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Industrias Högner has a Department for the Validation of
sterilization equipment and processes whose state-of-the-art
instruments and technical capacity render it unique in Argentina.
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Studies performed by this
advanced department include the qualification and thermal
profiles of those pieces of equipment where temperature
or pressure are critical parameters, such as Autoclaves,
Ovens and sterilization-depyrogenation tunnels, stability
chambers, freezers, etc.
The aim of thermal validation is to verify that the temperature
of an equipment or process reach and keep its specifications,
trustfully and repeatedly, in accordance with the current
norms and regulations. Thus, a studies on temperature
distribution on empty chamber, heat penetration in different
loads, death-rate, etc are carried out, using computerized
KAYE instruments of renown prestige within the Pharmaceutical
Industry.
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Certification of instruments
We have cutting-edge instruments awarded with calibration
certificates according to ISO, to calibrate, certify and
record analogue or electronic pressure and temperature
instruments, delivering the corresponding calibration
of deviation certificate. All instruments used are traceable
to primary patterns.
Qualification
We are trained to perform the complete qualification
of our lines equipment. We count with the highest technical
ability and experience within this field. We are qualified
to performed Design Qualifications DQ as well as FAT
(Factory Acceptance Test) and SAT (Site Acceptance Test)
protocols.
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