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Relequa Analytical Systems Ltd is a technology company which manufactures and supplies a unique moisture profiling analytical instrument. The instrument gives rapid output data about the impact of moisture on pharmaceutical materials and products. The way that Relequa looks at moisture uptake and loss gives an analytical profile which provides powerful information not previously available to the pharmaceutical industry. By doing this, Relequa gives a new understanding about moisture problems and saves costs for our customers by reducing the time taken to solve such problems. The Relequa moisture profiling system is applicable for R&D, manufacturing development, and packaging development and performance. When Relequa is used for example in R&D formulations work, new characteristics about how moisture interacts with materials are learned, so that problems which might occur later in the manufacturing process can be pre-empted. The instrument can analyse materials in all forms including tablets, capsules, powders, liquids, gels and creams in both packed and free states. The instrument applies equally as well to any industry where materials and products are impacted by moisture.
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Relequa® Analytical Systems LtdSolving moisture problems instantly – saving costs for the pharma industry
RELEQUA MOISTURE PROFILING SYSTEM
Equilibrium Relative Humidity (ERH)
Relequa Analytical Systems (© 2008 – 2012)
“The ERH of a material is the %Relative Humidity of the air surrounding it at the equilibrium point of
moisture absorption/desorption”
The Relequa instrument exploits ERH technology:
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:
Relequa Analytical Systems (© 2008 – 2012)
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%R
H
Moisture Uptake Profile
Decreasing %RH
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:
Relequa Analytical Systems (© 2008 – 2012)
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%R
H
Moisture Loss Profile
Increasing %RH
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
Relequa Analytical Systems (© 2008 – 2012)
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 liquidsrequiring no special preparation Robust unit capable of high volume sample analysis over short periods
Key Features - 2
Relequa Analytical Systems (© 2008 – 2012)
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
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 (© 2008 – 2012)
Relequa Analytical Systems Ltd
Kilminion South, Ballinroad, Dungarvan,Co Waterford, Ireland
T: +353 (0) 58 43760 / +353 (0) 66 976 2780E: [email protected] W: www.relequa.com
Solving moisture problems instantly – saving costs for the pharma industry
