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BlendAlyser - Turnkey system for online monitoring of blending processes. Table of content. Introduction Definition „Blending process“ BlendAlyser - Process monitoring BlendAlyser - Design and technical specification . 1. Analytical Measuring Optics. application specific measurement systems.

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Presentation Transcript
slide2

Table of content

  • Introduction
  • Definition „Blending process“
  • BlendAlyser - Process monitoring
  • BlendAlyser - Design and technical specification
slide3

1. Analytical Measuring Optics

  • application specific measurement systems
  • optical sensors
  • spectroscopic modules and components
  • partner in optical measurements for chemical or biological parameters
  • technological know how, high tech products and additional services
slide4

Your qualified partner in laboratory and process technologies

  • Development and fabrication of

optical measuring systems

  • Services, such as
    • test measurements
    • instrument demonstrations
    • trainings
    • individual advisory services

Do not hesitate to ask us if any questions shall come up!

slide5

Components for optical spectroscopy:

  • UV/VIS and NIR spectrometers
  • Light sources
  • Probes and sample holders
  • User and analyzer software
  • Fiber optic probes and fiber

optics

If you want to set up your own measurement system just ask us and benefit from our knowledge!

slide6

Optical sensors for determining chemical and physical parameters:

  • Fiber optical Oxygen sensors for measurements in liquids and gases
  • CO2- and CH4-Sensors for monitoring

fermentation processes

  • Temperature measurement in

electromagnetic fields

slide7

Compact analyzer for online monitoring of blending processes

BlendAlyser - latest development for contact-free online monitoring of powder blending processes.

This instrument is well tailored for the needs of pharmaceutical industries

and research establishments.

slide8

2. Definition: Blending process

Definition: Blending (process engineering):

Main aim of the blending process is the production of a blend whose sample reflects exactly, or at least by pre-defined accuracy, the ratio of the added base materials.

Pharmaceutical industry – solid blend of agent (API) and several additives (up to 10)

slide9

Main goal of blending processes in pharmaceutical industries:

Tablet production which requires identical ingredients and homogenous distribution of the active pharmaceutical ingredient (API) as well as additives.

slide10

Principle of tablet production

Active substance

synthesis

Blending and Granulation

Compression

Coating

Package

slide11

Schematic blender design

Active Pharmaceutical Ingredient

(API)

Excipients

Measurement window to which the BlendAlyser is mounted

slide12

Problems which may arise during blending processes

  • inhomogeneity in material blends
  • deblending due to exceeded blending times
  • increased time and cost consumption due to exceeded blending times
  • general failures

Solutions:

Sampling at the blender  offline lab analysis of material mixture (e.g. by HPLC)

Online process monitoring enabling the moving blender is no longer necessary, online blend analysis, immediate results

slide13

3. Process monitoring with the BlendAlyser

  • Features
  • solid end point detection of blending processes
  • avoids deblending
  • online analysis of blending and production processes
  • quantitative analysis of different ingredients
slide14

BlendAlyser

Connection via 4“ standard flange using a flange fastener

Blender system

The measuring instrument is directly mounted to the blender. Measurement is performed online.

slide15

Advantages:

  • optimized production processes
  • improved process knowledge
  • expensive and time consuming laboratory analysis are no longer
  • necessary
  • improved quality assurance
  • time and cost savings
  • real-time analysis
slide18

Absorbance in AU

Online monitoring of end point detections via NIR spectra

Wavelength in nm

slide19

Absorbance in AU

Online monitoring of end point detections via NIR spectra

Wavelength in nm

slide20

Absorbance in AU

Online monitoring of end point detections via NIR spectra

Wavelength in nm

slide21

Blend process‘ end point – homogeneous blend

Absorbance in AU

Beginning of the blend process

Online monitoring of end point detections via NIR spectra

Wavelength in nm

slide22

Different ways for determining homogeneity

  • monitoring of standard deviations within a certain spectral
  • range (e.g. Moving Block StdDev I)
  • absorbance monitoring at significant peaks
  • quantitative analysis (e.g. concentration determination
  • using PLSR)
  • PCA (Principal Component Analysis)
slide23

Homogeneous blend

Previous blending time

End point detection via Moving Block Standard Deviation I of absorbance at selected wavelength ranges

slide24

End point detection by absorbance determination at signification peaks

Homogeneous blend

Addition of magnesium stearate in order to improve miscibility

slide25

End point detection by measuring API’s concentration variations – determination of chemometric calibration

Homogeneous blend

slide26

End point detection via PCA (Principal Component Analysis)

Homogeneous blend

till addition of magnesium stearate

after addition of magnesium stearate

slide27

4. BlendAlyser Setup

Compact IP65 stainless steel housing with

Weight: 6.5 kg / 14.3 lb

Dimensions: 230 x 210 x 150 mm / 9 x 8.5 x 6 inch

slide28

Detector1

Etalon

Detector2

Tunable

Source

Sample

Interface

Beamsplitter

Beamsplitter

Detector3

Setup of Tunable Laser Systems

WARM® design - Wavelength and Amplitude Reference Module

slide29

Integrated angle sensor for measurement trigger

  • BlendAlyser contains a MEMS based 3 axis
  • angle sensor system.
  • (360°, normalized to instrument axis)
  • optimum trigger angle e.g. at 180° +/- 35°
  • user configurable by software
  • one single measurement
  • at every blender revolution
  • alternatively, triggering is possible
  • by digital I/O (5-24VDC)
slide32

Product features

Flat anodized aluminium heat sink for GmP

compliance, IP65 stainless steel housing

  • 2 orthogonal antennas
  • (antenna diversity) for increased
  • connections stability
  • 802.11 b/g wireless ethernet

Status LED’s

slide33

Status LED

Status LED with control function:

  • System status
  • Battery status
  • Trigger status
  • Network status
slide34

Safe and easy battery replacement

Battery slot for easy replacement

  • hot swappable battery change due to back-up storage battery
  • battery powered up to 3hrs working time
slide35

Power Plug

Power plug

(internal battery charger)

or

Power supply by slit rings

slide36

Easy adjustment to different blending systems

Modular process interface, can be customised to fulfil specific implementation needs standard: 4“ hygienic clamp, 18mm working distance

Installation on lab and process blenders!

slide37

Hidden service plugs

Service plug for direct connection to

- monitor

- keyboard / mouse

- USB

slide38

Fewest service needs

Fewest service needs due to

  • no moving parts
  • no serviceable parts
  • expected TL-source life time ~20 years
slide39

Highlights of the BlendAlyser

  • High resolution spectrometer based on MEMS technology
  • Programmable 3D orientation sensor as trigger
  • Battery powered up to 3hrs working time
  • Battery hot swappable
  • Compact all-in-one system
  • Internal embedded PC for data safety
  • WLAN communication (IEEE 802.11 b/g)
  • Smooth surfaces, cGMP compliant
  • Validated software (IQ/OQ/PQ-documentation)
slide40

Data flow diagram

BlendAlyser

NovaPAC

NovaMath

Spectra

Method

Results

files

Events

/

Log

data server

Chemometrician desk

(

LAN

)

Methods

Models

Spectra

Results

Events

/

Log

NovaMath

Workstation

Server