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Open discussion on rapid
microbiological methods
Tim Sandle
http://www.pharmamicroresources.com/
Things we can discuss
• What is driving rapid methods?
• What care the technological and business
advantages?
• What are the main types of rapid methods?
• What makes for a ‘good’ rapid method?
• What is stopping implementation?
• How can a business case be made?
• What are the main types? What do are you
currently looking at? What would you like to
look at?
Drivers
• FDA Process Analytical Technology.
• Quality by Design (QbD).
• Business needs e.g. Batch progression
• Scientific advancement.
Advantages
• Faster (reduced time-to-result);
• More accurate (increased sensitivity,
accuracy, precision and reproducibility);
• Require fewer microbial cells to produce a
result;
• Enhanced detection of stressed organisms;
• Semi-automated or automated;
• Improved throughput;
• Less subjectivity.
Advantages
• Significant reduction of testing time to release
products more rapidly;
• Lower inventories (raw material, in-process
material and finished product);
• Prevention of back orders;
• Reduction of repeat testing, deviations, OOS
investigations and product rejection.
Types
• Measurements can be qualitative, that is,
determining if contaminants are either
present or absent in a test sample.
• Measurements can be quantitative, that is to
precisely determine the number of organisms
present in a test sample.
• Technologies designed to specifically identify
the microorganism associated with
contamination.
10 important attributes
1. Accuracy for the intended purpose,
2. Speed in productivity,
3. Cost,
4. Acceptability by the scientific community
5. Acceptance by regulatory agencies,
6. Simplicity of operation, including training
requirements, and reagents,
7. Reputation of the vendor,
8. Technical services provided by the vendor,
9. Utility requirements,
10. Space requirements.
Why not implement?
• Scientific or technological hurdles,
• Regulatory concerns,
• Economics,
• Validation costs and time
The business case
• initial feasibility assessment;
• costs for the equipment itself;
• testing costs;
• development of user requirements;
• testing protocols and SOPs;
• training;
• execution of the validation program;
• documentation;
• regulatory submission;
• technology transfer;
• site implementation.
Group of technologies
• Is anyone using these?
• Does anyone plan to use these?
• What are the advantages?
• What are the disadvantages?
• What are the obstacles to implementation?
• What is needed for validation?
• How long will the process take?
Growth-based technologies
• Growth-based
technologies rely on the
measurement of
biochemical or
physiological parameters
that reflect the growth of
microorganisms.
• These types of systems
require the organisms in a
sample to proliferate,
either on a solid or liquid
medium, in order to be
detected and/or
quantified.
• Examples
• ID systems e.g. VITEK;
OmniLog
• ATP-bioluminescence
systems:
– Millipore’s Milliflex Rapid
System,
– Celsis Advance
Luminometer,
– Pall’s (East Hills, N.Y.)
PallChek Microbiology
System.
• Rapid Micro Biosys
Growth Direct - relies on
the growth of
microorganisms on agar.
Viability-based technologies
• Viability-based
technologies use
viability stains
and/or cellular
markers to detect
and quantify
microorganisms
without the need for
cellular growth.
• Examples
• Chemunex ScanRDI
solid-phase
cytometry platform
• Flow-cytometry
systems such as the
Chemunex D-Count
and BactiFlow
Artefact-based technologies
• Artefact-based
technologies rely
on the analysis of
cellular components
or the use of probes
that are specific for
microbial target sites
of interest.
• Examples
• MIDI Sherlock
Microbial
Identification
System;
• MALDI time-of-flight
mass spectrometry;
• Endosafe PTS
system
Nucleic acid-based technologies
• Nucleic acid-based
technologies rely
on PCR DNA
amplification, 16S
rRNA typing, gene
sequencing and
other novel
applications.
• Examples
• DuPont Qualicon
RiboPrinter;
• Applied Biosystems
MicroSeq
Real-time particle counting
• Spectrophotmetic methods.
• Optical spectroscopy measures the
interactions between light and the material
being studied. Light scattering is a
phenomenon in which the propagation of light
is disturbed by its interaction with particles.
