Liquid Pharmaceuticals Scale up

מרצה: Mr. Igor Gorsky

תאריך: 25, 26 ספטמבר 2016
מיקום הקורס: כפר המכביה, רמת גן
מידע כללי
משך הפעילות: 2 ימי לימודים מלאים
שעות: 9:00 - 17:00
עלות: 4,300 ש"ח + מע"מ
נקודות זכות: 0
מק''ט: 16952
שפת הקורס: אנגלית
על הקורס

One of the most important processes involved in the scale-up of liquid pharmaceutical preparations is mixing. For liquids, mixing can be defined as a transport process that occurs simultaneously in three different scales, during which one substance (solute) achieves a uniform concentration in another substance (solvent).

On a large, visible scale, mixing occurs by bulk diffusion, in which the elements are blended by the pumping action of the mixer’s impeller. On the microscopic scale, elements that are in proximity are blended by eddy currents, and they create a drag, where local velocity and shear-stress differences act on the fluid. On the smallest scale, final blending occurs via molecular diffusion, whose rate is unaffected by the mechanical mixing action. Therefore, large-scale mixing depends primarily on flow within the vessel, whereas small-scale mixing is dependent mostly on shear. The approach discussed in this class focuses on large-scale mixing using three viable approaches, specifically concentrating on the scale-of-agitation method.

This course is designed to explore mechanics of mixing technologies and impact of scale-up on processes. Considerable attention is given to the scale of agitation method and its implementation for true solutions as well as suspensions. Attendees will perform hands on liquid scale-up problem solving examples. Risk based lifecycle approach validation of scaled-up processes will also be discussed along with rapid detection technologies and process analytical technologies.

קהל היעד
  • Process Development
  • Quality Assurance
  • Quality Control
  • Validation
  • Production/Operations
  • Engineering
התועלת שתופק
  • This course is designed for engineering and non-engineering pharmaceutical and biopharmaceutical professionals to provide learning fundamentals of mixing processes, dimensionless numbers that describe them, mixing technology elements so that they are well equipped to tackle scale-up challenges.
  • This course will also help pharmaceutical and biopharmaceutical firms’ personnel understand Scale of Agitation approach to scale-up of liquids which is a viable and an universal avenue to scale-up solutions.
  • In addition, instrumentation, detection and PAT solutions to sampling and testing will be discussed to help in learning best approaches to risk based lifecycle validation solutions of liquid mixing processes’ scale-up.
  • A special benefit to attendees would be hands on example of scale-up calculations.  

Key Learning Objectives

  • Understanding of mixing process
  • Mixing process mechanisms
  • Dimensionless numbers
  • Liquids/Solids, Liquids/Liquids and Liquids/Gas Mixing
  • Heat Transfer in Mixing Process
  • Scale of Agitation and its implementation
  • Instrumentation, Rapid Detection and PAT Technologies
  • Risk Based Life Cycle Approach to Scaled Up Liquid Processes
השאר פרטים למידע נוסף
  • שם מלא
  • דוא''ל
  • טלפון
  • הערות
  • שלח
תכני הקורס

Day 1

  • Mixing Overview
    • Process
    • Power
    • Fluid Mechanics
    • Sampling
    • Mixing Mechanisms
    • Impellers
    • Geometry
  • Mixing Mechanisms
    • Horsepower
    • Pumping Capacity
    • Shear Rate
    • Tank Geometry
  • Dimensionless Numbers
    • Mechanical unit operations
      • Reynolds
      • Froude
      • Galilei
      • Archimedes
      • Euler
      • Newton
      • Weber
      • Ohnesorg
      • Mach
      • Knudsen
    • Thermal unit operations (heat transfer)
      • Nusselt
      • Prandtl
      • Grashof
      • Fourier
      • Peclet
      • Rayleigh
      • Stanton
    • Thermal unit operations (mass transfer)
      • Sherwood
      • Schmidt
      • Bodenstein
      • Lewis
      • Stanton
    • Chemical reaction engineering
      • Arrhenius
      • Hatta
      • Damkὄhler
  • Liquids/Solids Mixing
    • Velocity
    • Applications
    • Solids Incorporation
    • Process Definition
    • Power vs. Concentration
    • Power vs Settling Velocity
    • Viscosity
    • Impeller Location
    • Settled Solids
  • Liquid/Liquid Mixing
    • Different Liquids
    • Viscosity Effects
    • Specific Gravities Effects
    • High Viscosity Mixing
  • Liquid/Gas Mixing
    • Flow
    • Effect on Power
    • Commercial Scale Equipment
    • Methods of Mixing
  • Heat Transfer
  • Continuous Processes
  • Static Mixing

Day 2

  • Mechanical Design
    • Mixer Components
    • Mountings
    • Critical Speed
    • Fluid Forces
  • Sampling Techniques
  • Instrumentation
  • Scale of Agitation
    • Theory
    • Practical Example (Solving problem by attendees)
    • Latest revisions of Scale of Agitation
    • Scale of Agitation for Suspensions
  • Process Analytical Technology Implementation
  • Rapid Methods of Detection Discussion
  • Liquid Scale-Up and Risk Based Lifecycle Approach to Validation
אודות המרצה

Mr. Igor Gorsky

Mr. Igor Gorsky has over 30 years of experience leading validation, technology transfer, quality assurance and manufacturing functions in a wide range of pharmaceutical and biotechnology generic and brand firms. Prior to ConcordiaValsource, .
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