general overview visiotec solutions (v0.8.8.1)

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Innovative technologies smarter processes. ?

Welcome to

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Innovative technologies for smarter processes.

Welcome to

• Where we are coming from • Our solutions portolio

visiotec solutions for your processes...

© visiotec GmbH 3

Who we are visiotec GmbH is a subsidiary company of the Uhlmann Group and in the group the Center of Excellence for Process Optimization. Originally founded in 2000, the company was providing automation solutions solely for the pharmaceutical industry – with dedicated focus on one thing, and one thing only: What can we do to help our customer improving processes regarding PRODUCTIVITY & SAFETY and at the same time improving QUALITY? Does not seem that difficult, but it is indeed not that easy. Sounds familiar? In 2013, the company has re-organized by expanding its industry range in addition to the well-established Pharma business into other industries - and our focus stays solid:

PRODUCTIVITY & SAFETY + QUALITY. Or with other words: visiotec provides its customers globally with solutions through Innovative technologies for smarter processes.

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Our company

Part of the Uhlmann Group

Smart Processes 24


© visiotec GmbH 25

All around our customer: our team at work for you

Provide the Solution to You

Listen to You & Understand

Challenge

Expert Knowledge

Innovation & Technology


© visiotec GmbH 27

Formed aluminum blister cavity or tray

VisioScan – How does it work?

Receiver

Pinhole size in microns

Machine index

50 40

30 20

10

Threshold

Out of spec: 2 pinholes

Transmitter (IR light source)


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VisioScan – Inspection system

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

Applications: • Pinhole inspection for aluminum forming and lidding materials (e.g. blister or tray packaging processes)

Other applications: • Pinhole inspection of pouch materials • Pinhole inspection of tubular material (e.g. pipes) ...

Why? Benefits: • Barrier function of package • Tightness of material • Integrity of material ...


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VisioScan –Installation references

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


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Formed plastic blister cavity or tray

FormChecker – How does it work?

Receiver

Film thickness in microns

Machine index

125 100

75 50

25

Threshold

Out of spec: too thin | blow out

Transmitter (MIR light source)


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FormChecker – Inspection system

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

Applications: • Thermoforming/Blow-Form processes of film & plastics (e.g. blister or tray packaging processes) Other applications: • Converting (e.g. laminating processes) • Film/layer thickness determination (e.g. transdermal patch process) ...

Why? Benefits: • 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 • Level of application of layers and substances ...


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FormChecker – Installation references

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

FormChecker installed on a UPS 4 blister machine For formed PVC material


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Powder Stream

sensor unit

Solid object or liquid substance

sensor unit

Filled containers sensor unit

Sensor signal units

Time

in linear motion

In free-fall

Area resp. peak signal of integral

correlates to product mass in mg

VisioAMV – How does it work?


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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


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VisioAMV – Inspection and Control system Why? Applications and Benefits:

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 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’ ...


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VisioAMV – Installation references & application principle

Powder Stream

sensor unit

Sensor signal units

Time

Area resp. peak signal of integral

correlates to product mass in mg

Powder puck

Blister cavity

VisioAMV application on a Harro Höfliger drum filler


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Powder Stream

sensor unit

Mass In mg

Time

Target weight reached: controlled by VisioAMV

150

100

50

Filling process is controlled by VisioAMV

VisioAMV application on a Bausch & Ströbel auger filler Cartridge

200


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Filled containers sensor unit

Time

Peak signal of integral correlates to mass of

substance in container

Sensor signal units


VisioAMV application on a vial transport system


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Time

Sensor signal units VisioAMV integrated

in SimTap

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


Solid object or liquid substance

sensor unit

Blister cavity

Capsule

100%

75%

50%

25%

Empty

Area signal correlates to

powder fill level inside capsule


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Blister stack with leaflet in a

closed carton

VisioCount & C-Scan – How does it work?

Inductive sensor probe

Time

Inductive sensor probe

3

2

4

1

Inductance intensity ≙ total blisters (in layers)


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VisioCount & C-Scan – Inspection system

Applications: • Inspection of metallic objects in container (e.g. blister strips in a closed carton) and with C-Scan for leaflet detection

• Metal detection during filling/dosing of micro- & bulk-doses (e.g. powder or liquid in capsules, cartridges, blisters, cavities/trays or other type containers) ...

Why? Benefits: • Completeness of a closed container • Replace checkweigher entirely • Filled/doses product is/are free of metallic contaminants

...

High-speed inspection system for the detection of metallic objects


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Blister stack with leaflet in a

closed carton

VisioCount & C-Scan – How does it work?

Inductive sensor probe (spool)

Inductive sensor probe (spool)

IR intensity ≙ leaflet

(in %)

Time

Inductance intensity ≙ total blisters

(in layers)

2

1

3

4

(*) here: 50% = 1 folded leaflet is present

75

100

25

50*


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VisioNIR – How does it work?

Transmission Principle

Spec

trom

eter

Tran

smitt

er

(NIR

ligh

t sou

rce)

Absorbance

Wavelength

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

Liquid filled vial Lense


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VisioNIR – How does it work?

Reflection Principle

Spectrometer

Tran

smitt

er

(NIR

ligh

t sou

rce)

Absorbance

Wavelength

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

Capsule

Lense


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VisioNIR – 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.


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VisioNIR Why? Benefits / Applications:

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 Application: Blend uniformity in continuous manufacturing and batch processes Active product (e.g. API) and exipient product are effectively blended (i.e. no over-mixing) Application: Residual moisture detection, broken cakes and melt-backs in freeze dried (lyophilized) product Shelf life will be reached as expected


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VisioNIR Why? Benefits / Applications – cont.:

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 Any product issues are ruled out prior to bulk materials reaching the packaging floor 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

...


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VisioNIR – Installation references & application principle

VisioNIR application on a Bausch&Ströbel labeler

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.


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VisioNIR – Installation references & application principle 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 save 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 an Eisai particel inspection machine


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VisioNIR – Installation references & application principle Discrimination of look-alikes such as Actives vs. Placebos

in Clinical Trial Packaging -------------------------------------------------------------------------------- Recovery of already packaged products The proper placement / packaging of active and placebo products during a clinical study is an essential part in the overall approval process of a new drug or medication. The developers of a drug have to examine in detail the effects on test persons of actives versus placebo medication, which requires the products to look alike and cannot be distin-guished by the human eye or with traditional vision systems. VisioNIR can safely rule out mix-ups in packaging of those blind study products. Lots already packaged which are ‘suspicious’ can be reliably re-inspected in the same way using VisioNIR technology.

VisioNIR application on an Uhlmann blister packaging line


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VisioNIR – Installation references & application principle 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


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VisioNIR – Installation references & application principle 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 WILCO inspection machine


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VisioNIR – Installation references & application principle 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


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VisioNIR – Installation references & application principle Measurement of overall tablet product 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 an Proditec 360° inspection machine


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VisioNIR – Installation references & application principle 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 an Glatt fluid bed granulator


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VisioNIR – Installation references & application principle 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


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VisioLeak

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


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VisioLeak – Leakage inspection system

Applications: • Leakage inspection in blister or tray packaging processes

Other applications: • Leakage inspection of pouches ...

Why? Benefits: • Barrier function of final package • Tightness /strength of material/sealing – bond of final package ...

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Innovative technologies smarter processes. ?

Welcome to

Thank you very much for your attention.

general overview visiotec solutions (v0.8.8.1)

Technology

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formed pet material

blister cavitiesformchecker