Pharmaceutical Microbiology
http://www.pharmamicroresources.com/

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Open discussion on rapid microbiological methods.pptx

  • 1. Open discussion on rapid microbiological methods Tim Sandle http://www.pharmamicroresources.com/
  • 2. Things we can discuss • What is driving rapid methods? • What care the technological and business advantages? • What are the main types of rapid methods? • What makes for a ‘good’ rapid method? • What is stopping implementation? • How can a business case be made? • What are the main types? What do are you currently looking at? What would you like to look at?
  • 3. Drivers • FDA Process Analytical Technology. • Quality by Design (QbD). • Business needs e.g. Batch progression • Scientific advancement.
  • 4. Advantages • Faster (reduced time-to-result); • More accurate (increased sensitivity, accuracy, precision and reproducibility); • Require fewer microbial cells to produce a result; • Enhanced detection of stressed organisms; • Semi-automated or automated; • Improved throughput; • Less subjectivity.
  • 5. Advantages • Significant reduction of testing time to release products more rapidly; • Lower inventories (raw material, in-process material and finished product); • Prevention of back orders; • Reduction of repeat testing, deviations, OOS investigations and product rejection.
  • 6. Types • Measurements can be qualitative, that is, determining if contaminants are either present or absent in a test sample. • Measurements can be quantitative, that is to precisely determine the number of organisms present in a test sample. • Technologies designed to specifically identify the microorganism associated with contamination.
  • 7. 10 important attributes 1. Accuracy for the intended purpose, 2. Speed in productivity, 3. Cost, 4. Acceptability by the scientific community 5. Acceptance by regulatory agencies, 6. Simplicity of operation, including training requirements, and reagents, 7. Reputation of the vendor, 8. Technical services provided by the vendor, 9. Utility requirements, 10. Space requirements.
  • 8. Why not implement? • Scientific or technological hurdles, • Regulatory concerns, • Economics, • Validation costs and time
  • 9. The business case • initial feasibility assessment; • costs for the equipment itself; • testing costs; • development of user requirements; • testing protocols and SOPs; • training; • execution of the validation program; • documentation; • regulatory submission; • technology transfer; • site implementation.
  • 10. Group of technologies • Is anyone using these? • Does anyone plan to use these? • What are the advantages? • What are the disadvantages? • What are the obstacles to implementation? • What is needed for validation? • How long will the process take?
  • 11. Growth-based technologies • Growth-based technologies rely on the measurement of biochemical or physiological parameters that reflect the growth of microorganisms. • These types of systems require the organisms in a sample to proliferate, either on a solid or liquid medium, in order to be detected and/or quantified. • Examples • ID systems e.g. VITEK; OmniLog • ATP-bioluminescence systems: – Millipore’s Milliflex Rapid System, – Celsis Advance Luminometer, – Pall’s (East Hills, N.Y.) PallChek Microbiology System. • Rapid Micro Biosys Growth Direct - relies on the growth of microorganisms on agar.
  • 12. Viability-based technologies • Viability-based technologies use viability stains and/or cellular markers to detect and quantify microorganisms without the need for cellular growth. • Examples • Chemunex ScanRDI solid-phase cytometry platform • Flow-cytometry systems such as the Chemunex D-Count and BactiFlow
  • 13. Artefact-based technologies • Artefact-based technologies rely on the analysis of cellular components or the use of probes that are specific for microbial target sites of interest. • Examples • MIDI Sherlock Microbial Identification System; • MALDI time-of-flight mass spectrometry; • Endosafe PTS system
  • 14. Nucleic acid-based technologies • Nucleic acid-based technologies rely on PCR DNA amplification, 16S rRNA typing, gene sequencing and other novel applications. • Examples • DuPont Qualicon RiboPrinter; • Applied Biosystems MicroSeq
  • 15. Real-time particle counting • Spectrophotmetic methods. • Optical spectroscopy measures the interactions between light and the material being studied. Light scattering is a phenomenon in which the propagation of light is disturbed by its interaction with particles.