Validation

All thermal processes for reducing germs on surfaces or in solutions must be validated initially and then regularly. This is the only way to ensure patient safety, the top priority in the manufacture of pharmaceutical products. In order to enable validation according to EU GMP Guideline Annex 15 Qualification and Validation, the uniform distribution of all important parameters within the sterilizers or autoclaves must be demonstrated. The ideal data loggers for this application are the data loggers of the EBI 12 and EBI 11 family. EBI 12-T22x and EBI 12-T24x Series data loggers combine good measurement accuracy and functionality of a data logger together with the robustness that is required for use in sterilization processes. With the Winlog.validation software it is possible to create templates which can be used to evaluate the validation runs. Documents for IQ and OQ are included in the software package.


EBI 11-T240
Mini-temperature logger
Bendable metal probe
EBI 12-T222
Temperature Data Logger
rigid needle
SL 3111
Validation-Set for validation of large steam sterilizers
for large steam sterilizers
EBI 11-P111
Mini-Pressure Logger
Luer-Lock connection
EBI 11-T233
Mini-Temperature Logger
Rigid metal probe
EBI 12-T221
Temperature Data Logger
Bendable metal probe
SL 1011
Temperature Data Logger Set
For temperature monitoring and A 0 value calculation in bedpan washers
SL 3001
Validation-Set
for washer-disinfectors
EBI 16
Bowie Dick Test Data Logger
according to the norms EN 285 / ISO 17665
EBI 11-T230
Mini-Temperature Logger
Rigid metal probe
EBI 12-T241
Temperature Data Logger
Bendable metal probe
EBI 12-T220
Temperature Data Logger
Bendable metal probe
EBI 11-T237
Mini-Temperature Logger
Rigid blunt metal probe
SL 3101
Validation-Set for validation of large steam sterilizers
for large steam sterilizers
EBI 11-T231
Mini-Temperature Logger
Rigid metal probe
EBI 11-T236
Mini-Temperature Logger
Rigid blunt metal probe
EBI 12-T240
Temperature Data Logger
Bendable metal probe
EBI 11-TP110
Mini-Pressure/Temperature-Data Logger
M5 thread connection
EBI 11-T235
Mini-Temperature Logger
Rigid blunt metal probe