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Relequa® Analytical Systems Ltd
   Solving moisture problems instantly – saving costs for the pharma industry




RELEQUA MOISTURE PROFILING SYSTEM
Equilibrium Relative Humidity (ERH)
The Relequa instrument exploits ERH technology:




   “The ERH of a material is the %Relative Humidity of
    the air surrounding it at the equilibrium point of
            moisture absorption/desorption”

 Relequa Analytical Systems   (© 2008 – 2012)
Equilibrium Relative Humidity


ERH is then:
A dynamic state for a material in equilibrium when its rate
 of moisture uptake is equal to the rate of free moisture
     being released from the surface of the material




 Relequa Analytical Systems   (© 2008 – 2012)
How the Relequa System Works

 Moisture interaction / migration in a pharma product
  environment is driven by the ERH of the product
  material(s)
 As a result, changes in this environmental system (eg.
  RH, temperature) can cause moisture interactions.
 These interactions can impact on chemical and physical
  properties of the material.
 The degree of change is determined by the Relequa
  system’s moisture profiling dynamics


 Relequa Analytical Systems   (© 2008 – 2012)
How the Relequa System Works

 Relequa’s analysis method works by detecting these
  changes in immediate environmental conditions
 The output is the Moisture Profile:




 Relequa Analytical Systems   (© 2008 – 2012)
The Principles of ERH

     The two principles of ERH are relevant to the
  investigational capabilities of the Relequa Moisture
                    Profiling system




Relequa Analytical Systems   (© 2008 – 2012)
The First Principle of ERH
 A material placed in an environment with %Relative
  Humidity above its ERH will always take in moisture
  from the environment with a typical profile type:
                                Moisture Uptake Profile
                      80



                      75



                      70
                %RH




                                                          Decreasing %RH

                      65



                      60



                      55




 Relequa Analytical Systems   (© 2008 – 2012)
The Second Principle of ERH
 A material placed in an environment with %Relative
  Humidity below its ERH will always give out in
  moisture, provided that it has free moisture available to
  do this, with a typical profile type:
                                 Moisture Loss Profile
                        50
                        48
                        46
                        44
                        42
                  %RH




                        40                               Increasing %RH
                        38
                        36
                        34
                        32
                        30




 Relequa Analytical Systems   (© 2008 – 2012)
Moisture Profiling for Problem Solving

Relequa provides powerful moisture problem solving data:
 Measurements are “real life”, reflecting processing and
  laboratory conditions
 The information is a graphic output = Moisture Profile
 The powerful analytical information is provided by the
  Moisture Profile dynamics – the absolute ERH values
  are less important
 This “complete moisture profiling system” can always
  determine the profile and the ERH



 Relequa Analytical Systems   (© 2008 – 2012)
Key Features - 1
  Graphic moisture profile output gives novel information about
 the interaction of moisture with materials
  The system is designed for analysis in ambient conditions
 reflecting the real life situation of pharmaceutical processing
  Instant test data compared with other moisture-related
 analytical methods.
  Non-destructive test enabling the sample to be utilised for
 further complementary investigations
  Dual sample chambers enabling comparative tests or facilitating
 multi-sample testing
  Samples can be solids, powders, gels, creams, and liquids
 requiring no special preparation
  Robust unit capable of high volume sample analysis over short
 periods

Relequa Analytical Systems   (© 2008 – 2012)
Key Features - 2
  Intuitive system software:
       User-friendly and requires no calculations
       “Sample Moisture Test” function assesses sample moisture
      status in 15 minutes or less
      Integral “Moisture Profiling” function conducts a full sample
     analysis and moisture profile
       “View Data” shows the moisture profile as the test is being
      performed
  IQ/OQ/PQ documentation for installation with use of traceable
 calibration standards
  Remote Data Acquisition
  CE approved



Relequa Analytical Systems   (© 2008 – 2012)
Moisture Problems Solved


Outcome:
 Relequa gives a new understanding about the impact of
  moisture on pharmaceutical materials and products to
 solve moisture problems quickly and save time and costs
                     for the industry




 Relequa Analytical Systems   (© 2008 – 2012)
Areas of Application

 R&D. Characterise material moisture interactions to
  pre-empt later process problems
 Manufacturing development. As an existing moisture
  problem solver and predictor
 Packaging development and performance. Solves
  problems and helps in the choice of effective
  packaging




 Relequa Analytical Systems   (© 2008 – 2012)
Case Study Examples

   Moisture release / uptake activity in tablets
   Cause of hydrolysis problems uncovered
   Moisture sensitivity in liquids
   Packaging problems with pharma products
   Stability testing




Relequa Analytical Systems   (© 2008 – 2012)
Further Information

Visit our website, contact Relequa or our regional
representatives for more information:
   Relequa brochure
   Leaflet “How the Relequa System Works”
   Case studies
   Support service




Relequa Analytical Systems   (© 2008 – 2012)
Relequa Analytical
                    Systems Ltd
                     Kilminion South, Ballinroad, Dungarvan,
                              Co Waterford, Ireland
                   T: +353 (0) 58 43760 / +353 (0) 66 976 2780
                  E: info@relequa.com W: www.relequa.com




