Bio-Technology R

1
Bio-Technology RDPerformance Enhancement
Innovative Product Development Through Pore
Structure

• Akshaya Jena and Krishna Gupta
• Porous Materials, Inc.
• Ithaca, NY, USA

2
Dependence of Performance on Pore Structure
Characteristics

• Many innovative products are currently being
  increasingly used in biotech industries
  including
• Health care
• Medical
• Pharmaceutical
• Examples of such products
• Substrates for tissue growth
• Drug delivery systems
• Implants
• Wound dressings
• Arterial grafts
• Filters for separation of bacteria from body
  fluids,
• Substrates for organ culture
• Pore structure of these products governs the flow
  and the kinetics of the bio-chemical processes
  which occur during applications

3
Dependence of Performance on Pore Structure
Characteristics

• Performance dependent on their pore structure
  characteristic
• Influence of application
• environment on pore structure
• needs to be determined
• Chemical environment
• Operating temperature
• Humidity
• Stresses generated during
• the operation

4
Techniques for Measurement of Pore Structure
Characteristic

• Many techniques are available for evaluation of
  pore structure characteristics relevant for
  bio-technical applications

5
Techniques for Measurement of Pore Structure
Characteristic

• Liquid Extrusion Porosimetry
• Measures
• Through pore volume
• Through pore diameters
• Pore distribution
• Hydrophobic through pores
• Hydrophilic through pores
• Structure over a range of
• Temperature
• Stress
• Chemical environment
• Controlled humidity

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Techniques for Measurement of Pore Structure
Characteristic

• Capillary Flow Porometry
• Measures
• Wide range of through pore throat diameters
• Pore distribution
• Gas permeability
• Structure over a range of
• Temperature
• Stress
• Chemical environment
• Controlled humidity
• Permeametry
• Measures
• Gas, vapor, and liquid transmission rates
• Many chemical species
• Over wide range of concentration, temperature,
  and stress on the sample

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Techniques for Measurement of Pore Structure
Characteristic

• Water Vapor and Gas Transmission Analysis
• Measures
• Water vapor transmission rate
• Uses many gradient
• Humidity
• Temperature
• Concentration
• Pressure
• Vacuapore
• Measures
• Through and blind hydrophobic pore volume
• Through and blind hydrophobic pore diameter
• Distribution of hydrophobic pores

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Techniques for Measurement of Pore Structure
Characteristic

• Mercury Intrusion Porosimetry
• Measures
• Through and blind pore volume and diameter
• BET Sorptometry
• Measures
• Surface area of through and blind pores
• Very small through and blind pore volume
• Pore diameter and distribution
• Chemisorptions of many chemicals over a wide
  range of temperatures and pressures
• Pycnometry
• Measures
• True and bulk density

9
How Can PMI Help?

• What is PMI?
• Porous Materials, Inc. designs, manufactures, and
  sells instruments for pore structure
  characterization
• Has vast experience in patenting of novel
  technology for pore structure characterization
  and developing custom instruments for a wide
  variety of applications

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How Can PMI Help?

• What is PMI?
• Has published many papers and presented many oral
  and poster papers in conferences on pore
  structure characterization of the products of
  biotech industries
• Has supplied instruments to many biotech related
  industries and research laboratories all over the
  globe

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Pore Structure Characterization Instruments by PMI

• PMI Liquid Extrusion Porosimeter

• PMI Advanced Capillary Flow Porometer

• Specially designed for biotech industry
• Wide range of through pores
• Wide range of sample sizes including miniature
  samples

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Pore Structure CharacterizationInstruments by PMI

• Water Vapor Gas Diffusion Analyzers
  Permeameters

• Unique products widely used in the biotech
  industry

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Pore Structure CharacterizationInstruments by PMI

• PMI Vacuapore

Suitable for analysis of hydrophobic and
hydrophilic pores

• PMI Mercury Intrusion
• Porosimeter

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Pore Structure Characterization Instruments by PMI

• BET Sorptometer

• Gas Pycnometer

• All instruments needed to investigate pore
  structure in the biotech industry are
  manufactured by PMI.

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All PMI Instruments Fully Automated

• Fully automated
• Test execution
• Data acquisition
• Data storage
• Data reduction
• Windows-based, menu driven, simple operation
• Objective, accurate reproducible results

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PMI In-House Contract Testing Laboratory

• Performs tests on biotech samples submitted from
  all over the globe
• Test time can be as short as two days

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Example of Application of PMI Instruments

• Pore Structure Characterization of Substrates for
  Tissue Growth and Culture

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Through Pore Volume

• Instruments used to measure through pore volume
• PMI Liquid Extrusion Porosimeter
• Only through pores relevant for biotechnology
  measured
• Large 500 ?m pores measureable
• Highly repeatable
• Click here for more information on this topic

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Through Pore Distribution

• Instruments used to measure through pore
  distribution
• Volume distribution of the through pores
• PMI Liquid Extrusion Porosimeter
• Volume distribution of through and blind pores
• PMI Mercury Intrusion Porosimeter

• Expected identical pore volume by both methods
  (No blind pore in nanofiber substrate)
• Expected high Porosity, 81.7
• Much higher resolution by liquid extrusion
  technique
• High pressures and toxic mercury completely
  avoided by extrusion technique

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Characteristics of Through Pore Throat Diameters

• Through pore throat diameters determine nutrient
  and drug permeation rate and govern separation of
  entities like bacteria from body fluids, drugs,
  drinking water, food and beverages.
• Instrument used to measure through pore throat
  diameters PMI Capillary Flow Porometer
• Measures
• The largest pore throat diameter
• Mean flow pore throat diameter
• Pore distribution
• Click here for more information on this topic

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Characteristics of Through Pore Throat Diameters

• Narrow distribution demonstrated (The largest
  throat diameter is 2.91 ?m and the mean is 1.65
  ?m )
• The flow based mean throat diameter (1.65 ?m) is
  close to the volume based median pore diameter
  (3.27 ?m)
• Results suggest inappreciable change in pore
  diameter along pore path
• Click here for more information on this topic

Distribution of through pore throat diameters in
a nanofiber coated substrate
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Liquid Permeability

• Permeability helps accessibility of fluids for
  tissue in-growth
• Instrument used for permeability PMI Liquid
  Permeameter

Excellent tissue in-growth in high permeable
reticulated foam substrate
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Mean Flow Pore Diameter
Correlation between percent tissue in-growth and
ratio of liquid permeability and mean flow pore
diameter for a laser consolidated metal implant

• Critical flow rates and pore diameters govern
  tissue in-growth
• Mean pore diameter measured by PMI Capillary
  Flow Porometer
• Click here for more information on this topic

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Special Needs

• You can visit our website to see the wide
  spectrum of pore structure capability that our
  instruments offer
• If you have a special need that is not part of
  PMIs standard test list, the engineers at PMI
  will be happy to talk to you about your testing
  requirements and come up with a suitable solution