Thermal / Temperature & Environmental Mapping
Due to the potential down-time required for execution of thermal mapping studies, it is paramount that the critical components for a successful conclusion are in place. This can only be achieved by extensive knowledge and the use of state-of-the-art equipment that we are proud to offer.
Valcomm provides thermal/temperature mapping expertise with the extended capability to accurately validate extreme environments such as cryogenics and autoclaves as well as more common areas such as product storage cold stores, freezers, warehouses and stability suites.
Our extensive knowledge in this field enables Valcomm to provide an unrivalled thermal/temperature mapping service of processes (autoclaves, depylrogenation tunnels, SIP, freeze driers), laboratory equipment (ovens and incubators) and product storage areas (cold stores/fridges, freezers, warehouses and stability suites).
We also provide advice on industry trends using best practice methodologies, however we maintain the flexibility to tailor our services or to work within the refines of a client’s established methods and protocols as required.
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Our Thermal / Temperature mapping Services may include:
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A review of work completed and current validation status
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Protocol and procedure definition and preparation
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Temperature mapping
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Humidity mapping
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Bespoke equipment adaptors for all applications to enable exact positioning of sensors
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Calibration and positioning of sensors
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Calculation of Mean Kinetic Temperatures and compliance with USP general chapter <1079>
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Document Reviews
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Practical training for your technicians
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Data analysis and interpretation
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Troubleshooting
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Consultancy
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Autoclave validation service to EN285, HTM2010 standards or annual thermal mapping
From lab equipment to Environmental Monitoring Systems (EMS) there is a high likeliness that associated software will be defined as a computer system under the Good Automated Manufacturing Practice (GAMP) framework, therefore our qualification and validation services may also be of interest to the pharmaceutical and manufacturing industries.
All mapping exercises undertaken by Valcomm are executed using industry standard equipment such as hot blocks, IRTD’s, remote data loggers (Log Tag, Rotronic, Kimo Tech, Data Trace), Yokogawa chart recorders and KAYE 2000 validators in accordance with current EU and US guidelines including ASTM:2500, ICH guidelines and the Orange Guide.
To discuss your specific mapping requirements, contact Valcomm today