               Solving moisture problems instantly – saving
                       costs for the pharma industry


Relequa Analytical Systems   (© 2008 – 2012)

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The relequa moisture profiling system

  • 1. Relequa® Analytical Systems Ltd Solving moisture problems instantly – saving costs for the pharma industry RELEQUA MOISTURE PROFILING SYSTEM
  • 2. Equilibrium Relative Humidity (ERH) The Relequa instrument exploits ERH technology: “The ERH of a material is the %Relative Humidity of the air surrounding it at the equilibrium point of moisture absorption/desorption” Relequa Analytical Systems (© 2008 – 2012)
  • 3. Equilibrium Relative Humidity ERH is then: A dynamic state for a material in equilibrium when its rate of moisture uptake is equal to the rate of free moisture being released from the surface of the material Relequa Analytical Systems (© 2008 – 2012)
  • 4. How the Relequa System Works  Moisture interaction / migration in a pharma product environment is driven by the ERH of the product material(s)  As a result, changes in this environmental system (eg. RH, temperature) can cause moisture interactions.  These interactions can impact on chemical and physical properties of the material.  The degree of change is determined by the Relequa system’s moisture profiling dynamics Relequa Analytical Systems (© 2008 – 2012)
  • 5. How the Relequa System Works  Relequa’s analysis method works by detecting these changes in immediate environmental conditions  The output is the Moisture Profile: Relequa Analytical Systems (© 2008 – 2012)
  • 6. The Principles of ERH The two principles of ERH are relevant to the investigational capabilities of the Relequa Moisture Profiling system Relequa Analytical Systems (© 2008 – 2012)
  • 7. The First Principle of ERH  A material placed in an environment with %Relative Humidity above its ERH will always take in moisture from the environment with a typical profile type: Moisture Uptake Profile 80 75 70 %RH Decreasing %RH 65 60 55 Relequa Analytical Systems (© 2008 – 2012)
  • 8. The Second Principle of ERH  A material placed in an environment with %Relative Humidity below its ERH will always give out in moisture, provided that it has free moisture available to do this, with a typical profile type: Moisture Loss Profile 50 48 46 44 42 %RH 40 Increasing %RH 38 36 34 32 30 Relequa Analytical Systems (© 2008 – 2012)
  • 9. Moisture Profiling for Problem Solving Relequa provides powerful moisture problem solving data:  Measurements are “real life”, reflecting processing and laboratory conditions  The information is a graphic output = Moisture Profile  The powerful analytical information is provided by the Moisture Profile dynamics – the absolute ERH values are less important  This “complete moisture profiling system” can always determine the profile and the ERH Relequa Analytical Systems (© 2008 – 2012)
  • 10. Key Features - 1  Graphic moisture profile output gives novel information about the interaction of moisture with materials  The system is designed for analysis in ambient conditions reflecting the real life situation of pharmaceutical processing  Instant test data compared with other moisture-related analytical methods.  Non-destructive test enabling the sample to be utilised for further complementary investigations  Dual sample chambers enabling comparative tests or facilitating multi-sample testing  Samples can be solids, powders, gels, creams, and liquids requiring no special preparation  Robust unit capable of high volume sample analysis over short periods Relequa Analytical Systems (© 2008 – 2012)
  • 11. Key Features - 2  Intuitive system software:  User-friendly and requires no calculations  “Sample Moisture Test” function assesses sample moisture status in 15 minutes or less  Integral “Moisture Profiling” function conducts a full sample analysis and moisture profile  “View Data” shows the moisture profile as the test is being performed  IQ/OQ/PQ documentation for installation with use of traceable calibration standards  Remote Data Acquisition  CE approved Relequa Analytical Systems (© 2008 – 2012)
  • 12. Moisture Problems Solved Outcome: Relequa gives a new understanding about the impact of moisture on pharmaceutical materials and products to solve moisture problems quickly and save time and costs for the industry Relequa Analytical Systems (© 2008 – 2012)
  • 13. Areas of Application  R&D. Characterise material moisture interactions to pre-empt later process problems  Manufacturing development. As an existing moisture problem solver and predictor  Packaging development and performance. Solves problems and helps in the choice of effective packaging Relequa Analytical Systems (© 2008 – 2012)
  • 14. Case Study Examples  Moisture release / uptake activity in tablets  Cause of hydrolysis problems uncovered  Moisture sensitivity in liquids  Packaging problems with pharma products  Stability testing Relequa Analytical Systems (© 2008 – 2012)
  • 15. Further Information Visit our website, contact Relequa or our regional representatives for more information:  Relequa brochure  Leaflet “How the Relequa System Works”  Case studies  Support service Relequa Analytical Systems (© 2008 – 2012)
  • 16. Relequa Analytical Systems Ltd Kilminion South, Ballinroad, Dungarvan, Co Waterford, Ireland T: +353 (0) 58 43760 / +353 (0) 66 976 2780 E: info@relequa.com W: www.relequa.com Solving moisture problems instantly – saving costs for the pharma industry Relequa Analytical Systems (© 2008 – 2012)