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PHARMACEUTICAL |
The pharmaceutical industry is one of the largest users of humidity measurement equipment. Most drugs are sensitive to variations in humidity and moisture levels, so these need to be considered and controlled for the final products to be consistent in quality and performance.
Application: Stability Test
Drugs are tested in "accelerated conditions" to obtain information on the product stability, the integrity of packaging and therefore shelf life. Humidity instruments are used to both control (transmitters) and monitor (transmitters or data loggers) these conditions.
Environmental chambers are used to generate accelerated conditions
Products:
Transmitters
Dataloggers
Application: Production areas.
Production areas are carefully monitored to verify conditions. To avoid unnecessary validation stand alone data acquisition devices are used, typically chart recorders, as they have no software and produce a permanent record. Validated data loggers offer the same convenience with improved data manipulation, ease of use and lower cost.
Products:
Transmitters
Dataloggers
Portable
Application: Production machines; driers, tableters, and coaters are all sensitive to humidity.
Quality control normally consists of machine monitoring, area monitoring and final product ERH measurement.
Products:
Transmitters
Dataloggers
Applications: Quality Assurance ERH testing in raw and finished powders, granular or tablets.
Often low ERH conditions are the ideal environment for powders and tablets. Some aW instruments use "Gel" polymer sensor which cannot operate below 10%ERH.
Products:
Water Activity
Applications: Animal house conditions are governed by strict rules including %rh conditions.
Animal houses are hosed down when cleaned, hence the need for industrial instruments with an IP65 rating.
Products:
Transmitters
Dataloggers
Meteorological
Applications: Clean Room environments are humidity critical.
A clean room environmental monitoring system (EMS`s) is always validated to conform with regulatory requirements and is therefore supplied by a third party specialist. Inclusion into the User Requirement Specification (URS) ensures instrument inclusion.
Products:
Transmitters
Dataloggers
Portable
Applications: Transportation, vehicles and freight forwarding storage facilities.
Often a pharmaceutical organisation will require its freight forwarders to monitor storage facilities and inform them of any undesirable conditions
Products:
Dataloggers
Portable
Applications: Research and Development; humidity is measured during all phases of drug development; within the lab, ERH of the material, and within machines used in pilot plants.
When a drug has been successfully tested and a licence for sales approved, that licence will stipulate that the exact method of production used in the pilot plant is mirrored in the full scale production plant.
Products:
Transmitters
Dataloggers
Portable
Water Activity
Applications: Building Management Systems (BMS) that supply conditioned air to "critical" areas always have humidity and temperature control.
Industrial transmitters are used in Air Handling Units (AHU`s) where the humidity is high. Portable instruments are often used to spot check areas and ducts.
Products:
Transmitters
Portable
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