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.


SL 1011
Kit d’Enregistreur de Température
Pour la surveillance de la température et le calcul de la valeur A0 dans les lave-bassins
SL 3001
Kit de Validation
pour petits stérilisateurs à vapeur
Test électronique Bowie&Dick
EBI 16
in accordance to ISO 11140-4
Robust logger for sample control
EBI 11-T230
Robust temperature data logger for process validation of production processes.
Enregistreur de validation
EBI 12-T241
bendable sensor for placement in cavities
Enregistreur de validation
EBI 12-T220
Bendable probe for placement in steam sterilizer drain
Temperature validation logger
EBI 11-T237
Validation logger for temperature measurement in the doctors surgeries
SL 3101
Kit Complet de Validation
pour grands stérilisateurs à vapeur
Robust logger for sample control
EBI 11-T231
Robust temperature data logger for process validation of production processes.
Temperature validation logger
EBI 11-T236
Validation logger for temperature measurement in the doctors surgeries
Enregistreur de validation
EBI 12-T240
Validation logger to measure in steam sterilizer
Pressure logger for pasteurization control
EBI 11-TP110
Raccord fi leté M5
Temperature validation logger
EBI 11-T235
Validation logger for temperature measurement in the doctors surgeries
Validation logger with fast response time
EBI 11-T240
Validation logger with fast response time for use where space is limited
Enregistreur de validation polyvalent
EBI 12-T222
For final inspection after the repair, but also for validation.
SL 3111
Kit Complet de Validation
pour grands stérilisateurs à vapeur
Mini validation pressure logger
EBI 11-P111
Mini validation pressure data logger to messure in steam sterilizers and Washer disinfectors.
Mesures jusqu'à +400 °C
EBI 12-T221
Measurement up to +400 °C