|
Thermal or temperature mapping is essential to verify that a particular process,
piece of equipment or product storage area creates and maintains the correct
temperature for its purpose and its implementation is a requirement of the FDA,
MHRA and IMB. Honeyman perform thermal/temperature mapping exercises
across a wide temperature and humidity range from -80oC to 400oC,
accurately validating extreme environments from autoclaves to cold product
storage areas and stability suites.
With a number of ex-industry specialists and leading experts who deliver
top-level consultancy support and advice, Honeyman are usually the first point of contact when
operational difficulties and problems of
non-compliance and unreliability arise. Through the development and
application of 'Right First Time' validation approaches our impartial and
expert advice and best
practice guidance often leads to cost saving benefits and process optimisation.
Our team of Chemists, Microbiologists and Engineers support our Validation
Professionals by combining their skills and experience to provide an unrivalled
range of services which encompass more than just physical temperature mapping of
processes (autoclaves, depyrogenation tunnels, SIP, freeze driers), laboratory
equipment (ovens and incubators) and product storage areas (fridges, freezers,
warehouses and stability suites).
Whether your site already has
established protocols and procedures and you simply need additional resource to
support your team or, you need a complete thermal mapping solution encompassing
protocol development, project implementation through data analysis and
interpretation, Honeyman can tailor a package of services to meet your exact
requirements and budget based on current best practice and industry trends.
Our package of services typically
includes:
-
A review of work completed and
current validation status
-
Protocol and
procedure definition and preparation
-
Temperature mapping
-
Bespoke engineering solutions
and equipment furniture such as racking, trolleys and jigs
-
Bespoke equipment adaptors for
all applications to enable exact positioning of sensors
-
Equipment calibration
-
Calculation of Mean Kinetic
Temperatures
-
Document Reviews
-
Practical training for your
technicians
-
Data analysis and
interpretation
-
Troubleshooting
-
Consultancy
Our team of highly skilled
validation specialists work with industry standard equipment such as; hot
blocks, IRTD's, remote data loggers, Yokogawa chart recorders and KAYE 2000
validators in
accordance with current EU and US guidelines including; ASTM:2500, ICH
guidelines and the Orange Guide.
Our fully calibrated and certified KAYE 2000
validators are available for hire to clients with existing validation
departments who need cover whilst their own equipment is being validated or
maintained -
please contact us for details. |
