significantly reduced.

VisioNIR application on a Wilco inspection machine



VisioNIR – Application examples Measurement of overall tablet content uniformity

The compacting process of tablets performed on a tablet press is essential for the efficacy of a drug. The right compression force, the degree of humidity in the compound, particle size and other characteristics are critical parameters which are influenced or detectable in this processing step. An inline integrated NIR system checks for these physical-chemical characteristics (quality indicator) to rule out deficiencies. The application is performed in a non-destructive way in real-time and to 100% vs. destructive sample testing (e.g. HPLC). Also, the overall release time is significantly reduced.

VisioNIR application on Fette tablet compacting machine



VisioNIR – Application examples Measurement of overall tablet quality (Quality indicator) during bulk inspection and sorting process

Bulk material is often inspected by optical means for cosmetic defects right after they are produced. The additional use of NIR technology in this step also assures the manufacturer of the correct chemical composition of the product. In combination one can be sure that a pharmaceutical product not only looks good but also is good ‘inside’ from the content point of view. The application is typically performed in real-time and to 100% before the bulk material is put into storage drums for further packaging processes.

VisioNIR application on a Proditec 360° inspection machine



VisioNIR – Application examples Measurement of moisture content and API in granulation & drying processes

Demands for real-time analyzing of pharmaceutical manufacturing processes to ensure product quality and process stability are increasing. For example in fluid bed processing, information regarding moisture content in the material could only be determined indirectly by means of other physical parameters such as the exhaust air humidity. Important product characteristics such as moisture content and the homogeneity of the Active Pharmaceutical Ingredient (API) can be measured in real-time and directly using NIR technology.

VisioNIR application on a Glatt fluid bed granulator



VisioNIR – Application examples Continuous inspection of a granulation process for powder stream monitoring through a glass sight funnel The continuous inspection of wet and dry granulation and mixing processes requires a robust and multi-purpose measuring head to handle flow capacities from 1-15 kg per hour. The inner surface is designed to ensure that no product residue is collected on the sensor and the special setup of the optical pathway enables the measurement of small powder amounts. An automatically performed white balance can be operated via the software.

VisioNIR application on a Glatt granulator



VisioNIR – Application examples Verification of membrane presence within a time-release tablet

Manufacturers of time-release drugs depend on the presence of a membrane within the pharmaceutical product enclosing the API of the product. Only through a micro-drilled hole in the membrane can stomach liquids release the drug’s API and therefore release it over time for a long-lasting efficacy. The presence and integrity of this membrane can be checked using NIR technology. The application is performed in a non-destructive way in real-time and to 100% vs. destructive sample testing. Also, the overall release time is significantly reduced.

VisioNIR application on an Ackley tablet printer



Solutions





0...... ..50..........75..........100

Force sensor

Plate

Vacuum chamber

Formed blister or tray cavity

Support plate Support plate

Vacuum valve

Decay of pressure over time can be directly correlated to the size

of the pinhole in micron.

Over-pressure environment in cavity

Low-pressure environment

Force sensor / time measurement result



VisioLeak – Application examples

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VisioLeak installed in-line with an Uhlmann B1260 blister machine

VisioLeak connected at-line to an Uhlmann UPS 1070


VisioLeak – Leakage inspection system

Why? Applications and Benefits: • Leakage inspection in blister or tray packaging processes • Leakage inspection of pouches Barrier function of final package Tightness /strength of material/sealing – bond of final package



Thank you very much for your attention.

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