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PAT-enabling Hard- and Software

PAT-enabling Hard- and Software. Andrey Bogomolov J&M GmbH, Germany. Outline. Good news in 2007 one more person started to earn his leaving from doing chemometrics  J&M: the company Process monitoring J&M special equipment for PAT two industrial cases PAT philosophy

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PAT-enabling Hard- and Software

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  1. PAT-enabling Hard- and Software Andrey Bogomolov J&M GmbH, Germany

  2. Outline • Good news • in 2007 one more person started to earn his leaving from doing chemometrics  • J&M: the company • Process monitoring • J&M special equipment for PAT • two industrial cases • PAT philosophy • PAT chemometrics software concept • components making up a PAT solution

  3. J&M: Introduction • About J&M GmbH • since 1987 • spectroscopic equipment and components • specifically, UV-Vis/NIR, DAD, fiber optics, microspectroscopy • positioned as “fast and precise” • recent years trend: spectroscopic equipment for PAT • What kind of company? • strongly PAT-oriented • pro-chemometrics • active, growing • innovative • open-minded and collaboration-friendly

  4. J&M Products TIDAS II NIR (1100 – 2100 nm) Integrated in-situ Dissolution Test System 8-channel parallel Chromatography System Laboratory NOVA fully-integrated Process Analyser TIDAS fully-integrated spectrometer for pharmaceutical applications Industry

  5. PAT and beyond… • Process Analytical Technology (PAT) • is an initiative of FDA to create a regulatory framework for innovative pharmaceutical development and quality assurance • innovative methods [of data analysis=chemometrics] are allowed not only for research, but to provide the legal evidence (e.g. of product quality) for FDA • the impact goes beyond the regulated environment, since any production is more or less bound with quality requirements • The basic idea behind PAT is on-line process monitoring • product quality assurance • process control • process understanding • process optimisation • PAT and Chemometrics • chemometrics and spectroscopy are important components of PAT • multivarite statistical process control (MSPC) replaces classical [univariate] statistics in the industry

  6. quality& safety price producer profit, image process well-doing regulative organisation quality& safety consumer PAT players and driving forces

  7. Joint patent with GEA Pharma Systems Features and applications: for on-line measurement of diffuse reflectance NIR-spectra e.g. granulation, drying, blending, coating processes through 7 sapphire windows self-cleaning technology multiple applications moisture content, composition, homogeneity particle size monitiring process end-point detection etc. Advantages (compared to surface-mounted probes): reduced window fouling (cleaning) enhanced contributing sample weight better sampling: 3D-effect => better performance LightHouse ProbeTM (LHP)

  8. Case 1. Moisture monitoring • Granulation and drying • granulation is routinely carried out in the pharmaceutical production • fluid-bed granulator • drying is the last step • proceeds to a sertain residual moisture content (e.g. 2%) • Moisture monitoring • process end-point detection • Loss on Drying (LOD) the direct off-(at-) line technique • PAT Classics • NIR monitoring of H2O is well-established in-line technique

  9. r = 0.996 RMSECV = 0.17 a = 1 (!) heating was interrupted Case 1. Moisture monitoring (2) r = 0.993 RMSECV = 0.58 a = 2

  10. Case 2. Pellet Coating • Polymer coating of pellets for capsule filling • PrecesionCoaterTM • patented in 1998 • well-controlled particle flow due to the Swirl Accelerator • Process conditions • constant heating; product temperature is controlled • coating is followed by drying stage • Materials • pellet size up to 1100 µm • layer thickness up to 30-40 µm • Critical parameters • layer thickness • moisture content • Is it possible to predict the dissolution profile?!

  11. Case 2. Pellet Coating (2) moisture SNV-corrected spectra RMSEP = 0.12 a = 2 particle size RMSECV = 4.05 a = 3 predicted deviation calibration sample

  12. Probe window Wash tubes Movable Tip Mirror Additional wash tube ProDicht Project • On-going J&M project funded till 2010 • Reutlingen University (Prof. R. Kessler) • University of Applied Sciences, Offenburg (Prof. B. Spangenberg) • Light-Technical Institute, Karlsruhe • Laser technique by Optimags • Spectroscopic probe for liquids • transmission and reflection modes • tunable pathlength • supports UV-Vis, NIR, IR, Raman, Imaging, … • ability to combine multiple techniques • Analysis in condense/ dispersive media • milk, creams, grease • fat content

  13. Technically, PAT is… • PAT = Hardware + Software • PAT hardware • sensors • analytical [spectroscopic] instrumentation • computers • PAT software • instrument control software (data acquisition) • data processing and modelling (chemometric packages) • operating software (process visualisation, alarms, end-point detection) • information/knowledge management software (LIMS) • PAT software !? • connect all hardware and aquire the data • synchronise the data acquisition • build and connect models • predict, observe and operate process • document the process

  14. . .. … .. … . manage IMS analyse x=! Expert process acquire PAT Instrumental Data handling software • Levels of data handling • data acquisition • instrumentcontrol, visualisation • FFT, averaging • data [pre-]processing • baseline correction, smoothing, derivation, subtraction, normalisation, peak picking, integration, transforms etc. • [advanced] data analysis • modelling • decision making (chemometrics) • information management • LIMS, ERP, …

  15. Towards the PAT Software • Concept elements • process as the main object • PAT solution as an output • “universal process modelling language”? • modular [open] toolkit • PAT platform • expert (model building) and operating (routine application) level should be clearly separated • new principles of data handling • delivering the document on-line • “web-compatible” • remote information sources • web-based solutions • Software becomes a dominating part of the data analytical system

  16. service hardware science software PAT Solution • PAT company • software development • linked to hardware vendors • scientific expetise • independent Technical companies Consulting companies Software companies Academia

  17. Welcome to Collaboration • Scientific expertise • experimental design • sampling • image analysis • new algorithms • uncertainty estimation • Practical applications • industrial process control • environmental monitoring • quality control • … • Joint development • PAT hardware • PAT software • integrated systems

  18. The end Thank you for attention!

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